FDA Orders Unapproved Cold Remedies Pulled From Shelves

ROCKVILLE, Md. June 9 ? In the opening salvo of an FDA initiative to cleanse the market of unapproved drugs, the agency has ordered some 120 cough and cold medicines that contain carbinomoxamine off store shelves.

The two approved carbinomoxamine-containing products can continue to be sold legally, the agency said.

The FDA said there is no evidence that carbinoxamine is safe for children under age two, yet dozes of cough drops and syrups marketed for infants and toddlers contain the compound. Twenty-one deaths have been reported among children under age two who took carbinoxamine products, agency said.

At a news briefing, FDA attorney Deborah Autor, the associate director of the Office of Compliance of the Center for Drug Evaluation and Research, said Mikart, Inc. of Atlanta, makes the only FDA-approved carbinoxamine products: a tablet marketed as Palgic Carbinoxamine Maleate (4 mg) and an oral solution sold as Palgic Cardinoxamine Maleate Oral Solution (4mg/5ml) and Carbinox Maleast Solution (4 mg/5ml).

She cited in no particular order unapproved products such as Rondec, Cardec and Histex. Rondec has a number of formulations including oral drops that are recommended for use in infants (six to 12 months, recommended dose 0.75 mL q.i.d.) and young children (Rondec syrup 1.25 mL q.i.d. recommended dose for children two to six years.)

Alliant Pharmaceuticals, which makes Rondec pediatric products in two flavors-bubblegum and grape-responded to the FDA announcement by pointing out that it had reformulated its product in December 2004 so that it no longer contains carbinoxamine. A check of the Alliant website indicated that the Rondec drops and syrup contain chrolpheniramine maleate, phenylephrine hydrochloride, and dextromethorphan.

The FDA move to stop sales of unapproved carboninoxamine products is the first action under the new guidance, called Marketed Unapproved Drugs--Compliance Policy Guide.

"Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Andrew von Eschenbach, M.D. the Acting Commissioner of Food and Drugs.

The FDA said it estimates that there are several hundred different unapproved active ingredients in prescription drugs on the market. The agency estimates that less than 2%t of prescribed drugs are unapproved.

Most the unapproved agents have been marketed below the FDA's radar because they predate the current FDA drug-approval process. "These unapproved drugs have bypassed the agency approval process through which FDA ensures, based on reliable scientific data, that marketed drugs are safe, effective, properly manufactured, and accurately labeled," the agency said.

Moreover, physicians are unlikely to be aware of this unapproved status, the FDA said, because the "drugs' labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians' Desk Reference (PDR)."

Autor said unapproved carbinoxamine-containing products have 30 to 90 days to stop clear the shelves. Manufacturers who fail to meet this deadline will be subject to additional FDA actions including sanctions and fines, she said.