History of family of painkillers marked by uncertainty
Key events involving the safety of Vioxx and other painkillers:
December 1998: Food and Drug Administration approves Pfizer Inc.'s Celebrex, the first Cox-2 inhibitor, to treat arthritis. Cox-2 drugs fight inflammation, but protect users against stomach bleeds and ulcers.
May 1999: FDA approves Merck & Co.'s Vioxx, another Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
June 2000: Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's heart-protection qualities rather than a defect in Vioxx, garnering a rebuke from the FDA for making that assertion without scientific proof.
September 2001: Merck gets a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign ''that minimizes the potentially serious cardiovascular findings."
November 2001: FDA approves Pfizer's Bextra, also a Cox-2 inhibitor.
April 2002: FDA changes warning label on Vioxx to reflect VIGOR study results.
September 2004: Merck stops long-term APPROVe study, saying it showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. Merck voluntarily withdraws Vioxx from the market.
February 2005: FDA panel concludes Vioxx, Celebrex, and Bextra all pose heart risks, but should be available to consumers.
April 7, 2005: Pfizer withdraws Bextra from the market at request of the FDA, which said it carries additional risks of serious, sometimes fatal skin reactions. The FDA also says not just Cox-2 inhibitors, but all prescription NSAID drugs, should carry a warning label about heart risks.
Aug. 19, 2005: Texas jury finds Merck liable for the 2001 death of Robert Ernst, awarding his widow $253.4 million in damages. That will be reduced to about $26 million under Texas caps on punitive damages; Merck plans to appeal.
Oct. 24, 2005: In its quarterly earnings report, Merck says that as of Sept. 30, it has been named as a defendant in about 6,400 lawsuits over Vioxx -- about 160 of them potential class actions -- and has signed agreements with about 3,000 other claimants temporarily suspending the clock on their states' time limits to file suit. At least several hundred additional lawsuits are filed in October.
Nov. 3, 2005: Atlantic County Superior Court jury rules Merck & Co. not responsible for heart attack of Boise, Idaho, postal worker Frederick ''Mike" Humeston.
Dec. 12, 2005: A judge in Houston declares a mistrial in the first federal lawsuit over Vioxx. The trial ends with a hung jury after the panel failed to side with the drug maker or the widow of 53-year-old Richard ''Dicky" Irvin, a Florida man who died after taking Vioxx for about a month.
Feb. 18, 2006: A federal jury in New Orleans takes up the Irvin case in a retrial and finds Merck wasn't responsible in Irvin's death.
April 5, 2006: A jury in Atlantic City, N.J., finds Merck liable for New Jersey resident John McDarby's nonfatal heart attack, but not for one suffered by fellow plaintiff Thomas Cona.
SOURCE: Associated Press
