Patients who are taking the generic blood pressure medication “valsartan” need to check their prescriptions to see which company is making the drugs. The FDA recently issued a recall of several prescription medications containing valsartan due to the detection of an impurity that has been classified as a probable human carcinogen (a substance that could cause cancer).
Consumers are advised to follow their doctors’ instructions, and to continue taking the medications until they’re able to obtain replacement products. They should also check the drug labels and contact the dispensing pharmacies to find out which company sold the products. Those with recalled medicines should follow the recall instructions provided by the companies. That information can be found on the FDA’s website.
It is believed that changes in the manufacturing process implemented back in 2012 may have introduced the impurity to valsartan. If this proves to be the case, thousands of patients could have been exposed to the potential cancer risk. Our firm is investigating cases in which patients suffered serious injuries because of valsartan.
Why Were Some Valsartan Drugs Recalled?
The Chinese manufacturer, Zhejiang Huahai Pharmaceuticals, makes Valsartan. They detected an impurity called “N-nitrosodimethylamine (NDMA)” in the valsartan supplied to manufacturers in the European Union.
After hearing about this finding, the European Medicines Agency (EMA) stated that they were reviewing those drugs containing valsartan. Rather than wait until the review was completed, however, the EMA took immediate action and recalled all medicines containing valsartan supplied by Zhejiang Huahai. The recall affected about 2,300 batches sent to numerous European countries, including Germany, Finland, Hungary, Austria, Ireland, Italy, Spain, France, and more.
The EMA’s scientists continue to investigate the levels of NDMA in the medicines, and its possible impact on patients taking them. They’re also looking into how they can reduce or eliminate the impurity from the drugs in the future.
In July 2018, the FDA joined the EMA in recalling all medicines sold in the U.S. containing valsartan supplied by Zhejiang Huahai. They noted in their press release that their review, like the EMA’s, was ongoing, and that they will be investigating the level of NDMA in the recalled products and its potential effect on patients.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients,” said FDA Commissioner Scott Gottlieb, M.D., “we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”
Patients should check the labeling on their products, and those that have recalled medicines should contact their doctors for instructions on treatment. There are numerous alternative medications that can be used to treat high blood pressure and heart failure. Patients should also check the FDA’s website for instructions on returning the products.
Types of Injuries Associated with Valsartan
Patients who have taken recalled valsartan medicines for long periods may be at risk for:
- Cancerous tumors
- Liver damage
What is Valsartan?
Valsartan is an oral medication used to:
- treat high blood pressure
- treat congestive heart failure
- reduce risk of heart attack or stroke
- reduce risk of repeat events in patients who have already suffered a heart attack or heart failure
Valsartan belongs to a class of drugs known as “angiotensin receptor blockers (ARBs)” that block the action of the angiotensin converting enzyme (ACE) in the body. This enzyme typically attaches to receptors found in blood vessels, causing them to narrow or constrict. This leads to an increase in blood pressure.
Typically, ACE works to help increase blood pressure when needed, such as when you’re exercising or experiencing a stressful moment. But in people with high blood pressure, the goal is to bring that blood pressure level down. ARBs do just that by blocking the receptors in the blood vessels, thereby preventing them from narrowing or constricting. The result is a more dilated blood vessels, and a lower blood pressure level.
There are many medications that include valsartan, and not all of them are affected by this recall. Diovan and Entresto, for example, both contain valsartan, but have not been affected by the impurity. Only generic versions of the drug made by the following three companies have been recalled:
- Major Pharmaceuticals
- Teva Pharmaceuticals
- Solco Healthcare
What is NDMA?
NDMA is a semivolatile organic chemical that forms as a byproduct in both industrial and natural processes. It’s not commercially produced or used in the U.S. anymore, though it was formerly used to produce liquid rocket fuel, additives for lubricants, and softeners for copolymers. It can, however, be unintentionally produced in and released from other sources during chemical reactions involved in manufacturing, which seems to be what happened with the production of valsartan.
The Environmental Protection Agency (EPA) states that potential sources of NDMA contamination include:
- pesticide manufacturing
- fish processing
- rubber tire manufacturing
- dye manufacturers
- surfactant industries
- chlorination of wastewater
- drinking-water treatment plants that use chloramines for disinfection
As far as its health effects are concerned, it depends on the level of exposure. The EPA states that high levels can cause liver damage in humans, with symptoms including headaches, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, and reduced liver function.
The EPA has also classified NDMA as a probable human carcinogen based on animal studies that showed exposure to the chemical increased risk of tumors. These tumors occurred primarily in the liver, respiratory tract, kidney and blood vessels. The animals were exposed to large quantities of the chemical, however, so the risk in humans is still unknown.
File a Valsartan Lawsuit
If you took high blood pressure medications containing valsartan and you suffered from serious injuries, you may be eligible to file a valsartan lawsuit to recover damages. Our firm is now investigating these cases and invites you to call today at 1-888-480-1123.