FDA Alerts

FDA IVC Filter News

Almost since it became known that IVC filters designed to fight blood clots could instead cause serious injuries to patients, FDA news of IVC filters has arisen. Indeed, such FDA warnings and reports about IVC filter defects and side effects has been common for several years. History of IVC Filters and the FDA First, you…

Essure FDA Investigation

What is a clear sign that Essure birth control devices are defective? The U.S. Food and Drug Administration is launching a probe of the contraceptive device. This Essure FDA investigation began in mid-April of 2015 and also concerns alleged deceit by Essure manufacturer Bayer Healthcare Pharmaceuticals Inc. A petition which was filed on behalf of…

Paxil and Pregnancy

Back in 2006, the Food and Drug Administration (FDA) announced that research evaluations of the prescription antidepressant Paxil discovered that taking Paxil during pregnancy, specifically during the first three months of pregnancy, may significantly raise the risk of having an infant with birth defects. The most common Paxil birth defects found were congenital (present at…

Pradaxa FDA Alert

In December of 2011, the United States Food and Drug Administration (FDA) released a Safety Announcement regarding recent studies conducted about Pradaxa causing internal bleeding. The Food and Drug Administration (FDA) stated that they were evaluating post-marketing (after sale) reports of severe bleeding events reported in Pradaxa patients. Pradaxa is a popular anticoagulant on the…

FDA Alert: Topamax Oral Clefts Risk in Infants

FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (topiramate) The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated…

Baby Slings Can Cause Infant Suffocation

The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve…

ev3 Endovascular Inc. Trailblazer Support Catheter Recall

ev3 Endovascular, Inc. and the FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death. See…

New USP Standards for Heparin Products

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be Needed to Achieve Desired Anticoagulant Effect in Some Patients New Heparin to Ship Starting October 8 The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of…

FDA Reviewing Weight Loss Drug Orlistat

FDA Issues Early Communication about Ongoing Safety Review of Orlistat. Weight loss drug review includes both prescription drug Xenical and OTC drug Alli. The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical…

Orlistat (Marketed as Alli and Xenical) Safety Review

FDA’s Early Communication about the Ongoing Safety Review of Orlistat. FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Xenical (orlistat 120mg) was approved as a prescription product by…