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FDA controversy brews over safety of blood pressure medications

Sometimes it takes a certain kind of pressure to inspire change. Rather than preventing harm from the start, sometimes concerned individuals are forced to respond to harm already occurring before public safety can be better ensured. Recently, a senior regulator employed at the Food and Drug Administration (FDA) was inspired by the pressures associated with potential drug side effects affecting millions of Americans to seek more stringent warnings on a top-selling class of prescription blood-pressure medications.

The regulator is concerned that angiotensin receptor blockers (ARBs) may be linked to an increased risk of developing cancer. The FDA has yet to confirm this link, though many outside physicians have expressed concerns consistent with those being voiced by the rogue regulator.

Given that millions of Americans are prescribed drugs in this class every year, the implications of this potential link are particularly staggering. However, it is a uniquely challenging feat to prove or dispel a long-term link between certain drugs and cancer, especially when the drugs are relatively new and a significant sample size of patients has yet to live long enough to confirm or deny such linkage.

Though it is unclear what will be done about concerns related specifically to ARBs and a potential cancer link, this controversy is causing many to question whether the FDA places enough emphasis on the long-term effects of drugs during the testing, approval and post-approval investigation stages of its work. If keeping the public safe from dangerous and defective drugs is a primary objective of the FDA, long-term consequences of the drugs it approves should certainly be a significant focus.

Source: Fox News, "Dispute flares within FDA over safety of popular blood pressure drugs," May 31, 2013

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