On June 16, 2009, the FDA issued a press release and warning letter advising consumers to stop using three products marketed over-the-counter by Matrixx Initiatives as cold remedies because they are associated with the loss of sense of smell (anosmia):  Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

The FDA reported that it had received more than 130 complaints and reports of loss of sense of smell associated with the use of these three Zicam products.  In these complaint reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) was quoted as saying that “Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,”  and she continued that “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

According to the FDA, people who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional since the loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA warning letter advised Matrix Initiatives to stop marketing these Zicam products without FDA approval.

On August 13, 2009, the FDA issued a press release and notice of recall on its website anouncing that Barr Laboratories, Inc. was initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756.  

The drug is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.

According to the FDA, the product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09.  Only lot 311756 is affected by this recall. 

Customers and patients who have this lot in their possession were instructed by the FDA to cease using the product and return it to their pharmacy/distributor.  Barr Laboratories has not received any adverse events for this product lot.  The FDA has been apprised of this action.