Pharmaceutical

FDA researcher wants lung cancer warning added to class of blood pressure drugs

fda logo FDA researcher wants lung cancer warning added to class of blood pressure drugsThomas Marciniak, a scientist for the Food and Drug Administration (FDA), wants the agency to warn consumers that a class of high blood pressure drugs may cause lung cancer.

Marciniak’s concern arises from a 2010 study that concluded that angiotensin receptor blockers, or ARBs, taken by millions of people to treat high blood pressure, could increase the risk for cancer, in particular lung cancer. The study found people who used ARBs, which include the brand-name drugs Diovan and Cozaar, had a 25 percent greater risk of developing lung cancer.

The study prompted the FDA to conduct its own safety review, but a year later the agency dismissed any risk of cancer associated with the drugs.

Marciniak, however, wasn’t satisfied with the FDA’s response, arguing that agency researchers used data provided by drug companies. He worked on his own, seeking out patient data, and found a similar risk as previous studies – that people taking ARBs had a 24 percent risk of developing lung cancer.

Now Marciniak is urging senior FDA officials to take action and warn consumers of the risks associated with ARBs. “The FDA must act now,” the Wall Street Journal quoted him as saying.

The FDA contends that the cancer risk Marciniak and previous studies identified with ARBs is not relevant, and that it is possible that the patient data Marciniak used may have over-counted cancer cases.

ARBs generated more than $7 billion in sales in 2012, and continue to be a leader in the treatment of high blood pressure.

Source: FiercePharma