Follow us:

MedWatch Safety Alerts

MedWatch Safety Alert RSS Feed

FDA MedWatch Safety Alerts

BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
Posted: March 21, 2017, 5:00 pm
Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
Posted: March 18, 2017, 2:00 pm
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Posted: March 15, 2017, 4:02 pm
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Posted: March 14, 2017, 5:20 pm
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Posted: March 9, 2017, 7:23 pm
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Posted: March 9, 2017, 6:40 pm
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Posted: March 9, 2017, 4:00 pm
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Posted: March 8, 2017, 6:30 pm
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: March 8, 2017, 1:00 am
Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
Posted: February 27, 2017, 6:00 pm
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Posted: February 25, 2017, 1:00 am
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: February 22, 2017, 1:00 pm
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Posted: February 16, 2017, 2:30 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: February 15, 2017, 1:30 pm
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
Posted: February 9, 2017, 4:00 pm
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Posted: February 9, 2017, 2:35 pm
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Posted: February 9, 2017, 12:45 pm
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
Posted: February 2, 2017, 6:24 pm
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Posted: January 30, 2017, 7:10 pm
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Posted: January 27, 2017, 6:55 pm