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FDA adds new safety warnings to statins.

Coverage of the FDA's decision to add warnings to the labels of statins was widespread and presented the warnings as acknowledging a serious danger, while repeating that statins are still useful and effective medications. FDA has recently announced that it will slap new safety warnings on the packages" of statins, "including a warning about confusion and memory loss." "The warnings will include the side of memory loss, confusion, a rise in blood sugar, which can lead to diabetes, and drug interaction causing muscle damage."

It has been further reported that the "FDA has issued new warnings that" statins "are not, of course, without their risks." "There's no doubt that statins save lives...and experts emphasize people should not stop taking them without talking to their doctor, but the experts say these latest warnings might make some doctors think twice about prescribing the drug for people not at high risk." According to FDA the benefits for most patients outweigh the risks."

This is the first time that the" agency "has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years." The medications include "Lipitor [atorvastatin], Zocor [simvastatin], Crestor [rosuvastatin] and Vytorin [simvastatin/ezetimibe]."

According to yet another report "The drug known as lovastatin (which is known by several brand names, including Mevacor [lovastatin]) can cause muscle weakness in rare cases." However, "the new warnings are not likely to cause doctors to pull their patients off the medications."

"A growing number of studies published over the last five years have found a link between statin use and type 2diabetes," the AP (2/29) explains. "In addition to the label additions, the FDA said it will remove a long-standing warning related to liver injury." In a study published last June "in the Journal of the American Medical Association," it "analyzed five older randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin."

"Statin-takers no longer need to undergo routine monitoring of their liver enzymes, since the FDA has 'concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.'" But "liver enzyme tests should still be performed before starting statin therapy and in those who have symptoms of liver problems."

"The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products."

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Publication:Pulse International
Geographic Code:1USA
Date:Jul 14, 2012
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