I am both shocked and appalled at the recent decision by the FDA advisory panel to re-approve Vioxx and put the stamp of safety on all Cox-2 inhibitors, including Bextra and Celebrex.
A five-year study by researchers at the Royal Children's Hospital in Melbourne found Nurofen and Celebrex caused children to vomit blood, suffer acute kidney failure and develop rashes.
Researchers at the Royal Children's Hospital in Melbourne studied adverse drug reactions over a five-year period after concern was raised about significant reactions to non steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors.
The FDA asked all manufacturers of NSAIDs to revise the labeling for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular events and the well described, serious, potential life-threatening gastrointestinal bleeding associated with their use.
Pharmaceutical companies have altered medical research statistics and concealed negative trial results to make their products seem more effective or safer.
One of the most popular in the COX-2 class, Vioxx - used by tens of millions of people worldwide - was pulled off the market last October. This decision came shortly after medical conference where FDA researcher David Graham showed higher doses of Vioxx correlated with a tripled risk of heart attack or sudden cardiac death compared to people who weren't taking any similar drug.
The U.S. government announced it has halted the use of Celebrex in a cancer trial because of heart risks, and it is reviewing the safety of all its clinical trials using similar painkillers.
Shares of Pfizer fell after the drug giants disclosure that New York Attorney General Eliot Spitzer has asked for information relating to its clinical trials and marketing of certain unnamed drugs.



