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FDA Cracks Down on Unapproved Antihistamine

June 12, 2006

The Food and Drug Administration has ordered drug companies making cold, cough and allergy medication containing carbinoxamine, an antihistamine, to stop within the next three months. The agency says carbinoxamine is not approved for use in U.S. medicines, and could be a risk to infants and young children.

The FDA said as many as 26 companies currently produce about 120 medicines containing the unapproved substance. Carbinoxamine is approved for use in only two drugs, both made by Mikart, Inc.

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

"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 Acting FDA Commissioner Dr. Andrew von Eschenbach.

"While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA approved. 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."

Many of the unapproved drugs affected by the FDA scrutiny are medicines that were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act.

FDA approval guarantees that a product has been reviewed and will be consistently monitored for safety, effectiveness and adherence with manufacturing quality standards.

"Unapproved drugs may not meet modern standards for safety, effectiveness, quality, and labeling. Clearly this is a problem we intend to fix," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

How could so many unapproved medicines be on the market?

The FDA said health care providers are often unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs 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).

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