Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen
Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen
Valsartan is a generic drug mainly used for treatment of high blood pressure and congestive heart failureMore
20 July, 2018, 21:44
NDMA is a potential human carcinogen, which means long-term exposure to it could cause cancer, according to the International Agency for Research on Cancer.
Patients who take Valsartan should contact their doctor or pharmacist for an alternative treatment.
Ministry of Health also has directed all to to stop using anything that contains the concerned chemical from the mentioned company. They are also used by patients who have had heart failure or a recent heart attack.
The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied valsartan on July 5, said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.
Scott Gottlieb said "The FDA is committed to maintaining our gold standard for safety and efficacy".
TEVA is notifying its Direct Accounts by FedEx Overnight mailing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts of this product recall and making arrangements for impacted product to be returned to Inmar.
In addition to Anginet and Co-Anginet produced by the Jordanian United Pharmaceuticals Manufacturing Co and Valzaar manufactured by the Indian Torrent Pharmaceuticals.
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The FDA recommends that patients continue taking the medication until they can get a replacement, because it is used to treat "serious medical conditions".
The companies can manufacture and sale valsartan medicine made from valsartan raw material imported from other qualified sources, the statement said.
The Chinese manufacturer of a widely used blood pressuremedication said it had launched a global recall after U.S. and European regulators warned of contamination by a cancer-causing impurity.
Zhejiang Huahai Pharmaceutical produces the active substance Valsartan.
Teva Pharmaceuticals USA has announced a voluntary recall of 80 lots containing its hypertension therapy valsartan (Diovan).
The FDA has said it will "continue to investigate this issue and provide additional information when it becomes available".
The recall in the United States includes versions of valsartan made by Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries.
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