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Valsartan 14 articles

Recalls cause shortage of high blood pressure drugs

Sweeping recalls of a class of high blood pressure drugs known as ARBs, or angiotensin II receptor blockers, has resulted in a shortage, Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and FDA director of drug evaluation and research Dr. Janet Woodcock said in a joint statement. And the problem will probably get worse. The shortage is among ARBs that contain the active drug ingredient valsartan, and may soon also affect other ARBs that contain losartan and irbesartan. The shortage is due to recalls of the drug over an unexpected impurity, which was identified as a chemical called NDMA ... Read More

As drug companies recall heart drug valsartan, other companies hike prices

Beginning in July, Teva Pharmaceuticals and Prinston Pharmaceuticals rolled out a series of recalls on the high blood pressure and heart failure medicine valsartan after a probable carcinogen was found in the drug. Another company, unaffected by the issue, saw a rare opportunity. Alembic Pharmaceuticals rushed to hike the prices of its similar drugs anywhere from 329 percent to 469 percent. And when the same potentially cancer-causing impurity was found in another high blood pressure medication, irbesartan, Alembic hiked the price of its irbesartan, too. The tactic proved an overwhelming success for the company, which reported “massive growth” in U.S. ... Read More

More heart drugs recalled due to presence of cancer-causing impurity

Two lots of Torrent Pharmaceuticals Limited’s Losartan potassium tablets are the latest heart drugs to be recalled due to the presence of a probable human carcinogen called N-nitrosodiethylamine (NDEA). Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in type 2 diabetic patients. Patients currently taking Losartan should continue taking the medication because the risk of harm may be greater if the treatment is stopped abruptly without an alternative medication. Patients should contact their pharmacist or physician with concerns. Torrent’s recalled Losartan potassium tablets include Losartan Potassium Tab, USP, 100mg, 30-count ... Read More

FDA updates consumers on tainted heart drugs investigation

The Food and Drug Administration (FDA) issued a warning letter to the China-based manufacturer of the active pharmaceutical ingredient (API) in the heart medication valsartan that is under investigation by the agency after the presence of a probable cancer-causing impurity was found in the drugs. The FDA’s warning letter outlines several manufacturing violations at Zhejiang Huahai Pharmaceutical Co. Ltd (ZHP), in Linhai, Taizhou Zhejiang China, including impurity control, change control and cross contamination from one manufacturing process line to another. The FDA is still looking for the root cause of the impurity, which the agency said previously may have been ... Read More

Mylan expands blood pressure drug recall

Mylan Pharmaceuticals is expanding its recall of high blood pressure and heart failure treatments to include all its products that contain the active ingredient valsartan because they may contain trace amounts of a potentially cancer-causing impurity. The 104 additional lots involved in the recall include varying doses of 26 lots of amlodipine and valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets. The tablets were distributed nationwide from March 2017 to November 2018. A list of affected drugs can be found on Mylan’s recall notice. The impurity found in the drugs is N-nitrosodiethylamine (NDEA), ... Read More

Class action lawsuit filed over tainted blood pressure meds

A second class action lawsuit was filed against manufacturers and distributors of a high blood pressure drug that was found to be contaminated with a probable cancer-causing impurity. The lawsuit was filed in Boston federal court against New Jersey-based Camber Pharmaceuticals Inc., and Hetero Drugs Ltd. Hetero is based in India but makes the drug ingredient, valsartan, with its partner, Hetero USA Inc., also based in New Jersey. The lawsuit claims poor safety procedures at the India plant should have tipped the companies off years ago that the drugs could be contaminated. Instead, the companies “willfully ignored warning signs.” In ... Read More

Third hypertension drug found to contain probable carcinogen

A third medication for high blood pressure has been found to contain trace amounts of a suspected cancer-causing agent, prompting another recall. This time, Sandoz Inc., recalled one lot of losartan potassium hydrochlorothiazide tablets after trace amounts of the impurity N-nitrosodiethylamine (NDEA) was detected. The active pharmaceutical ingredient losartan was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz’s losartan potassium hydrochlorothiazide is manufactured by Lek Pharmaceuticals dd, Ljubijana, Slovenia. NDEA is classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC). Losartan potassium hydrochlorothiazide tablets are used to treat hypertension. The drug ... Read More

Another heart drug recalled due to presence of cancer-causing agent

Another medication used to treat hypertension is being recalled after it was found to be contaminated with a suspected cancer-causing agent, the Food and Drug Administration (FDA) announced in a Safety Communication. Manufacturer ScieGen is recalling certain lots of the heart drug irbesartan. Affected products have printed on their labels the words “Westminster Pharmaceuticals” and “GSMS Inc.” The announcement comes on the heels of a recall of several lots of the high blood pressure and heart failure medication valsartan. Both irbesartan and valsartan are in a class of heart drugs called angiotensin II receptor blockers, or ARBs. And both were ... Read More

High levels of cancer-causing impurity found in heart drug valsartan

Levels of a carcinogenic impurity found in several brands of the high blood pressure and heart failure drugs containing the active ingredient valsartan are up to more than 2.5 times higher than what is considered “reasonably safe for human ingestion based on lifetime exposure,” according to a Food and Drug Administration (FDA) news release. The agency reported earlier that the impurity may have been present in some of the drugs for as long as four years. The impurity is called N-nitrosodimethylamine or NDMA. For reference, the FDA says that consuming up to 0.096 micrograms (mcg) of NDMA per day is ... Read More

Class action filed against makers, distributors of contaminated BP drug

A St. Louis man filed a class action lawsuit against a number of drug companies for manufacturing and distributing certain blood pressure and heart failure medications containing the active ingredient valsartan that may have been contaminated with a probable carcinogen. James Jones filed the lawsuit in the U.S. District Court for the Eastern District of Missouri two months after the Food and Drug Administration (FDA) informed the public about the issue and announced the first wave of recalls of drugs that contained valsartan. Companies named in the lawsuit are Zhejiang Huahai Pharmaceutical Co. Ltd., Prinston Pharmaceuticals, Solco Healthcare U.S. LLC, ... Read More