Rezulin generated $2.1B in sales — the FDA officer who said no was removed, 63+ died

Rezulin (troglitazone) was a diabetes drug that promised a new way to treat type 2 diabetes by reducing insulin resistance. Approved by the FDA on 29 January 1997, it became a blockbuster — generating over $2.1 billion in sales for Warner-Lambert within three years. But the approval process was deeply compromised. The FDA's own medical officer, Dr. John Gueriguian, had recommended against approval because of liver toxicity signals in the trial data. After Warner-Lambert complained about him, he was removed from the review.

The first death occurred in an NIH study in May 1998 — patient Audrey LaRue Jones died of acute liver failure despite being closely monitored. The FDA's own epidemiologist, David Graham, later warned that Rezulin caused liver failure at 1,200 times the background rate and estimated that over 430 liver failures were linked to the drug. Despite this, the FDA did not withdraw Rezulin until March 2000 — nearly two years after the first confirmed death.

By the time Rezulin was pulled, it had been linked to at least 63 deaths from liver failure in the US alone, with many more injuries. The UK had already withdrawn it in December 1997. In 2000, Pfizer acquired Warner-Lambert and inherited the liability. In 2009, Pfizer paid approximately $750 million to settle about 35,000 claims. The company had set aside $955 million for Rezulin cases in 2004. The case is taught as a failure of both drug development and regulatory oversight.