Pfizer: use Celebrex for childhood arthritis
Company wants to sell drug to children as young as two, despite link to heart risks - 11/27/06
About 1 in 1,000 children in the U.S. has juvenile rheumatoid arthritis. They have swollen, tender joints and can have enlarged livers and spleens as well as swollen lymph nodes as a result of the condition.
Pfizer Incorporated is now seeking permission to treat children who have arthritis with Celebrex, a drug subject to several personal injury lawsuits. The drug has been linked to an increase in heart risks in patients, and critics are calling for its removal from the drug market.
The Food and Drug Administration (FDA) was meeting on November 29, 2006 to consider the company's request for expanded use of the drug.
Results from several studies of Celebrex have shown it can triple the risk of a heart attack, stroke or heart failure. In addition, patients recovering from heart attacks who then took Celebrex had almost double the chance of dying and a significantly increased risk of having another attack.
"There are more studies confirming that these drugs double the risk of heart attacks," Dr. Curt Furberg, a professor at the Wake Forest University of Medicine, said. "If anything, use should be restricted."
Celebrex was the first Cox-2 inhibitor, a class of new-style painkillers, and was approved in 1998. It is now the last of its class of drugs to remain on the market. In 2005, pressure from the FDA caused Pfizer to remove Bextra, another cox-2 inhibitor, because of heart risks and possibly fatal skin reactions.
Vioxx, another cox-2 inhibitor from Merck & Company, was pulled from the market in 2004 after studies found it doubled the risk of heart attacks and strokes. The company now faces more than 20,000 Vioxx lawsuits.
In August 2004, the FDA approved Vioxx for children with rheumatoid arthritis. During the time it was available for pediatric use, the FDA received thousands of reports of serious side effects related to the drug use. Sixteen of the reports involved children younger than 16, six of which could be linked to Vioxx, including two cases of acute kidney failure. In addition, there were two reported deaths of 12- and 14-year-old girls who had heart complications.
Source: Diedtra Henderson, "Painkiller's use in children sought," Boston Globe, November 27, 2006.
Celebrex may cause heart attacks
On December 20, 2004, the U.S. Food and Drug Administration issued a warning to healthcare professionals and patients that Celebrex may be associated with an increased risk of adverse cardiovascular events, including …
