Pfizer ME welcomes US ruling on marketing of pain killers
April 12, 2005
The US Food and Drug Administration (FDA) has announced a series of important changes to the marketing of prescription and over-the-counter pain killers, in a move aimed at maximizing their benefits and reducing their risks to consumers in the United States, but it is expected that other country’s, including those in the Middle East, will look to the decision as strong counsel as to how they should rule on the use of such drugs in their own markets.
The US regulatory agency has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label, and the company has agreed to work with the FDA on the boxed warning for the drug. Pfizer has also agreed to suspend all sales and marketing of one of its other pain killers, Bextra (valdecoxib), in the United Arab Emirates because of risks of potential rare but serious skin reactions.
In the Middle East, drug executives welcomed the news that Celebrex has been determined by the FDA to present a positive overall risk/benefit profile and are predicting an upsurge in sales of the drug, as patients can now rest assured that the pain killer they are taking has been proven to be absolutely safe.
“The FDA ruling that Pfizer’s prescription pain killer, Celebrex, is no more dangerous than that of over-the-counter pain relievers, such as Ibuprofen, is a global endorsement of the drug’s safety and efficacy,” said Dr. Ahmed El-Hakim, Director of External Affairs and Policy at Pfizer Middle East.
“In the Middle East, we will continue to work with doctors, patients, and regulatory authorities to ensure that Pfizer drugs are in compliance with all country-specific rules, including those which relate to the marketing of our medicines,” concluded Dr. El-Hakim.