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FDA Expert Examines Cholesterol Drug Safety

Nov. 22, 2004 — Despite concerns around popular cholesterol-lowering “statin” drugs, a modern think about shows that most of these drugs have a moo hazard of a genuine muscle disorder.

The think about was released early in reaction to controversial articulations from an FDA scientist final week. That researcher, David J. Graham, MD, MPH, is also the lead analyst of the unused ponder.

Last Thursday, Graham spoke to Congress approximately drug safety and the issues with the joint pain medicate Vioxx, which was expelled from the racks in October due to concerns it increases the chance of heart attacks and strokes. At that hearing, he too involved five other drugs, as having safety concerns.

One of those drugs was the cholesterol-lowering sedate Crestor, a member of the lesson of drugs called statins. Graham tells WebMD that the new consider was started some time recently Crestor became available in Admirable 2003 and therefore, he did not look at that statin drug.

Graham’s ponder looked at the risk of a potentially serious muscle clutter called rhabdomyolysis among patients taking a statin medicate — either Baycol, Lipitor, Pravachol, or Zocor. Baycol was removed from the advertise in 2001 in the wake of reports that it had led to rhabdomyolysis and passing in 31 individuals.

Rhabdomyolysis happens when muscle tissue breaks down, discharging tall levels of chemicals in the circulatory system that can cause kidney disappointment.

Statin Drug Chance “Comparative and Moo”

Graham’s ponder included information based on more than 252,000 individuals treated with a statin sedate or another cholesterol-lowering medicate.

Graham found that nearly one out of each 23,000 individuals taking a statin drug alone developed rhabdomyolysis. The chance hopped ten times in individuals taking Baycol, supporting the theory that this statin medicate carried a much larger risk.

The analysts found that when a statin drug was combined with other cholesterol-lowering drugs called fibrates, such as Lopid and Tricor, almost 60 of every 100,000 individuals created rhabdomyolysis.

Graham says the hazard of the muscle problem was “comparable and low” for the statin drugs Lipitor, Pravachol, and Zocor. The study will show up in the Dec. 1 issue of The Journal of the American Restorative Affiliation.

In any case, Graham says the hazard may be significantly higher in more seasoned patients with diabetes, where roughly one in 500 patients per year could develop muscle injury.

What Almost Crestor?

In June, the FDA exhorted doctors to be careful about how they endorse Crestor.

The counseling followed label changes in Europe reflecting cautions for patients older than 65, those with underactive thyroids, and individuals with kidney problems, particularly at the drug’s most noteworthy measurements, 40 milligrams. Those dangers were as of now included on U.S. labels, according to news reports at the time.

Crestor’s producer, AstraZeneca, released a statement in reaction to Graham’s congressional hearing comments saying it is “fully confident within the security profile of Crestor, which has presently been approved in more than 65 countries around the world.

“To date, the FDA has not given the company any indication of a major concern regarding Crestor, and the comments nowadays are inconsistent with past public statements from the FDA and our understanding of its current see of the safety and viability of Crestor.”

What Ought to Patients Do?

If patients develop muscle soreness, they should halt their medicine and call their specialist to be checked out for muscle injury, Graham tells WebMD. He says the commonplace persistent in his study developed muscle soreness and pain approximately five to six days some time recently being hospitalized with muscle injury.

Dark pee is another sign of possible muscle damage that should alarm patients to call their specialist.

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