The U.S. Food and Drug Administration has twice expanded its recall of several drug products containing the active ingredient Valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.
The reason for the recall is the presence of N-nitrosodimethylamine (NDMA).
NDMA was found in the batches that contained the valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.
NDMA is classified as a probable human carcinogen.
The presence of NDMA was unexpected, said the FDA, and is possibly related to changes in how the active substance was manufactured. According to the EPA, NDMA — which was formerly used in rocket fuel, among other things — can be an unintended byproduct of wastewater treatment plants that use chemical compounds called chloramines for disinfection.
Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
The FDA will continue to investigate this issue and provide additional information when it becomes available.
The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
You can see a list of the recalled medications, as well as a list of products containing valsartan that have not been recalled, on the FDA’s website. Only products contaminated with NDMA are being recalled — not all valsartan tablets.
Not all valsartan products contain NDMA.
Valsartan is used for the treatment of hypertension (high blood pressure) and for the treatment of heart failure. It is also indicated as a treatment for left ventricular failure and left ventricular dysfunction following myocardial infarction. In combination with hydrochlorothiazide, it is used in the treatment of hypertension.
If you are taking valsartan, you should continue taking the medicine until you can determine if you need a replacement product. You can do this by checking the list of affected companies and batches on the FDA’s website.
The risk of stopping treatment can be more harmful to your health than taking the contaminated valsartan for just a bit longer, until you can get it replaced.
Contact your Doctor or Pharmacist. You may get a prescription for a different medication that treats the same indications, or a refill of valsartan medication from a batch that was not affected by the recall.
CBS News has a segment playing on the valsartan recall.
Customers and patients with Medical-related Questions, information about an Adverse Event or other questions about the Teva product’s being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, option 4, then option 1.
- Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to Teva directly at 888- 838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm
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