Thirty states on Monday reached an $8 million settlement agreement with Bayer regarding allegations that the drug company failed to adequately warn consumers about risks associated with its cholesterol-reducing drug Baycol^® (cerivastatin). The company must pay $8 million to the states for future consumer protection and enforcement programs.

Drugs to reduce cholesterol are of a class known as “statins”. All statins carry a known risk of myopathy, a weakening of the muscles, and rhabdomyolysis, a potentially fatal muscle reaction that is known to cause severe pain and kidney failure.

Papers filed in state courts show that the company learned after introducing Baycol in the U.S. in May 1998, that the drug posed considerably greater health risks than similar drugs, especially when taken in higher doses or in combination with another cholesterol-lowering drug, genfibrozil. Bayer withdrew Baycol from the market in August 2001. Lawyers suing Bayer released documents back in February 2003, showing that the company was aware of serious problems with cerivastatin long before the Food and Drug Administration (FDA) ordered the drug pulled from the market.

The suits state that Bayer informed the FDA about Baycol’s elevated risks but failed in its marketing to adequately disclose safety risks associated with the drug to physicians and consumers.

Attorney Generals participating in the settlement represent the following states: Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin. Pennsylvania, Vermont, Oregon, Michigan and Connecticut each will receive $600,000 as part of the settlement. The other states will receive $200,000 each.

In addition to the $8 million to the 30 states, the settlement requires Bayer to register most of its clinical studies and then post the results at the end of each study. The judgment also orders Bayer’s future compliance with the law in the marketing, sale, and promotion of its pharmaceutical and biological products, and prohibits Bayer from making false and misleading claims relating to any such product sold in the United States.

The company made the agreement “without admitting wrongdoing or conceding a violation of law or liability.”

“Bayer has entered into this agreement to settle our disagreement with these various states and to avoid unnecessary expense, inconvenience, and uncertainty,” Bayer’s chief legal officer, George Lykos, commented in the press statement. “We are gratified to achieve this agreement and have this matter behind us.”

SOURCE: http://www.prnewswire.com/ Baycol is a registered trademark of Bayer, AG.