Valsartan Blood Pressure Medication Recall Sparks Fears of Drug Safety
July 20, 2018
For years people have been concerned about the safety of drugs that are imported to the United States from other countries. With drugs being manufactured so far away, it can be difficult to know that the same regulations manufacturers must adhere to in the U.S. are being followed in other countries. Now, many patients are realizing those fears after the Food and Drug Administration announced a voluntary recall of a drug made in China.
The drug is known as Valsartan and is largely used to help patients suffering from hypertension, or high blood pressure. Recently the FDA discovered that the drug may be contaminated by N-nitrosodimethylamine (NDMA), a substance that may be a human carcinogen. The contamination came after Zhejiang Huahai Pharmaceutical Co., the company that manufacturers the drug, changed the way the drug was made.
While only Zhejiang Huahai Pharmaceutical Co. Ltd., made the drug in China, it is being sold by three different companies in the United States. These companies include Major Pharmaceuticals, Teva Pharmaceutical Industries, Ltd., and Solco Healthcare.
Those names are important, as patients now need to look at their prescription packaging to identify the manufacturer of their drug. If one of those names does appear on the packaging, patients should to speak to their doctor about a replacement drug. There are many other companies that distribute the drug and have not been affected by the recall. If patients cannot find the information, they are advised to take the prescription to the pharmacy that sold them the drug to get the answers they need.
Until patients can get a replacement prescription, they are advised to continue taking the drug. High blood pressure can increase a person’s risk of heart failure, making abstaining from the drug much riskier than taking it at this time.
The FDA has stated that they will continue to investigate the matter, investigating further as to just how much NDMA was in the recalled products and the risk exposure for patients. The FDA has also stated they will try to establish measures that could ensure future batches of the drug are safe for patients to use.
All patients have the right to be kept safe when using products, including medication. The fact that they can be denied this right by manufacturer oversight is the reason so many are hesitant about allowing imported medication into the United States, where it could adversely affect many patients.
With a manufacturer so far away, it not only makes it more difficult to monitor their manufacturing process but holding them responsible can also be more of a challenge. While these arguments have been touted for years by those skeptical of imported drugs, this newest case brings those arguments back to light. And it has critics and patients both worrying once again about the safety of imported drugs.
If you have questions about Valsartan or have suffered a serious side effect after taking Valsartan, legal assistance may be available to you. Please contact a product defect attorney at Domnick Cunningham & Whalen today for a free consultation.