FDA MedWatch

December 21, 2010

FDA has issued consumer advisories on several products recently, and McNeil Consumer Health Care and Reese Pharmaceutical Co. have issued product recalls.

FDA has issued consumer advisories on several products recently, and McNeil Consumer Health Care and Reese Pharmaceutical Co. have issued product recalls.

Recalls

McNeil, a division of New Brunswick, N.J.-based Johnson & Johnson, has recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews. The products were distributed in the United States, and the recall affects 13 million packages.

In addition to the company announcement, FDA’s Adverse Events Division reported that consumers discovered foreign contaminants - wood and metal particles - in their Rolaids medication.

In its statement, McNeil said a company investigation determined that the contaminating particles were introduced into the medications during the manufacturing process. Production of the product line has been suspended, according to the company, as the investigation continues.

Johnson & Johnson has recalled more than 40 brands of its over-the-counter medications in 2010 because of contamination problems.

In addition, Cleveland-based Reese Pharmaceutical voluntarily recalled 60-count-size bottles of cold decongestant tablets identified as 4 different brand names because the tablets - containing acetaminophen 325 mg, phenylephrine 5 mg, and chlorpheniramine maleate 2 mg - were mislabeled as containing only 200-mg guaifenesin. The mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine, or chlorpheniramine.

The product was distributed nationwide, and FDA is aware of the recall. There have been no reports of adverse events from its use.

Advisories

FDA has issued warnings regarding 2 products, Man Up Now and Vigor-25, both marketed as natural dietary supplements to enhance male sexual performance.

The agency is advising consumers to avoid using Man Up Now capsules, because the product contains a variation of an active drug ingredient found in Viagra (Pfizer) that can dangerously lower blood pressure.

Man Up Now claims to be “herbal” and “all natural,” but an FDA analysis determined that the product contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, sulfoaildenafil may interact with prescription drugs such as nitrates, including nitroglycerin, and cause a dangerous drop in blood pressure, an FDA spokeswoman told Drug Topics.

Man Up Now, distributed by Synergy Distribution LLC, is sold on Internet sites, online marketplaces, and in some retail outlets.

FDA is also cautioning consumers about Vigor-25, which the agency says does contain sildenafil. The agency is investigating the reported death of a 26-year-old man, possibly associated with the use of Vigor-25.

Vigor-25, distributed by Piston Corp., is sold on Internet sites and possibly in some retail outlets.

“[Vigor-25] is dangerous, because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient,” said Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

Separately, FDA issued information regarding Tessalon (Forest Laboratories Inc.) liquid cough capsules. The agency advises that the product be kept in a child-proof container because it looks like candy and could pose a risk to young children if ingested.

The drug is approved to treat cough symptoms in individuals age 10 and older, but its appearance might entice younger children who could suffer serious side effects or die if they take it, according to FDA.

Tessalon is the brand under which benzonatate is sold. Generic versions are also on the market.

From 1982 through May 2010, there have been 7 cases where children younger than age 10 accidentally ingested benzonatate, according to FDA. Five of those children died.