Post by scumbuster on Jul 16, 2018 4:14:41 GMT -5
FDA recalls heart meds used to treat high blood pressure over cancer concerns
The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”
Officials say NDMA is classified as a probable human carcinogen —a substance that could cause cancer. They said those findings are based on results from recent laboratory tests.
The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”
To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
Below are the specific medicines being recalled:
Medicine Company
Valsartan
Major Pharmaceuticals
Valsartan
Solco Healthcare
Valsartan
Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)
Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)
Teva Pharmaceuticals Industries Ltd.
“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. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Patients already taking the recalled medications should contact their pharmacist or doctor immediately, the FDA says.
www.charlotteobserver.com/news/nation-world/national/article214917390.html
The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”
Officials say NDMA is classified as a probable human carcinogen —a substance that could cause cancer. They said those findings are based on results from recent laboratory tests.
The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”
To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
Below are the specific medicines being recalled:
Medicine Company
Valsartan
Major Pharmaceuticals
Valsartan
Solco Healthcare
Valsartan
Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)
Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)
Teva Pharmaceuticals Industries Ltd.
“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. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Patients already taking the recalled medications should contact their pharmacist or doctor immediately, the FDA says.
www.charlotteobserver.com/news/nation-world/national/article214917390.html