Unapproved Heart Pills sold to millions
March 29th, 2010 - 8:19 pm ICT by Pen Men At WorkMarch 29, 2010 (Pen Men at Work): In the United States last year, doctors wrote roughly more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce chest pain angina or to stop a heart attack. However, a majority of the drugs that were sold had not been permitted for sale. The Food and Drug Administration (F.D.A.) hadn’t even evaluated their safety and effectiveness.
It was only last week that a majority of the doctors discovered that pharmacies had been giving unapproved heart tablets to the patients. The doctors state that they have no way of knowing if their patients suffered unnecessarily as a result of it.
According to Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic, the doctors cannot be sure if the medication is safe or not unless it has been approved and tested. He states that if patients with angina have taken poor quality or futile nitroglycerin tablets, their pain wouldn’t subside and the problem could then bloom into a heart attack.
Two drug makers were sent warning letters last week by the F.D.A. which ordered them to stop selling unapproved nitroglycerin tablets. However, until the order takes effect, the drugs continue to be sold at pharmacies. According to the drug manufacturers, their tablets were safe but they would still comply with the order.
The quality of the products it had ordered off the market hadn’t been examined by the F.D.A. but it had recorded problems that occurred as a result of unapproved nitroglycerin products in the past. Patients were advised to continue taking the nitroglycerin tablets but to consult their doctors for replacement prescriptions.
Nitroglycerin is prescribed by cardiologists to patients suffering from chest pain, associated with coronary artery disease. The drug dissolves into the blood as soon as it is placed under the tongue and dilates the coronary artery, slightly decreasing blood pressure and reducing heart exertion.
According to Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, nitroglycerin can prevent a heart attack in 3 to 4 percent of patients if taken during an initial episode of chest pain.
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