FDA recall of Bextra
Bextra is the brand name for valdecoxib. It is an oral drug for treatment of pain. It is one of the NSAIDs. NSAIDs are nonsteroidal anti-inflammatory drugs. It is used for treating pain, swelling, fever and tenderness, which is caused by arthritis. It acts by affecting production of prostaglandins. Prostaglandins are chemicals, which produce pain and swelling of joints in arthritis. It blocks one of enzyme responsible for production of prostaglandins. Thus pain and swelling of joints is reduced. It is also prescribed for menstrual cramps. It is manufactured by Pfizer Inc.
The U.S. Food and Drug Administration (FDA) approved Bextra on November 16, 2001 for relief of the signs and symptoms of both types of arthritis. The marketing of the drug started in March 2002. FDA also issued warnings and product label changes for Bextra in November 2002.
FDA got several reports of serious reactions of this drug including skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. It also showed hypersensitivity reactions. The warning and label change of Bextra by FDA was fully accepted by Pfizer. It sent letters to physicians to intimate them the warning and label changes on November 13, 2002.
The FDA action included
- Strengthening of the warning on label regarding the possibility of serious skin reactions by use of Bextra. These reactions also included Steven-Johnson Syndrome and toxic epidermal necrolysis, which could even result in death.
- The label also got a new warning about possible heart and blood clotting problems. It warned patients who have just had coronary artery bypass graft surgery are more prone to these problems.
This change of label was a result of a study showing ill effects of Bextra. This study involved around 1500 patients who had gone through cardiac surgery. The study revealed patients using Bextra were more prone to heart and blood clotting problems than other patients. These side effects included heart attack, stroke, deep vein thrombosis and pulmonary embolism. FDA made sure that patients got all the information available about the drug and their side effects.
The US Food and Drug Administration (FDA) held a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Arthritis Advisory Committee from February 16 to 18, 2005 to evaluate the benefits and health risks of non-steroidal anti-inflammatory drugs (NSAIDs).
This committee had 32 panelists: 8 rheumatologists, 19 physicians, 8 epidemiologists and biostatisticians, 1 ethicist and several patient and 2 industry representatives. It was finally found out that Bextra increases the risk of heart attacks. It was concluded that risk associated with this drug is more than its benefits. Then FDA requested recall of Bextra in 2005. Pfizer Inc. suspended sales of Bextra in the United States and the European Union voluntarily. The company said that the FDA has requested withdrawal on basis of risk of serious, sometimes fatal, skin reactions associated with Bextra along with other risks, which are associated with other similar drugs too.
Though a similar drug by Pfizer, Celebrex was allowed to be sold but it was asked to carry a black-box warning on its label to warn users of increased risk of cardiovascular side effects.