FDA restricts anti-cholestrol drug heavy dosage

NEW DELHI: The American drug regulator has put restrictions on use of high dose of anti-cholesterol drug simvastatin which would have insignificant impact on revenues of Indian firms who sell generic versions of this drug in the world’s largest drug market.

"The agency has recommend use of simvastatin 80 mg only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity and not prescribed to new patients," US Food and Drug Administration ( FDA) said in a statement on Wednesday. There are also new contraindications and dose limitations when simvastatin is taken with certain other medications, it said.

Simvastatin is sold under the brand-name Zocor by American firm Merck & Co and is used to reduce the amount of bad cholesterol in blood. Several Indian firms such as Ranbaxy, Dr Reddy’s and Zydus Cadila sell their generic drugs as Zocor is off patent. Sales from the generic simvastatin for these firm is very small since it is off patent and there are many generic equivalents in the market, industry experts said.

The changes are based on the FDA’s review of the seven-year about effectiveness of additional reductions in cholesterol and homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s adverse event reporting system, it said. It has also made similar reservation for combination drugs using simvastatin.