Baycol killed 52 people — Bayer withdrew it and paid $1B in settlements

Cerivastatin, sold as Baycol in the US and Lipobay elsewhere, was a synthetic statin launched by Bayer in 1997 to lower cholesterol. It was approved in 80 countries and generated annual sales of approximately €700 million at its peak. But cerivastatin carried a risk of rhabdomyolysis — muscle breakdown that releases toxins into the bloodstream, causing kidney failure — that was 16 to 80 times higher than any other statin on the market.

By August 2001, 52 deaths had been linked to the drug worldwide (31 in the US, 21 elsewhere), along with 385 non-fatal cases of rhabdomyolysis. The risk was especially high at the 0.8 mg dose and when combined with gemfibrozil, another cholesterol drug. Bayer voluntarily withdrew Baycol from the global market on 8 August 2001. The FDA had already received reports of the drug's danger and was preparing to act.

Bayer faced over 3,000 lawsuits in the US. In 2005, the company agreed to a $1.07 billion settlement covering most of the claims. The withdrawal was a major blow to Bayer's pharmaceutical division, which had no other blockbuster drug to replace Baycol's revenue. The case became a textbook example of a drug that was approved with a known safety risk that the company failed to communicate adequately to doctors and patients.