FDA Launches Heart Drug Irbesartan Recall Due To Cancer Risk
The FDA is issuing an irbesartan recall after discovering this high blood pressure medication is contaminated by the cancer-causing chemical N-nitrosodiethylamine (NDEA). This is the second heart medication recalled this year because of NDEA contamination.
Patients use irbesartan alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of stroke and heart attacks.
Irbesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, irbesartan relaxes the blood vessels. Then, this lowers blood pressure and increases the supply of blood and oxygen to the heart.
When the FDA tested irbesartan, the agency discovered it contained N-Nitrosodiethylamine or NDEA. NDEA is a suspected human and animal carcinogen. Gasoline uses the chemical along with industrial materials as a stabilizer. Also, manufacturers need NDEA to produce liquid rocket fuel.
India’s Aurobindo produced the tablets and labeled them as Westminster Pharmaceuticals and Golden State Medical Supply. Consumers should return them to their pharmacies. This is the first non-valsartan drug product that the agency has found to contain NDEA. In July, the FDA recalled valsartan due to the carcinogen and began testings all ARBs for this chemical. In fact, the agency designed a special test for this chemical after learning about the contamination of some ingredients imported from one company in China, Zhejiang Huahai Pharmaceuticals.
Also, the FDA placed Zhejiang Huahai Pharmaceuticals on an import alert at the end of September. This means the agency will not permit all active pharmaceutical products and finished products made by the company to enter the United States. The FDA made that decision after its recent inspection of the facility.
Many people after taking irbesartan are horrified to learn that their medication could have caused their cancer. Therefore, it is important to seek justice. These potentially cancer-causing drugs have been on the market for over 5 years. This is unacceptable. You should hold these manufacturers accountable.
We want to help send a message that this is not acceptable. If a dangerous product harmed you, we will be your advocate. Additionally, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.