Study Suggests Some Epileptic Drugs May Cause Birth Defects
RxFilter, a data aggregation and refinement process company, has suggested that two epilepsy drugs defined by the FDA as having “no known human risk” may actually be dangerous to a human fetus, according to news sources. If the evidence is conclusive, it may prompt the Food and Drug Administration to reclassify the drug from a… read more
“Gluten-Free” Labels Under New Regulations
Currently unregulated “gluten-free” labels may soon be subject to regulation by the Food and Drug Administration, according to recent news sources. Gluten is the substance that makes bread rise, keeps it doughy, and provides texture and flavor. Many people have sensitivity to this product, especially those with Celiac disease, a disease that can lead to… read more
Carol’s Cuts Affected by Contaminated Cantaloupe
The Food and Drug Administration has released a new recall for Carol’s Cuts LLC, and their fruit mixed medley product due to a Listeria monocytogenes contamination, according to news sources. The product subject to recall includes 594 pounds of cantaloupe in 5-pound trays as well as in 8-ounce fruit mixes. The product was shipped to… read more
Metal Pieces Prompt Pepperidge Farm Recall
Pepperidge Farm, Inc., in cooperation with the U.S. Food and Drug Administration, has announced a recall of some of the company’s Baked Naturals Sesame Sticks product after reports suggested small pieces of wire may be present, according to recent news sources. The Food and Drug Administration has heard from a few customers who received minor… read more
FDA Announces Safety Review, Re-labeling of Ondansetron Drug
The Food and Drug Administration has announced a safety review of the drug ondansetron, an anti-nausea medication, often prescribed to patients of chemotherapy, radiation therapy, and those who have undergone recent surgery. Studies indicate that ondansetron can increase the chances of prolongation of the QT interval of the electrocardiogram, which can lead to irregular heart… read more
Salmonella Contamination Prompts Herb Recall
Sanith Ourn Farm, based in Florida, has recalled their product Fresh Hot Basil herb due to a salmonella contamination fear, according to news reports. The herb was distributed to retailers in Washington, Oregon, and Rhode Island on August 23rd and 30th. Three hundred and ninety pounds were shipped in ten pound containers that are marked… read more
FDA Develops New Programs to Decrease Food Contamination
The Food and Drug Administration has announced new programs to help identify the source of foodbourne illnesses in processed foods and raw fruits and vegetables, according to news sources. The two programs will implement more thorough records kept by the food distribution and production companies. The FDA hopes to simplify the process that occurs after… read more
FDA Recommends Against Anti Blood Clotting Drug
A negative review from the Food and Drug Administration recommends against Xarelto, an anti blood clotting drug used to prevent strokes in those with atrial fibrillation, according to news sources. Atrial fibrillantion is a heart-rhythm disorder that increases one’s chance of a stroke. According to the staff review of the drug released by Bayer and… read more
Gluten-Free Products Under Stricter Regulation
The Food and Drug Administration is considering adopting stricter standards for foods that can be labeled “gluten-free”, according to news sources. The agency has proposed that foods with the “gluten-free” label cannot contain more than 20 parts per million or more gluten. The issue was last looked at in 2007. The FDA has decided to… read more
FDA Warns of Eye Infection Risk From Avastin Injections
In a news release Tuesday, the U.S. Food and Drug Administration warned healthcare providers of a Miami, Fla.-area cluster of eye infections stemming from repackaged intravitreal injections of Avastin (bevacizumab). The injections tainted with Streptococcus endophthalmitis reached a least 12 patients in three clinics. All of the patients had visual deficits prior to being administered… read more
Report of Strangulation Death Spurs Shoulder Massager Recall
In a news release Wednesday, King International LLC, in cooperation with the U.S. Food and Drug Administration, announced a voluntary recall of a self-massage device amid reports of a strangulation death stemming from the device’s use. Subject to recall are approximately 12,000 Shoulderflex massagers sold between 2003 and 2001. The massage devices were sold nationwide… read more
Undeclared Eggs Prompts Frozen Yogurt Mix Recall
In a news release Tuesday, YoCream International, Inc. announced the recall of one of its frozen yogurt mix flavors due to an undeclared allergen, namely eggs. Subject to recall, with the knowledge of the U.S. Food and Drug Administration, is YoCream’s NY Cheesecake Frozen Yogurt Mix. Individuals who have an allergy or severe sensitivity to… read more