Continuing a crackdown on ineffective prescription drugs, the Food and Drug Administration has ordered pharmaceutical companies to pull about 500 unapproved cough, cold and allergy products from the U.S. market.
Many of the medicines have been on the market since before 1962, when Congress started requiring the FDA to scrutinize drugs for safety and effectiveness before they could go on sale. The withdrawal of the grandfathered drugs “will reduce potential risks to consumers,” FDA official Deborah Autor said in a news release.
The drugs include products such as Cardec, Lodrane, Organidin and Pediahist. The crackdown is the largest in a series of withdrawals the FDA has ordered since 2006 as part of its Unapproved Drugs Initiative.
The FDA, which does not recommend cold medicines for children under age 2, said in a regulatory notice that it is “particularly concerned” about unapproved products being labeled for pediatric use. It also has concerns that some products have potentially risky combinations of ingredients, while others — marketed as “timed-release” — may release active ingredients too slowly, too quickly or inconsistently.
“We don’t know what’s in them, whether they work properly, or how they are made,” Autor said.
She also said that many physicians are unaware that these products are unapproved, especially since they are listed in the Physicians Desk Reference drug guide and may be advertised in journals or brought into doctors’ offices by pharmaceutical sales representatives.
As The Washington Post reports, although the agency has received reports of complications from the products, such as irritability and over-sedation, officials said they did not know how frequently problems occur or even how widely used the drugs are.
FDA officials, though, said they expect “little or no negative impact” from the withdrawal of the products, citing the wealth of agency-approved prescription drugs, as well as over-the-counter remedies, to treat cough, cold and allergy symptoms.
