FDA Orders Drug Companies to Stop Selling Unapproved Heart Tablets

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Sunday, March 28, 2010

FDA Orders Drug Companies to Stop Selling Unapproved Heart Tablets

More than four million prescriptions were filled last year for nitroglycerin tablets that were not approved by the Food and Drug Administration

(FDA). This represents 80% of all under-the-tongue nitroglycerin prescriptions. But the FDA is now demanding that two leading manufacturers of the heart medication stop selling their tablets pending a review by federal regulators.

FDA officials last week informed Konec Inc. and Glenmark Generics Inc. to stop producing nitroglycerin tablets within 90 days, although they can continue to ship them for another six months. The pharmaceutical companies had managed to sell their drugs without FDA approval because they were grandfathered in when the federal agency was established in 1938.

The only nitroglycerin pill currently being sold that have FDA approval is Nitrostat, made by Pfizer.

“Doctors and patients should know that not all drugs on the market are backed by an FDA approval,” said Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research. “This lack of approval undermines the FDA’s efforts to ensure that safe and effective drug products are available to the American public.”

-Noel Brinkerhoff

F.D.A. Says Millions Got Unapproved Heart Pills (by Natasha Singer, New York Times)

FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets (Food and Drug Administration)

Comments

G 14 years ago

I disagree, the cost difference is because the market will pay it.

yobo 14 years ago

This is nothing new. Drugs on the market prior to 1938 are also known as DESI drugs. They haven't gone thru the modern approval process. Are these drugs bad? Not necessarily. They have proven themselves over the years, but w/o FDA approval. When FDA asks that these drugs go thru the approval process many manufacturers balk at this because it's too expensive and we end up with two things.. a shortage of a very impotant drug (sometimes) and a big spike in the price of any drug still on the market. An example, is quinine. Quinine is used for leg cramps and treating malaria. FDA said you need to do studies for leg cramps, no one did, and quinine was removed from the market; you cannot get it for leg cramps. One product was approved fro malaria treatment. By the way, the leg cramp product and the malaria procduct are the same strength. Here's the catch. The old product that could be used for leg cramps AND malaris cost about $0.03 (3 cents) per capsule. The current product approved only for malaria costs about $4.00 per capsule. The cause of this difference? FDA approval.

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FDA Orders Drug Companies to Stop Selling Unapproved Heart Tablets

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