FDA flags diabetes risks with statin drugs

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Big-selling cholesterol drugs got new warnings on their labels, but the cautionary language about blood sugar and memory loss isn't expected to diminish their popularity much. In a safety communiqué, FDA outlined the new cautionary language, but also pointed out that "these medications continue to provide an important health benefit." Experts agreed, saying that most patients should stay on the drugs, but keep an eye out for side effects.

The FDA said statin products--such as Pfizer's ($PFE) Lipitor, AstraZeneca's ($AZN) Crestor, and Merck's ($MRK) combo drug Vytorin--will get new labels that flag a potentially increased risk of developing Type 2 diabetes and report cognitive problems experienced by some patients. The drugs are taken by millions of patients, and have been among Big Pharma's biggest earners, with billions of dollars in sales. With several key drugs now off patent, however, they're contributing less to drugmakers' bottom lines.

Agency officials said the cognitive effects could be "quite dramatic" but that they wane once patients stop the drugs. It's the diabetes risks that appear to worry cardiologists most: As The Wall Street Journal reports, some doctors believe that, over the long term, the increase in diabetes cases all but outweighs the cardiovascular benefits. Eric Topol of the Scripps Institute told the Journal that 1 in 200 statin users develop diabetes, while 1 to 2 of 100 users at risk of heart attack will avoid one. "That's a very narrow margin of benefit," he pointed out.

But Steven Nissen, Cleveland Clinic's chief of cardiovascular medicine, told the WSJ that, in his mind, the diabetes risk "has no impact on the risk-benefit assessment" for statin use. "The bigger picture doesn't change," Nissen told Reuters. "There are few drugs that have saved as many lives as statins." But he acknowledged that statins aren't for everyone. "We don't think these drugs should be put in the water supply," he said.

- see the release from FDA
- get the Reuters news
- read the WSJ article

ALSO: People with heart disease who use statin drugs may have a lower risk of depression, a U.S. study found. Report

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