Federal health officials Tuesday added new safety alerts to the prescribing information of statins, cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.
It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are such huge sellers as Lipitor, Zocor, Crestor and Vytorin.
But federal officials and some medical experts said the new alerts should not scare people away from statins.
"The value of statins in preventing heart disease has been clearly established," said Dr. Amy Egan, deputy director for safety in the FDA’s division of metabolism and endocrinology products. "Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects."
Diabetics and even those who develop diabetes while taking statins should continue taking the medicines, said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. Nissen has studied the medicines extensively.
"These are not major issues, and they really do not alter the decision-making process with regard to statins," Nissen said.
The FDA said that routine monitoring of liver enzymes in the blood, once considered standard procedure for statin
users, is no longer needed because the liver injury associated with statin therapy is so rare.
Reports about memory loss, forgetfulness and confusion span all statin drugs and all age groups of patients, the FDA said. There have been dozens of well-controlled trials of statins, but they have offered few hints that the drugs cause any kind of cognitive impairment, Egan said. Still, the FDA has received many reports that some patients felt unfocused or "fuzzy" in their thinking after taking the medicines.
Officials within the FDA debated whether such reports were truly worrisome, Egan said. But in recent years, the FDA — criticized for waiting too long to issue some safety alerts — has become much more willing to be public about its uncertainty.
"We are trying to be as transparent as possible with our alerts and labeling," Egan said, even though the alert on the possibility of fuzzy thinking "is not overly helpful."
Statins seem to increase blood sugar levels in some patients by small amounts, and when millions are treated, that change leads more to be diagnosed with diabetes. The FDA had already placed an alert about diabetes risks on the label of Crestor, a big-selling statin made by AstraZeneca, because a Crestor trial showed an increased risk. The agency decided to extend that alert to all drugs in the class with the exception of Pravachol, an older medicine manufactured by Bristol-Myers Squibb. A well-controlled trial of Pravachol had previously shown that it reduced the risks of developing diabetes by 30 percent, but other trials have found that Pravachol is not as effective in reducing cardiac risks.
Egan suggested that doctors check the blood sugar levels of patients after starting them on statin therapy…
Statistics: Posted by yoda — Fri Mar 16, 2012 12:26 am
View full post on opinions.caduceusx.com