Posted on 03/26/2010 11:27:04 PM PDT by neverdem
Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack.
But the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration.
And many doctors, who discovered only last week that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.
“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” said Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic. If patients with angina took substandard or ineffective nitroglycerin tablets, Dr. Lever said, their pain might not subside and the problem could potentially progress to a heart attack.
The F.D.A., which in recent years has been cracking down on a decades-old backlog of unapproved drugs, sent warning letters last week to two drug makers ordering them to stop marketing unapproved nitroglycerin tablets. But the drugs are still being sold at pharmacies while the order takes effect.
The drug makers said they would comply with the order, but said that their tablets were safe.
The F.D.A. said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past. The agency advised people who take unapproved nitroglycerin to continue taking their tablets but to consult their doctors about replacement prescriptions.
Cardiologists regularly prescribe nitroglycerin to relieve chest pain associated with coronary artery disease. Placed under the tongue, the drug quickly dissolves into the blood, where it dilates the coronary...
(Excerpt) Read more at nytimes.com ...
While not “approved,” I wonder if they still tested OK.
Simple chemical assays are not good enough. When I worked as a chemist, I heard about their requirements indirectly. The company had been thinking about a venture that would involve FDA's OK. When they found out what compliance with FDA's Good Manufacturing Practices(GMP) would require, they said forget about it.
You cannot stock up on them either as they have an expiration date...I know, I take them for unstable angina...FDA should keep the hell off my NTG. so far they work fine........
The pharmacist gave me a red cardboard tube and told me to chew off a piece of it if needed. The sawdust is awful!
(g)
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