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FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
Date:3/2/2011

saw a business opportunity."

According to the FDA, many doctors prescribe these drugs because they aren't aware they have not been approved. Most of these drugs are listed in the Physicians' Desk Reference (PDR), which is a guide doctors can use when prescribing drugs, Autor noted.

FDA officials expect companies that have listed products with the agency to stop making them within 90 days, and to stop shipping them within 180 days. The agency pointed out that this action will not affect patients since there are many approved prescription and OTC cough, cold, and allergy medications already on the market.

One group representing cold and allergy experts sought to clarify the move for consumers.

"In light of the FDA announcement, it is important to make a distinction between these unapproved drugs and the individual components within the drugs," Dr. Thomas B. Casale, executive vice president of the American Academy of Allergy, Asthma & Immunology, said in a statement released Wednesday.

"Many of the components can be obtained over-the-counter or by prescription and are approved by the FDA," Casale said. "However, the listed drugs for removal have not proven safe and effective by adequately approved FDA studies. Furthermore, some combination of the components contained in these drugs could result in adverse effects."

And one doctor warned of the dangers of drug combinations.

"I am amazed at the number of prescription products on this list, and 95 percent of them Ive never seen before," said Dr. E. Neil Schachter, a professor of medicine at The Mount Sinai School of Medicine in New York City. "My approach to treating colds and flu is to give specific ingredients for symptom relief separately and not in a combination form. Too often people will buy multiple cold products and don't realize they are taking the same ingredients more than once and are risking an overdose."

There's a long list of the drugs in question at the
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