Blood pressure medication recalled for cancer fears
We at Komando.com are all about keeping you and your family safe. From cybersecurity to scams, we try our best to inform you about the latest threats out there.
Some of these threats may not be tech-related but they can endanger you and your loved ones all the same. Some of the most critical updates you need to know about are product recalls since they can put you and your family at risk.
Now, the latest recall is one that you should definitely know about and please pass it along to your family and friends. If you know someone who’s taking medication for high blood pressure, inform them immediately.
Valsartan recall
Medication used for controlling high blood pressure and heart failure prevention were voluntarily recalled this week due to the presence of an unexpected impurity that may lead to cancer.
The affected products have an active ingredient known as valsartan, an off-patent generic drug used for high blood pressure treatment.
How come? Well, the recalled products may have traces of an impurity known as N-nitrosodimethylamine (NDMA), a possible carcinogen.
NDMA is an organic chemical used for a variety of products including liquid rocket fuel and lubricants but research shows that it can cause tumors in the liver, kidney and respiratory tract.
According to the U.S. Department of Health and Human Services, exposure to elevated levels of NDMA can cause liver damage and is a possible human carcinogen.
Affected products
The Food and Drug Administration (FDA) requested three companies, Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. to recall their products containing valsartan.
Solco Healthcare and Teva Pharmaceuticals were also asked to recall their products that contain valsartan/hydrochlorothiazide (HCTZ).
Affected products include the following:
- Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg (expiry dates from Jul 2018 to Jan 2020)
- Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg (expire dates from Jul 2018 to Jan 2020)
Aside from the U.S., 22 other countries have already issued valsartan recalls, as well.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, the FDA’s Center for Drug Evaluation and Research director, in an official statement. “This is why we’ve asked these companies to take immediate action to protect patients.”
Not all valsartan products are affected
Keep in mind that not all valsartan products are being recalled. It’s mainly the products that contain valsartan supplied by a Chinese company called Zhejiang Huahai Pharmaceuticals.
According to the European Medicines Agency, a review was triggered earlier this year after Zhejiang Huahai Pharmaceuticals detected NDMA in the valsartan it produces.
The agency noted that the unexpected presence of NDMA in Zhejiang Huahai’s products may be related to the changes in its valsartan manufacturing process.
What the FDA recommends
The FDA’s review of the products is now underway and it is investigating the potential effects of the drug to the patients who have already taken them.
The FDA is also looking at ways to reduce or eliminate NDMA from future batches of valsartan.
For now, here’s what you need to do :
- Since the drug is used to treat serious medical conditions, the FDA recommends that patients who are already taking the recalled valsartan should continue doing so until a replacement product is found.
- To find a suitable replacement drug, patients with the recalled products should contact their doctor or pharmacist as soon as possible.
- Additionally, if a patient is taking one of the recalled products, they should follow the recall instructions provided by the specific company. Note: These instructions will be posted on the FDA’s website.
- To determine whether a product is recalled, check the prescription bottle label for the drug name and the company name. If the information is not available, contact your pharmacy.
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