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The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.
FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.
Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.
The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.
If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Identified facility violations could result in an increased risk of infection transmission.
FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.
Seal failure could result in patient blood loss.
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.
Drug labels for Comtan and Stalevo will remain unchanged.
Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.
Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.
If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.
Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.
FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.
A patient not receiving enough oxygen can result in possible injury or death.
If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.
New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Over or under infusion of fluids to the patient has the potential to cause patient injury or death.
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.
Reports of internal flash fire when the OxyTOTE is mishandled or dropped.
Parenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome.
Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.
Patients should consider having their mammograms re-evaluated at a certified facility.
If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.
Increased rate of pump thrombosis, high rate of stroke, bleeding complications.
Cases of PML in two patients with no prior exposure to immunosuppressant drugs.
Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection.
Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.
FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.
If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
FDA will update recall with new information as it becomes available.
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.
Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015
Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
Can lead to to administration of more drug than was prescribed.
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies.
Possibility of a tear on the left atrial wall during use of the device.
Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected.
Patients may need a repeat mammogram or additional medical follow-up.
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.
The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
Separation could result in required intervention to prevent permanent impairment or damage.
Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Risk of potentially life-threatening allergic reactions.
If not properly reprocessed patients may be exposed to serious infections.
The facility may not perform mammography due to the revocation of its accreditation.
Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
Can lead to device failure, possible product contamination, and potential serious adverse health consequences.
Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Risk of injury or death resulting from prolonged interruption in therapy.
Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.
FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Patients may be exposed to serious infections.
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Pregnant women urged to discuss all medicines with their health care professionals before using them.
Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.
An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
There have been reports of serious adverse events associated with the use of certain of these products.
Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer).
Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.
Can increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Serious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if taken with other medications that work similarly.
Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Symptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.
FDA advises practitioners to approach the application of these interventions with caution.
May result in a delay in therapy.
Using these recalled devices may cause ineffective patient treatment.
May result in a delay in therapy.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Symptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Risk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.
Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.
Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke
Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death.
The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.
FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.
There is the possibility of fungal infection should patients come in contact with the mold.
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems.
Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.
Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.
Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014
Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.
Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.
September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.
A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.
The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.
FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.
Use of the affected product may cause serious adverse health consequences, including death.
Ventilator shut-off from power failures may lead to serious patient injury or death.
Patients in Oregon and Washington may be at risk of serious infections which may be life threatening.
One lot may have experienced temperature excursions during shipment.
Product failure could cause a potential delay in controlling axilla hemorrhage.
Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
The labeled expiration date is longer than the known stability of the product.
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
FDA approves label changes after review of a five year safety study.
Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.
Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.
Compromised sterility of a product may lead to risk for infection
Compromised sterility of a compounded preparation may lead to risk for infection.
Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.
Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.
Potential adhesion defect which may lead to infection.
Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.
Use of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare.
Fragments of the sheath could possibly block blood vessels.
Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.
Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.
Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.
Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli.
Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.
Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.
Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.
Failure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death
If infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Voluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.
May present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke. May interact, in life-threatening ways, with other medications.
The use of affected product may cause serious adverse health consequences, including death.
Device failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death.
Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization.
All lots of non-expired products being recalled.
Too much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart.
Reactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.
Recommendations for use remain the same; label updates required.
Use could result in serious muscle injury, particularly if taking with prescription “statins”; patients with pre-existing liver disease may be at an increased risk for liver injury.
Patients who had a mammogram performed at Big Sky Diagnostic Imaging should speak to their health care providers about whether their mammograms need to be repeated.
Warning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
Reports of 12 serious injuries and one death.
Docetaxel contains alcohol, which affects the central nervous system.
Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.
Products may substantially increase blood pressure and/or pulse rate in some patients.
Injected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy.
Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 06/13/2014.
FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification.
One lot of 3.0mm sized connectors were placed in packages labeled as 3.5mm.
Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could lead to serious health consequences, including death.
Cancer-causing risk in addition to increased blood pressure and/or pulse rate.
Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Particulates could cause blockage of blood flow, which could be life-threatening.
Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.
Device malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction.
Bacterial contamination of the dialysate may lead to bacteremia or systemic infection.
A fatal outcome is possible, especially with the high risk population.
"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.
May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.
May interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Risk of increased blood pressure and/or pulse rate.
Drug Safety Labeling Changes, April 2014
Risk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy.
FDA recommends a decreased starting dose for both women and men.
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response.
Study finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding.
Failure could result in the balloon pump shutting down without warning, which could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.
Therapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory.
may contain undeclared amounts of sildenafil and tadalafil.
Risk of increased blood pressure and/or pulse rate.
Risk of increased blood pressure and/or pulse rate.
May Result in Over-Infusion or Delay of Therapy.
A delay or interruption in therapy has a worst case potential to result in significant injury or death.
Pump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
Risks include unknown quality, safety, and efficacy.
Recent FDA inspection of manufacturer found extensive violations of federal regulations intended to assure the quality of product.
Failure could result in the pump stopping and lead to serious adverse health consequences, including death.
Risk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.
Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death.
Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.
Use of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke.
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate.
Contains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.
Potential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.
Defect may cause serious adverse health consequences, including hypoxemia and death.
Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014.
Use of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.
Risk of increased blood pressure and/or pulse rate.
Battery depletion will require manual ventilation until the device is connected to main power.
Health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.
Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure.
Some packages of the product were tampered with and may contain product that is not authentic.
Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.
Undeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established.
Exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions.
Drug Safety Labeling Changes, February 2014
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.
Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.
Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
Class 1 recall of computer-based system.
Risk of rare but serious adverse events associated with infusion containing particulates.
UPDATED 03/14/2014. Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. Originally posted 06/01/2012.
Presence of oxidized stainless steel particulate may put a patient at risk from strong magnetic field exposure such as MRI, and other adverse events resulting in serious life-threatening complications.
Lack of sterility assurance has the potential to result in surgical infection.
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal.
Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin.
Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.
Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.
Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill.
Use of this recalled product may result in serious adverse health consequences.
If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.
Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction.
Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death.
Use of an inhaled product with glass particles has potential to cause choking which could be life-threatening. Aerosolization of small glass particles in airways could result in recurrent infections.
Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.
FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.
FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.
FDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
DMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack.
Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Risk of serious or life-threatening allergic reaction.
Production facility in Vietnam reviewing manufacturing sterility controls.
Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.
Cartridge leak could potentially result in the device delivering too much or too little insulin.
Undeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. Pro ArthMax has a reasonable probability of resulting in fatal adverse events.
Analysis found these products to contain undeclared Sildenafil and/or Tadalafil, may interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.
Safety Labeling Changes includes 39 products with revisions to Prescribing Information.
Reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose, resulting in serious adverse effects, in some cases resulting in death.
If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.
The fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver.
A potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
Undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients.
If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.
The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.
Prolonged erections (priapism) can lead to permanent damage to the penis.
Two lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
Misleading claims about a nipple aspirate test may lead patients to not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported.
When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
Sample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss.
Falsely low blood glucose results can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.
Voluntary recall of one lot due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism.
Potential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode.
Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.
Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.
May result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.
FDA is currently reviewing data for the potential use of these auto-injectors beyond their labeled expiration dates, in order to mitigate any potential shortages.
Undeclared Fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Use of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.
Cases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion.
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Undeclared hydroxylthiohomosildenafil and aminotadalafil (PDE-5) inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Undeclared Desmethylcarbondenafil, a posphodiesterase (PDE-5) inhibitor, and dapoxetine, an ingredient not approved by the FDA, may present a health risk which could be life threatening.
In the event a sterile product is compromised, patients are at risk for very serious infections.
Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm)
Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.
Undeclared Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Clinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death.
Risk of aplastic anemia and allergic reactions.
The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety.
Particulate could potentially migrate into a patient’s bloodstream.
All anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture.
Use of defective product may lead to tip separation and embolization.
Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose. Posted 11/02/2013
September 2013 drug safety labeling changes
UPDATE: Boxed Warning and other labeling changes approved.
May prevent users from turning off CO2 gas flow during an endoscopic procedure, leading to risk of peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.
Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013
Serious adverse health consequences, including complications of bleeding, loss of limb, heart attack, or stroke.
Finding of bacterial growth.
Tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
May result in the inability to access certain menu functions which could possibly lead to delay in treatment.
A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.
Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.
May substantially increase blood pressure and/or pulse rate or present a significant risk for patients with a history of certain cardiovascular conditions or stroke.
May illicit inflammatory responses, both chronic and acute, and may be life threatening.
FDA advises consumers to stop using products labeled OxyElite Pro while the investigation continues.
In extreme cases, may cause a failure of the automatic ventilation function of the device.
Atossa will remove existing product from the market until concerns are addressed.
May result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.
Defect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.
Administration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response.
Potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.
Patients may receive a higher than expected tidal
May become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation.
BOXED WARNING describes risk for FDA-approved and non-approved uses.
UPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013
Lab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.
Hepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported.
May interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels.
Contains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Contains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Accidental exposure to fentanyl can cause serious harm and death in children, pets, and others.
May result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
May substantially increase blood pressure and/or pulse rate in some patients and presents a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.
One lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.
Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.
May contain tiny plastic particles.
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Potential risk for eye infection.
Questions Surrounding an Independent Third Party's Sterility Testing
Defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.
Particle confirmed by Hospira as human hair.
Risk of thromboembolism and pulmonary emboli, some life-threatening.
Patient has developed a rare and serious brain infection after taking the drug.
Post-operative fracture of the pin that connects the head to the plate body.
May interact with nitrates found in some prescription drugs,lower blood pressure to dangerous levels or cause side effects, such as headaches and flushing.
If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
Methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.
FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac.
Undeclared Sildenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.
Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.
May substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients.
Aidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.
Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.
Increased risk of over-infusion or under-infusion if the infusion is started with the incorrect rate. This can cause serious adverse health consequences, including death.
Bacterial infections have been potentially associated with contaminated calcium gluconate infusions.
The company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards.
Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.
Consuming this product potentially could result in dizziness and cause public health risk.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk.
Sibutramine and Phenolphthalein may pose health threats or interact in life-threatening ways with other medications a consumer may be taking.
Risk of thromboembolism, some life-threatening (such as pulmonary emboli), as well as other serious adverse events.
Events are rare but can be fatal.
Patients weighing more than 200 pounds and/or those with high levels of activity are at higher risk.
Sterile compounded products distributed nationwide
A false test result may lead to an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.
Effects from use may include dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, or depressed, or having hallucinations.
Facilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system
Nizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks, and alternative therapeutic options are not available or tolerated.
Using anabolic steroid-containing products may cause acute liver injury and some of the cases reported have resulted in hospitalization.
Use of this product may cause serious adverse health consequences, including death.
Some products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.
The recommended pump refill date, computed by the Control Unit, may be incorrect.
These products pose a health threat to Consumers because Sibutramine is known to increase blood pressure and/or pulse rate and other related health risks.
Using an oversized tracheostomy tube may cause permanent injury to the trachea.
Lab tests revealed products contain PDE 5 inhibitors and other drug ingredients that can be life threatening.
Use of these products, which contain Sildenafil, can result in decreased blood pressure, light-headedness, and dizziness.
May result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
Blade may break off in patients’ mouth, where it may be swallowed or block the airway. This can lead to serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death.
Risk of pregnancy.
Enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization.
If vial is cracked, integrity of the vial and sterility of any product remaining could not be assured.
If present, the administration of glass particulate poses a potential safety risk to patients.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.
Products have been found to contain undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
FDA has analyzed recent data indicating increased mortality and renal injury in critically ill adult patients who are treated with HES solutions. Posted 06/24/2013
Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.
Physician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient.
Ventilator support may be lost with potentially no audible alarm from the ventilator.
Consumers may inadvertently take Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage.
Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013
Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013
Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
MedWatch May 2013 drug safety labeling changes
UPDATED 06/13/2013. FDA identified the specific bacterial and fungal growth in two MPA lots. Originally posted 05/24/2013.
Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.