The Food and Drug Administration (FDA) recently forced a recall of several
blood pressure and heart medications containing Valsartan after N-nitrosodimethylamine
(NDMA) was found in the drugs. NDMA is a chemical which has been tied
to cancer in lab studies with rats. Valsartan was first developed to treat
heart failure and high blood pressure, then went off patent and started
being used in many medications made by a variety of manufacturers. The
drug is marketed under various brand names including Exforge and Entresto.
Teva markets Valsartan under the name Actavis. It is important to note
that Valsartan from Novartis is not being recalled, because the Valsartan
from Novartis and Sandoz are not manufactured in the Chinese plant.
The Valsartan manufacturers which are affected include Teva Pharmaceuticals,
Major Pharmaceuticals and Solco Healthcare, all of which have recalled
all prescription drugs containing Valsartan. The FDA called the presence of NDMA in Valsartan “unexpected,”
adding that it is believed the specific manufacturing process used in
the Chinese plant was responsible for the NDMA in the Valsartan. If you
are currently taking Valsartan from one of these manufacturers, you may
wonder about your potential cancer risk.
The impurity which was found in the Chinese Valsartan products is considered
a liver-affecting toxin. Studies of NDMA done on rats showed liver tumors,
scarring and liver fibrosis; however, as with all studies done on rats,
the amount of the drug administered to the rodents is typically extremely
high. NDMA is an organic chemical used to make liquid rocket fuel and
is sometimes unintentionally produced as a chemical reaction in rubber
tire manufacturing and fish processing.
What Caused the NDMA in the Recalled Valsartan?
As noted, the presence of NDMA was unexpected, believed to be related to
changes in the way the active substance in the drug was manufactured.
Huahai Pharmaceuticals claims the new way of manufacturing was approved
from “related countries” and that the amount of NDMA detected
in the recalled valsartan was “extremely small.” Even so,
NDMA is classified by the World Health Organization as a “probable
carcinogen.” Drug agencies in Hong Kong, Taiwan and Japan have all
issued recalls of the drug, however the China branch of Novartis says
none of the valsartan-containing products it sells in China are affected,
because their valsartan drugs are not manufactured in China.
The FDA’s Stance on Valsartan
Action from the U.S. FDA came only after 22 other countries recalled Valsartan
made in China. The FDA tells those taking the drug not to stop taking
it until they have spoken to their physician and have been prescribed
an alternate drug. Because Valsartan is prescribed for serious health
issues, it is important to determine first, whether the drug came from
the China manufacturer. Second, know that there are alternatives to Valsartan,
whether that means switching to a different manufacturer, or switching
to another medication in the same class of drugs, known as angiotensin
receptor blockers. Since there are a number of drugs in that category,
patients’ physicians could switch them to another ARB-type medication.
Finally, those taking the recalled Valsartan could be switched to an entirely
different category of blood pressure drug. Your choice will depend on
your specific medical history and your physician’s recommendation.
If you or a loved one feel you have been harmed by the recalled Valsartan,
it is important that you also speak to a knowledgeable attorney who is
skilled in product liability and dangerous drug claims.
To learn more about your legal options or to schedule a free consultation call the
Philadelphia dangerous drug lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill
out our confidential
The national product liability lawyers at Golomb & Honik have successfully
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throughout the United States.