Philadelphia Dangerous Drugs Attorneys
The drug Valsartan—prescribed for high blood pressure and heart failure—can
come with serious known and acknowledged side effects, including the following:
- High levels of potassium in the blood
- Intense abdominal pain
- Virus-caused infection
- Joint pain
- Kidney disease with a reduction in kidney function
- Acute infection of the sinus, throat or nose
- Nausea and vertigo
- Appetite loss
- Total lack of energy
- Inflammation of the pancreas
- Inflammation of blood vessels
- Abnormal liver function
- Decreased blood platelets and white blood cells
- Chest pain
- Trouble breathing
Now there is a much larger issue related to the drug.
Media reports have confirmed that several drugs containing Valsartan (typically
used to treat heart failure and high blood pressure) were recalled as
a result of an “impurity” in the drug which can potentially
increase the patient’s risk of cancer. The impurity is N-nitrosodimethylamine
(NDMA) and is classified as a probable human carcinogen.
Manufacturers Teva Pharmaceuticals, Solco Healthcare and Major Pharmaceuticals
have all recalled their prescription drugs containing Valsartan. According to a spokesperson for the FDA, the presence of NDMA in Valsartan
was “unexpected,” and believed to be related to changes in
the manufacturing process. The actions on the part of the FDA came after
22 other countries issued Valsartan recalls. Patients in the United States
who routinely took Valsartan, are now uncertain about their treatment.
Not All Valsartan Drugs Recalled
It is important to note that not all drugs which contain Valsartan were
recalled, because not all Valsartan drugs contained the NDMA impurity.
In particular, the prescription drug Entresto which is manufactured by
Novartis for heart failure does contain Valsartan; however, is not part
of the recall. In fact, no Sandoz or Novartis Valsartan prescription drugs
are included in the current recall. The valsartan products from these
manufacturers do no come from the same source as the other products—which
were affected outside the United States.
How Serious is the Valsartan Cancer Risk?
Currently, the long-term cancer risks of NDMA found in some Valsartan products
is unknown; however, the amount of NDMA would likely make a difference.
The “impurity” found in some Valsartan products is considered
a toxin which can potentially affect the liver—when studies of rats
were done, liver fibrosis, scarring and liver tumors resulted. Those who
have taken the Valsartan with NDMA will likely be dismayed to know that
NDMA is an organic chemical which is typically used to make lubricants,
softeners and liquid rocket fuel. NDMA can also be unintentionally produced
through some chemical reactions and is a byproduct of fish processing
and rubber tire manufacturing.
Recalled Valsartan from China?
Fiercepharma.com reports that the Valsartan in question was manufactured in China—China’s
Zhejiang Huahai Pharmaceuticals voluntarily informed the European Medicines
Agency that NDMA had been found in the Valsartan supplied to the European
market. Huahai Pharmaceuticals claims there have been no restrictions
placed on NDMA; however, in the interest of public health, all unshipped
batches of the Valsartan have been sealed, and all customers and regulators
notified. Huahai Pharmaceuticals was among the first Chinese pharmaceutical
company to get a drug approved in the United States. Huahai claims its
other products have not been affected by the Valsartan issue because of
a different manufacturing process. Huahai sold more than $50 million dollars
of the toxic ingredient in 2017 alone, however after the recall, Huahai’s
stock prices dropped more than 20 percent.
FDA’s Stance on Valsartan Recall
Health care professionals and patients taking the recalled Valsartan products
are currently being alerted about the potential risks of the drug, according to the
FDA. The agency is currently reviewing the issue, investigating the levels
of NDMA in the recalled Valsartan products and attempting to determine
the level of risk among patients who have taken the tainted valsartan
products. Since Valsartan is used to treat serious medical issues, patients
are advised to continue taking their medications until their doctor can
prescribe a replacement. If you have experienced medical issues while
taking a Valsartan product which you now know contains NDMA, it could
be beneficial for you to speak to an experienced product liability attorney
to determine whether you should file a claim. If you are unsure, we have
a list of manufacturers and lot information to tell whether the Valsartan
you used was effected.
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 confidentia
The national product liability lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania; New Jersey, and
throughout the United States.