Federal health officials Wednesday announced a crackdown on the sale of prescription cold, cough and allergy products that had never been proved to be safe and effective.
About 500 products that had not been formally evaluated by federal regulators will be removed from the market, the Food and Drug Administration announced. The move is the latest in a series of actions by the agency to stop the sale of a variety of products that were being sold without government authorization.
Although the agency had received some reports of complications from the products, such as irritability and over-sedation, officials said they did not know how widely the products might cause problems or even how commonly the products are used.
“Like a lot of things that are related to unapproved products, the problem is what we do not know,” said Deborah Autor, director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research.
“We do not know if they are safe. We do not know if they are effective. We do not know if they are of adequate quality,” Autor said during a briefing for reporters. “And we believe that poses an untenable risk to consumers.”
Because many of the the products went on the market years ago, before stringent requirements were put into place, many doctors prescribing them might be unaware that they had not been carefully evaluated, she said.
Among the concerns are that some of the products, which contain 27 different ingredients, are labeled for use by infants and young children, Autor said. In 2008, the agency issued an advisory warning against the use of over-the-counter cough and cold products for infants and children under age 2 because of serious, potentially life-threatening side effects.
Officials are also concerned because some of the products are supposed to be time-released to prevent delivering too high or too low a dose. Some products that are supposed to release sedating antihistamines, for example, over eight to 12 hours actually delivered their full dose within 30 minutes, Autor said.
“We are very concerned,” she said.
Companies making the affected products must stop manufacturing them within 90 days and stop shipping the products within 180 days, the agency said. The FDA lists the products on its Web site, www.fda.gov.
Officials were confident that consumers could get whatever relief they needed from coughs, colds and allergies by using the many over-the-counter and prescription products that had been vetted by the agency, Autor said.
“There are a lot of products available,” she said.