On behalf of Lancione & Lancione, PLL
If you have been prescribed nitroglycerin tablets for a heart condition, this warning is for you: Not all nitroglycerin prescriptions are equal.
In fact, only one brand of the medication has been approved by the Food and Drug Administration (FDA). The one approved brand of nitroglycerin, Nitrostat, is produced by Pfizer.
The two other main companies that currently manufacture nitroglycerin tablets are Konec Inc. and Glenmark Generics Inc. They have found great success in the sales of their products, 80 percent of the tablets sold last year coming from those companies.
To be FDA approved, Pfizer's tablet has gone through tests that prove the medication's effectiveness to safely produce its intended serious, sometimes life-saving results. Patients with chest pains or experiencing the beginning of a heart attack place the tablet under their tongue in order for the medication to quickly dissolve. The medication enters the bloodstream to reduce heart pain or stop a heart attack.
Taking an alternative form of nitroglycerin, therefore, such as a Konec of Glenmark product, is considered hazardous at this point. The medication treats a serious issue, making it vitally important to take the appropriate form of the drug.
What Now?
The fact that many of their patients have been taking an unapproved drug shocks many doctors who now are uncertain about whether their patients have been harmed due faulty medication. Doctors do not often specify the exact brand of the drugs they prescribe, presuming that the pharmacy will generally only dispense an FDA-approved drug.
Patients-and possibly pharmacists-hastily assume non-Pfizer brands of nitroglycerin are merely the more affordable, generic brands of the drug and therefore do not question its effectiveness. But it is important to know that as of now, only Nitrostat is proven to safely and effectively protect your heart.
That knowledge is important, because Konec's and Glenmark's nitroglycerin tablets have not been recalled.
On March 16, the FDA did demand that the companies stop manufacturing the tablets within 90 days and stop shipping them within 180. Until then, therefore, the unapproved tablets will continue to be sold.
Pending FDA approval, doctors, patients and pharmacists would be responsible by specifying Pfizer's brand, Nitrostat, as the desired prescription to treat heart conditions.
If you are currently taking an alternate brand of the drug do not stop taking it without talking with a physician. Nitroglycerin serves an important medical purpose, and you don't want to risk the adverse effects of going off your medicine.
After all, Konec's and Glenmark's brands could very well be safe and effective medical options. Nonetheless, until that is proven, do not assume a medication is safe just because it is from a pharmacy.
Make an educated choice and you might save your life.
If you believe you have been harmed due to the irresponsible distribution and representation of a prescription drug, do not hesitate to seek the guidance of an experienced personal injury lawyer.
