The sale of painkiller Bextra, which has been suspended in Europe and the United States due to concerns that it causes serious skin reactions, has been suspended in Malaysia.
The drug, which is used to treat acute pain, primary dysmenorrhoea, rheumatoid arthritis and osteoarthritis, was launched here in April last year.
The United States Food and Drug Administration (FDA) had on Thursday asked Pfizer Inc, the manufacturer of the drug, to voluntarily remove Bextra from the market following reports of serious and potentially life-threatening skin reactions, including deaths, in patients.
The risk of these reactions in individual patients is unpredictable
“The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa (a chemical substance in antibiotics) allergy and after both short- and long-term use,” the FDA said on its website.
Another reason for the removal of the drug was the lack of adequate data on the cardiovascular safety of long-term users of the drug.
Pfizer Malaysia said yesterday that it had voluntarily suspended the sale of Bextra with immediate effect, in line with the FDAâ€™s recommendations, and after consulting with the Health Ministry.
“FDA had informed Pfizer that Bextra’s cardiovascular risk could not be differentiated from other non-steroidal anti-inflammatory drugs (NSAIDs).
“In deference to the FDA’s views, Pfizer Inc has agreed to suspend sales of Bextra pending further discussions with it.
“Patients using Bextra are advised to contact their doctors regarding discontinuing its use and seeking alternative treatment,” the company said in a statement issued yesterday.
The FDA had also asked manufacturers of all marketed prescriptions of NSAIDs, including Celebrex, to include a boxed warning highlighting the potential risks of cardiovascular and gastrointestinal bleeding associated with its use.
Last September, the anti-inflammatory drug Vioxx was voluntary withdrawn from the Malaysian market by its manufacturer Merck after it was found to have doubled the risk of heart disease and stroke.