A nitroglycerin tablet is tiny but it brings mighty pain relief to millions of cardiac patients who take it for their chest pain. Now however, it has been reported that some brands of nitroglycerin are not tested by the FDA and thus should not be used.
Many brands of nitroglycerin tablets sold at American pharmacies are not FDA approved. Thus they may not be effective and safe. The only brand of nitroglycerin that is FDA approved is Nitrostat by Pfizer. This is the only brand patients should be taking if they want to ensure that the drug works as it is supposed to in preventing angina (chest pain) and preventing the chest pain from leading into a heart attack.
The New York Times notes that “Of the nearly 4.4 million prescriptions for under-the-tongue nitroglycerin tablets last year in this county, about 80 percent were filled with unapproved drugs.”
Thus if patients have been feeling that their nitroglycerin did not work to soothe their chest pains they may have been right. They may have been taking a non-FDA approved drug that did not have the effectiveness that Nitrostat has.
Konec and Glenmark Generics Manufacture Non-FDA Approved Nitroglycerin
The companies Konec and Glenmark Generics are selling non-FDA approved nitroglycerin tablets. The FDA has sent these companies orders to stop making and selling the untested nitroglycerin tablets.
These non official brands of nitroglycerin have not undergone bioequivalence testing in human. Thus their effectiveness and safety are not assured.
The FDA announced that “The unapproved products may differ from approved nitroglycerin products in some respects, such as formulation and labeling. The FDA has seen significant quality and efficacy problems with some unapproved nitroglycerin products.”
Ask Doctor to Evaluate Prescription
Cardiac patients who take nitroglycerin now need to ask their doctor to evaluate the drug they take. They may wish to switch their prescription to Nitrostat to ensure their nitroglycerin is effective at treating their chest pain.
Many cardiac patients will be upset to discover that the nitroglycerin they have been taking is not FDA approved. While FDA tests are not always adept at catching unknown side effects that may arise in new drugs, it is even more dangerous to take a drug that has not undergone the FDA tests.
Every person who takes a prescription drug should check to see if that particular drug has received FDA approval. Any prescription drug may have risks. It is important to research the drug and gain information about known risks and ensure that the drug went through the FDA testing process.