The U.S. Food and Drug Administration ordered more than 500 prescription cough, cold and allergy products off the market Wednesday, saying its office had not evaluated the medication for safety, effectiveness and quality.
"Removing these unapproved products from the market will reduce potential risks to consumers," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, in a news release from the agency.
The FDA said removing the products from the market poses no harm to consumers, but taking the unapproved drugs may put the health of people at risk.
"There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products," Autor added.
Among the drugs listed by the FDA is Pediahist, a cold formula labeled for patients as young as 1 month old. FDA regulations do not recommend cold medicines for any children under age 2. Other drugs involved in the recall include Cardec, Lodrane and Organidin.
Many health-care providers are unaware that the drugs are unapproved and have continued to prescribe them to patients, the FDA said. Consumers who are taking an unapproved prescription cough, cold, or allergy product should contact their health-care provider to discuss alternatives.
The FDA said no serious side effects from the drugs have been reported, but some users have complained of drowsiness, sedation and irritability after taking them.
Companies that manufacture these medications must stop making them within 90 days and stop shipping the products within 180 days, the FDA said.
A complete list of the unapproved cough, cold or allergy products can be found here.
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