Skip to Content

FDA Acts to Improve Drug Safety and Quality

FDA Strengthens its Efforts on Unapproved Prescription Drug Products Containing Carbinoxamine

The Food and Drug Administration (FDA) announced the strengthening of its efforts against unapproved drug products. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children under 2 years of age.

The agency is issuing a final guidance document outlining its approach to addressing other medicines that are marketed without FDA approval.

The first action under the new guidance, "Marketed Unapproved Drugs--Compliance Policy Guide," concerns carbinoxamine-containing products. Carbinoxamine-containing products require FDA approval to be marketed, but numerous products containing carbinoxamine, either alone or in combination with other active ingredients, are marketed without FDA approval. To date, FDA has approved two carbinoxamine products for various allergic symptoms. Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, an indication for which carbinoxamine has not been found safe and effective by FDA. Many companies are selling carbinoxamine drops and syrups that are specifically labeled for use in children as young as one month of age. Carbinoxamine has never been studied in very young children, and FDA cannot predict how they will respond to it. However, children under 2 years of age are more susceptible to drug-related adverse events, in part due to the immaturity of their systems.

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 today's final guidance, including the antihistamine carbinoxamine, 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.

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).

Under the guidance issued today, FDA is encouraging companies to comply with the drug approval process and seek approval for their products, as well as safeguarding consumer access to important medicines. The guidance identifies as the highest priority for agency enforcement action those unapproved products that are most likely to pose a risk to public health. The guidance explains that FDA intends to continue to give priority to enforcement actions involving unapproved drugs (1) with potential safety risks, (2) that lack evidence of effectiveness, and (3) that constitute health fraud. It also explains how the agency intends to address those situations in which a company obtains FDA approval to sell a drug that other companies have long been selling without FDA approval. Those manufacturers that do not comply with drug approval requirements may be subject to enforcement action.

Today's actions are part of FDA's broader initiative, launched last year, to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs.

The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling. It is noted that some unapproved drugs may provide benefits. However, since these unapproved drugs are not approved by the FDA, the agency recommends that patients and health care professionals carefully consider the medical condition being treated, the patient's previous response to the drug, and the availability of approved alternatives for treatment.

Posted: June 2006