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.
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.