Doctors Discover Millions of Patients Got Heart Pills Unapproved by F.D.A.

In a recent article from the New York Times that our Washington D.C. Pharmacy Error Injury Attorneys have been following, U.S. doctors who have written over four million nitroglycerin tablet prescriptions, the drugs frequently used to reduce chest pain and stop heart attacks, have recently discovered that a large percentage of the drugs that have been sold to patients have not been approved by the Food and Drug Administration (F.D.A.) for sale, safety, or effectiveness.

According to the article, many doctors have recently discovered that their patients were given unapproved heart medication tablets, and they are unable to know whether the patients have experienced suffering, or any unnecessary personal injury as a result of the unapproved drugs. Dr. Harry M. Lever from the Cleveland Clinic claimed that if angina patients took nitroglycerin tablets that were possibly ineffective or substandard, they may not experience a diminishing of the pain, and the heart problem could lead to a heart attack, or wrongful death.

Nitroglycerin is regularly prescribed for relieving chest pain that comes with coronary artery disease. When the tablet is placed under the tongue, the medicine dissolves into the bloodstream quickly and dilates the coronary artery, which can decrease blood pressure slightly and reduce the heart’s exertion. When patients take nitroglycerin at the first signs of chest pain, cardiologists claim that heart attacks can be prevented.

The F.D.A. sent letters last week to two major nitroglycerin drug makers, Konec Inc., and Glenmark Generics Inc., warning them that they must stop selling the unapproved drugs. Although the F.D.A. claims that it has not examined the quality of the unapproved nitroglycerin products in question, it does have documented problems of other nitroglycerin products in the past.

The article claims that the problem of the unapproved tablets of nitroglycerin comes from the quandary of how to classify drugs whose usage predates the 1938 beginning of the F.D.A. The only tablet brand that has been approved by the F.D.A is Pfizer’s Nitrostat, which was approved in 2000. The research firm IMS Health reportedly found last year that in almost 4.4 million prescriptions for nitroglycerin tablets, nearly 80 percent of the prescriptions were filled with drugs that were not approved.

The F.D.A. letters to the two drug makers gave them 90 days to discontinue making the drugs, 180 days to stop the drug shipping, and six months to continue marketing their unapproved tablets. The letter was not reportedly asking for a recall—in which the company would be forced to remove the product from the market.

Pfizer has reportedly increased production of their drug Nitrostat, after selling over 900,000 prescriptions last year, and claims to have the capability to meet the U.S. market demand of the tablet.

People with ongoing nitroglycerin prescriptions are advised by the F.D.A. to continue taking their medications, but to discuss replacement prescription options with their doctors to avoid pharmacy error, or any potential for a medical mistake, or personal injury.

F.D.A. Says Millions Got Unapproved Heart Pills, The New York Times, March 26, 2010

Related Web Resources:

U.S. Food and Drug Administration: (FDA)

IMS Health

Institute of Medicine, (IOM)

National Coordinating Council for Medication Error Reporting and Prevention, (NCCMERP)

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