Many patients taking popular blood pressure medications containing valsartan, including Aurobindo valsartan, have been subjected to numerous recalls since contamination with NDEA and NDMA was found in international plants.
Overseas plants that manufacture medication sent to the U.S. still must comply with U.S. Food and Drug Administration (FDA) rules and updates in the manufacturing process must be provided to the FDA in a timely manner.
While the risk of developing cancer from contaminated batches of affected drugs is relatively low, it’s still enough of a concern that the medicines have been taken off the market. Full studies have not yet revealed what that cancer risk is, but the FDA believes it is very small.
An investigation of plants in China and further reports from plants in India indicated that NDEA and NDMA are potential carcinogens that were found in many different lots of valsartan and blood pressure drugs containing valsartan. Some of these contaminated lots came from the Aurobindo factory in the Srikakulam district of India.
What Has Aurobindo Said About the Recall?
At the time of the Aurobindo valsartan recall, the company seemed to believe that the problems would be easily fixable, but a recent report indicates this may not be the case.
According to FiercePharma.com, following an inspection of the Aurobindo plant last fall, it received notice from the FDA that the agency “has classified the inspection of the plant ‘Official Action Indicated,’ a label that means inspectors will recommend the agency take regulatory action.”
FDA officials found objectionable conditions at the factory. Despite news of forthcoming regulatory action, Aurobindo does not believe it significantly affect its U.S. business. The company has agreed to work closely with the FDA to resolve the issues noted during the inspection.
How Many Aurobindo Valsartan Tablets Were Recalled?
According to the Pharmacy Times, the FDA reported that Aurobindo Pharma USA was voluntarily recalling around 80 lots of its valsartan HCTZ tablets, valsartan tablets, and amlodipine-valsartan tablets.
Patients are encouraged to review the FDA’s list of recalled valsartan medicines in addition to speaking directly with their doctors about what to do if their Aurobindo manufactured pills are impacted by the call for potential contamination issues. Many companies have made an effort to be proactive in identifying the risk and removing the drugs from shelves.
What Led to The Aurobindo Valsartan Recall?
The impurity identified in the manufacturing process is known as NDEA or N-Nitrosodiethylamine. The FDA refers to this substance as one that occurs naturally in air pollution, some foods, industrial processes, and drinking water. It is a likely human carcinogen which is what prompted the recall. In addition to the increased risk of cancer associated with NDMA, exposure to the contaminant may also result in side effects such as jaundice, nausea, fever, vomiting, abdominal cramps, headache, and dizziness. High levels of NDMA exposure may also result in kidney, liver, and lung damage.
Amazingly, the contaminants in valsartan slipped past regulators. It is unknown how the NDMA valsartan contamination occurred. The valsartan medication may have come into contact with NDMA at some point during the drug manufacturing process, or NDMA may be formed as an impurity during the drug’s synthesis. Until the source of the contamination is found and contained, patients taking valsartan may want to look into alternate medications to manage their conditions.
Have Any Patients Come Forward with Problems Due to The Valsartan Drugs?
According to a company news release at the time of the recall, it had not received any reports of patients suffering adverse or negative effects from medications associated with the recall.
How Can I Tell if My Medicine Was Affected by The Recall?
The FDA website is maintaining an updated list of all recalled valsartan products. Products can be identified by looking for the manufacturer details, product name, lot number or batch details on the bottles. The expiration dates for the Aurobindo valsartan recall are between May 2019 and March 2021.
What Should I Do If I Am Taking A Recalled Drug?
According to CBS News, the FDA is currently recommending that patients who have been prescribed these blood pressure medications continue to take them until they have received a doctor’s insight. It could be dangerous to discontinue use of these medications immediately.
What Other Companies Have Recalled Valsartan Tablets?
Other companies who have participated in similar valsartan recalls include Mylan Pharmaceuticals and Torrent Pharmaceuticals Limited.
Patients who are currently taking the affected valsartan tablets can discuss alternatives with their physicians if it is determined that discontinuing the drug is the best course of action. Some consumers have filed lawsuits over injuries caused by valsartan blood pressure medication. If you suffered harm from contaminated valsartan, a specialized pharmaceutical lawyer can help evaluate whether you have a case.
If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.
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