FDA Says Up To Two Million People Exposed To Likely Carcinogens In Blood-Pressure Drugs (#GotBitcoin?)

Half or more of patients taking common hypertension medicines are in U.S., agency says. FDA Says Up To Two Million People Exposed To Likely Carcinogens In Blood-Pressure Drugs

As many as two million people world-wide have been exposed to a class of generic blood-pressure drugs containing probable human carcinogens from raw-material facilities in China and India, according to U.S. officials.

Half or more of the patients taking the common hypertension medicines are in the U.S., the Food and Drug Administration officials said. The drugs are certain lots of some manufacturers’ products, including generic drugs going by the names valsartan, irbesartan and losartan.

Not all generic products are affected, nor are the brand-name versions of the medicines, called Diovan, Avapro and Cozaar. The FDA’s website contains details about which lots and companies are affected. The number of generic-drug versions that contain the class of chemicals, called nitrosamines, has been increasing since the issue first surfaced last summer.

Companies whose lots of the drugs have been recalled include Solco Healthcare LLC, Torrent Pharmaceuticals Ltd. , Aurobindo Pharma USA and Teva Pharmaceutical Industries Ltd.

The FDA assessed the risk to individual patients as being small. For example, FDA scientists have estimated there “may be one additional case of cancer” among 8,000 people if those people took the highest daily dose of valsartan constantly for four years. Because many people take different generic drugs and differing dosages, and because not all lots are affected, the risk is less, the agency said, than “this worst-case scenario.”

The FDA has said the impurities in question, which go by the chemical names NDEA and NDMA, resulted inadvertently from the manufacturing process of a drug raw-material supplier in Linhai, China, called Zhejiang Huahai Pharmaceutical Co. The FDA has placed a Zhejiang Huahai facility on import alert to stop all of its material and finished drugs from entering the U.S. legally.

Zhejiang Huahai didn’t immediately respond to a request for comment.

Impurities have subsequently been found in blood-pressure drugs originating in India.

The FDA said its inspections revealed “systemic problems of supervision that could have created the conditions for quality issues to arise.” It said that a change in manufacturing process probably led to the presence of the impurity.

“The impurity went undetected by global regulators, including the FDA, for a period of time,” the agency said. “Before we undertook this analysis, neither regulators nor industry fully understood how NDMA or NDEA could form during this particular manufacturing process.”

The agency said the chemical impurities occur in trace amounts in water and some foods.

Patients take this class of drugs, known as angiotensin II receptor blockers, or ARBS, for blood pressure and heart failure.

Several companies that continue to sell valsartan have raised their prices substantially during the period since the FDA recalled products made by some other makers.

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Monty H. & Carolyn A.