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Statin labels will get new safety warnings
Mar 01, 12 FDA warningsIn a statement, Pfizer, maker of Lipitor, one of the top-selling prescription drugs in the world told CNN: “The announcement today by the FDA provides additional information to physicians and patients regarding Statins including Lipitor (atorvastatin calcium). The class labeling is based on FDA evaluation of all statin labels, entry of new interacting drugs on the market, and a review of clinical data and post marketing reports. Lipitor has been supported by a wealth of clinical research and real-world experience and has been studied in more than 400 ongoing or completed trials, including more than 80,000 patients and is backed by more than 19 years of clinical experience and more than 200 million patient-years of experience.”
Amy Egan, deputy director for safety in the FDA’s Division of Metabolism and Endocrinology Products, says the agency looked at the adverse events reported to determine the scope of the problem. They can’t say what caused the memory loss and confusion, but it seems to be a class effect and a rare event.
The statin labels will also now reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs, the agency said. It said those reports generally have not been serious and the symptoms were reversed by stopping use of the statin.
One safety warning long associated with the class of medicines will be reversed, the FDA said: Patients taking Statins will no longer need routine periodic monitoring of liver enzymes.
“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 this rare side effect,” it said.
Other Statins, most of which are available as generics, include Livalo, Mevacor, Pravachol, Altoprev and Lescol. There are also combination medicines that include Statins, such as Merck’s Vytorin and Abbott Laboratories’ Simcor.
The agency also said Merck’s Mevacor, the world’s first approved statin, known generically as lovastatin, should never be taken with certain drugs used to treat HIV and certain bacterial and fungal infections due to increased risk of a serious muscle disease.
“When we looked at these reports they ran the gamut - memory loss, memory impairment, confusion - and they were occurring anywhere from one day after initiation of the statin to years after initiation.” Egan said. “We could not identify if it was age specific because it was across a range of age groups. We did not see it occurring as a drug interaction, where patients were also taking other medications that were reacting with the statin to cause the confusional state. But we really want to get the message out there that we do not consider this a major problem, and certainly it does not outweigh the tremendous benefits of statin therapy.”
James Howard, director of the Lipid Clinic at MedStar Washington Hospital Center in Washington, DC, says the new changes are a real step forward. He says the concern over an increased risk of diabetes is valid but not a reason to shun Statins.
“The diabetic has a significant increased risk for heart disease, and the most clearly demonstrated therapy that will affect that is to control their cholesterol and their blood pressure,” Howard said. “Statins are very important in diabetics to reduce their risk of heart attack and stroke. So the benefit they will receive in that reduction in risk far outweighs the risk of developing diabetes. It’s a small risk, but it’s a lot of people.”
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CNN NewSource.
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