FDA News: November in Review

11/01: FDA Warns that Potiga Can Cause Skin Discoloration & Eye Abnormalities

In November, the FDA issued a warning to the public stating that Potiga (an anti-seizure medication) could cause blue skin discoloration and eye abnormalities. The FDA and the manufacturer are currently working together to gather information about these events to determine if the changes are reversible. Since the announcement, the FDA has approved changes to the drug's label to prominently state these risks. The FDA has advised that the use of Potiga should be limited to patients who have not responded to other therapies.

11/04: Janssen Pharmaceuticals Pleads Guilty

The U.S. Department of Justice announced a plea agreement with Janssen Pharmaceuticals, Inc. (JPI) on behalf of the FDA in early November regarding Risperdal (risperidone). Per the announcement, JPI agreed to pay more than $1.6 billion in a combination of criminal pleas and civil settlements to resolve allegations that they had misbranded the drug and made false claims. The U.S. Department of Justice also alleged that JPI and Johnson & Johnson knew about the serious risks of Risperdal but significantly downplayed them.

11/07: FDA Warns About Iclusig Causing Serious Blood Clots

In late October, Ariad Pharmaceuticals agreed to suspend marketing and sales of Iclusig, a leukemia chemotherapy drug. The FDA is investigating the frequency with which patients report serious blood clots in arteries and veins after taking the drug, as clinical trials seem to corroborate reports of serious adverse events. Side effects include heart attacks, worsened coronary artery disease, stroke, and the narrowing of arteries and blood vessels.

11/08: Voluntary Recall of Nutritional Shakes & Performance Protein Product

In early November, Sequel Naturals Inc. ("Vega") announced a voluntarily recall of a few of their products—namely, the Vega One Nutritional Shake and Sports Performance Protein products. Per the announcement, the products were withdrawn due to trace amounts of chloramphenicol (CAP). While CAP is a naturally occurring antibiotic, it should only be used with medical supervision.

11/09: OxyElite Pro Dietary Supplement Recalled

USPlabs LLC recently recalled all lots and sizes of their OxyElite Pro dietary supplement products as they were found to contain Aegeline. Evidence shows that the use of these products can lead to serious adverse side effects, such as liver damage or complete liver failure. The product was distributed nationwide.

11/13: Voluntary Recall Due to Lack of Sterility Assurance

Nature's Pharmacy and Compounding Center announced they were going to voluntarily recall all of their sterile products (injectable drugs and eye drops) due to safety concerns about quality control procedures. The company is concerned that the sterile products may have been compromised, which could lead to serious infections for patients. Per the announcement, the products were all distributed within North Carolina.

11/13: Undeclared Active Ingredient Leads to Voluntary Nationwide Recall

Vitality Research Lab has issued a voluntary recall of lots K58Q and F50Q of its product VitaliKOR Fast Acting, which has been marketed as a dietary supplement. FDA laboratory analysis found the lots contained both Vardenafil and Tadalafil, which are FDA-approved drugs used to treat erectile dysfunction. These undeclared active ingredients could interact with prescription drugs to dangerously lower blood pressure.

11/16: Dietary Supplement Drug Voluntarily Recalled

On November 16, Jobbers Wholesale announced a recall of certain lots of Rhino 5 Plus, Maxtremezen, and Extenzone—all of which are marketed as dietary supplements. These products were found to contain undeclared drugs, namely desmethylcarbondenafil and dapoxetine. Desmethylcarbondenafil is used to treat erectile dysfunction and could adversely interact with some patient's prescription drugs; dapoxetine is not approved by the FDA and has therefore not been established as a safe drug to consume.

11/20: FDA Warns About Serious Risk of Heart Attack & Death

The FDA has issued a warning to health care professionals regarding the use of Lexiscan and Adenosca, which have been linked to a risk of serious heart attack and death. Both Lexiscan and Adenosca are used during cardiac nuclear stress tests to identify coronary artery disease. The use of the drug causes blood to flow to the healthier arteries, therefore reducing blood blow to obstructed arteries; this can lead to heart attacks. The FDA has approved changes to the drug label that properly reflect the risk of these serious side effects.

11/27: Baxter International Voluntary Recalls Dextrose Injection

Baxter International Inc. recently announced a voluntarily recall of one lot of Nitroglycerin in 5% Dextrose Injections because of particulate matter found in a vial. If that particulate matter was injected, it could block blood vessels, as well as cause adverse side effects such as inflammation.

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