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FDA MedWatch Safety Alerts
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication
Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.
Posted: April 17, 2015, 4:15 pm
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub
Separation could result in required intervention to prevent permanent impairment or damage.
Posted: April 16, 2015, 1:00 pm
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter
Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Posted: April 10, 2015, 2:40 pm
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
UPDATED 04/08/2015. Wallcur Practi-IV solutions bags are recalled.
Posted: April 8, 2015, 6:30 pm
Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance
Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.
Posted: April 2, 2015, 3:45 pm
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
Risk of potentially life-threatening allergic reactions.
Posted: March 31, 2015, 11:00 am
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
If not properly reprocessed patients may be exposed to serious infections.
Posted: March 26, 2015, 7:00 pm
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems
The facility may not perform mammography due to the revocation of its accreditation.
Posted: March 24, 2015, 7:10 pm
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone
Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.
Posted: March 24, 2015, 4:50 pm
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug
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.
Posted: March 23, 2015, 6:00 pm
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks
If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.
Posted: March 19, 2015, 4:00 pm
Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.
Posted: March 12, 2015, 11:30 am
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene
Can lead to device failure, possible product contamination, and potential serious adverse health consequences.
Posted: March 11, 2015, 12:30 am
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction
Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015
Posted: March 9, 2015, 10:00 pm
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.
Posted: March 6, 2015, 7:10 pm
Risk of injury or death resulting from prolonged interruption in therapy.
Posted: March 6, 2015, 3:30 pm
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.
Posted: March 6, 2015, 1:42 pm
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
UPDATED 3/4/2015. The Safety Communication has been updated. Updated Information for Healthcare Providers Regarding Duodenoscopes is provided.
Posted: March 4, 2015, 5:00 am
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
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.
Posted: March 3, 2015, 4:00 pm
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Posted: February 27, 2015, 3:40 pm