Unapproved Prescription Drugs Prompt FDA Crackdown

Agency Orders Removal of 500 Cough, Cold, Allergy Meds

March 02, 2011 05:10 pm David Mitchell

Family physicians and other health care professionals may be surprised to learn they have been prescribing medications -- perhaps for years -- that have not been approved by the FDA. The agency took action today to stop such drugs from being dispensed to patients, ordering manufacturers to remove about 500 cough, cold and allergy products(www.fda.gov) from the market.

"This action is necessary to protect consumers from the potential risks posed by unapproved drugs because we don't know what's in them, whether they work properly or how they were made," said Deborah Autor, J.D., director of the office of compliance in the FDA's Center for Drug Evaluation and Research, during a news conference.

When the Federal Food, Drug, and Cosmetic Act was enacted in 1938, new drugs were required to be reviewed by the FDA for safety. The law was amended in 1962, requiring that new drugs be proven effective for their labeled indication, as well as safe. The amendment also required that thousands of drugs approved as safe between 1938 and 1962 be evaluated for effectiveness.

However, Autor said some products remained on the market illegally, and others have since entered the market illegally. Some of the more common brand-name products affected are Cardec, Lodrane 24D and Organidin, she said.

According to Autor, physicians' confusion about the issue has been exacerbated by the fact that some of the unapproved drugs are marketed in medical journals and listed in the Physicians' Desk Reference.

"Most family docs, at some point, have prescribed some of these medications," said Carrie Nelson, M.D., of Wheaton, Ill., who is chair of the AAFP's Commission on Health of the Public and Science. "We've generally assumed them to be FDA-approved, not recognizing they came on the market before the more strict guidelines for FDA approval."

The FDA said it was particularly concerned about two types of unapproved cough, cold and allergy medications, namely

  • products with pediatric labeling, including some marketed for use in children as young as 1 month old; and
  • extended-release products.

Unapproved extended-release products could put patients at risk by releasing their active ingredients too quickly, Autor said. Alternately, the products could release their medication too slowly or not at all.

Also of particular concern are products with "irrational" combinations of ingredients, she added, including medications that contain multiple antihistamines.

OTC cough, cold and allergy products are not affected by today's FDA's action. Autor said products that are in compliance with an OTC monograph have been proven safe and effective. She also noted that patients should not be adversely affected by the removal of the unapproved prescription products because prescription and OTC alternatives are available.

Still, patients may need some convincing.

"Sometimes patients feel better getting a prescription," said Nelson, who also is medical director of the Illinois Medicaid program, Your Healthcare Plus. "You're trying to minimize the use of antibiotics for viral respiratory symptoms, so you instead prescribe a cough and cold medication. Patients often feel there's something more effective about a prescription than something sold over the counter, though that's not necessarily the case."

But, said Nelson, physicians and their patients should instead rely more on OTC medications for coughs, colds and allergies, and physicians should reinforce the fact that those products have been proven safe.

Today's action is the 17th in less than five years since the FDA launched its Unapproved Drugs Initiative(www.fda.gov), which aims to bring all unapproved drugs into the agency's approval process.

The FDA requires manufacturers to list their products with the agency, whether or not those products have received approval. Autor said companies that previously listed products subject to today's action must stop manufacturing them within 90 days and stop shipping within 180 days. Companies with unlisted unapproved products were ordered to stop manufacturing and shipping immediately.

Health care professionals are encouraged to report adverse side effects from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch program(www.fda.gov).