The FDA has ordered more than 500 common prescription drugs pulled from the market over concerns that they may contain ingredients that are not proven to be safe and effective, and because they may cause harm to children under two. The drug recall affects cough, cold and allergy drugs that have been marketed to both adults and children for years, including industry standards such as Accuhist, Duravent and Rondec, which are often prescribed for asthma.
The problem is that FDA simply does not know whether these prescription drugs are safe. The 500 or more drugs were grandfathered in for approval before changes were made to the FDA approval process that would have required more extensive evidence about their safety and efficacy.
"We don't know what they are, whether they work properly, or how they are made," said Deborah M. Autor, director of the FDA's Office of Compliance at the Center for Drug Evaluation and Research told reporters during a teleconference.
The FDA does not think the patient safety risk is high. Most of the known side effects of the drugs are relatively mild. However, especially for children under the age of two, some of the drugs may actually make their illnesses worse.
FDA's drug recall considered 'long overdue,' especially as regards young children
One concern the FDA expressed about some of the affected drugs is that they are labeled "time-release." However, such drugs require a complex manufacturing process, and the FDA has never had the opportunity to review whether the drugs' active ingredients are actually released in a consistent manner over time.
Another concern involves the combination of ingredients in some products. Otherwise non-dangerous drugs can cause harm when they are combined, and the FDA found that some of the products contain "irrational" combinations, such as two or more antihistamines in the same product.
A third concern is that some of the drugs, such as pediatric cough syrups, are labeled for use in young children, even though their ingredients are the same as over-the-counter drugs that the FDA prohibits for use in children younger than two.
"The new FDA decision supports modern-day pediatric practice to avoid cough syrups in children under 2 because they do more harm than good," said Dr. Yolandra Hancock, a pediatrician at Children's National Medical Center in Washington, D.C.
Cough syrups slow down breathing and can decrease the cough enough that mucus is allowed to build up in the chest, which can cause lung infections in young children.
"[The FDA's move]...is highly appropriate and long overdue," said Hancock.
The FDA recently cracked down on the use of over-the-counter cough and cold medicine in young children. As a result, emergency room visits by children injured by the drugs dropped by 50 percent. Still, 15 percent of the reported injuries that led to the crackdown involved prescription cough and cold medications.
Many doctors may be unaware of the dangers, the FDA says, because the drugs have been in use for years and are listed in the Physicians' Desk Reference.
The federal agency has asked manufacturers to stop manufacturing the drugs within 90 days, and stop shipping them to stores within 180 days. Some manufacturers, however, have already stopped manufacturing and shipping the drugs out of product liability concerns.
A full list of these medicines can be found on the FDA's website.