JEDDAH, 4 March 2005 — Two weeks after the US Food and Drug Administration (FDA) Advisory Committee unanimously approved the continued use of all COX-2 class pain medicines in the US market, the Saudi Ministry of Health is yet to make a decision on allowing the medications in the Saudi market.
On Feb. 18, members of the FDA advisory panel voted to recommend keeping Bextra and Celebrex on the market. The Celebrex vote was an overwhelming 30-1. But the vote on Bextra was much closer, 17-13, and the vote was even narrower, 17-15, for Vioxx, the drug that had been under the darkest cloud. Vioxx was voluntarily withdrawn from the market last September by its manufacturer Merck after company trials showed increased heart problems. A majority of the panel members also recommended against direct-to-consumer advertising for the drugs. They also recommended strong individually tailored ‘black-box’ warnings for the cardiovascular risk. The committee also suggested that the FDA be given more authority, including changing how drug-makers communicate risk to patients. FDA officials said that they welcomed the committee’s recommendations on advertising and might ask drug-makers voluntarily to stop marketing the drugs in this way. In December, Pfizer stopped advertising Celebrex after a trial showed heart risks.
“The report by the advisory panel is good news because FDA guidance is not only important in the US but to all health authorities around the world,” said Dr. Ahmed Al-Hakim, Pfizer’s Cairo-based regional director of external affairs and policy. He told Arab News that health authorities in the region has stopped the import of Bextra as a precautionary measure, although both Bextra and Celebrex were allowed to be sold with a prescription, and now Pfizer is waiting for the region’s health authorities to allow marketing it. “The report said that Celebrex is safe and effective, provided that Pfizer places a small warning in the packaging for people with established history of heart disease and cardiovascular risk,” said El-Hakim to Arab News. He explained that even though Vioxx, Celebrex and Bextra belong to the same class of drugs, they are completely different medicines with different side effects. He expects the FDA would approve the selling of these medications in the next few days.
“We have to wait for an official document from the FDA about their findings and decision,” said Dr. Khalid Merghalani, spokesperson and general director of health awareness at the Ministry of Health. “The Ministry also does its own evaluation to determine the safety of the drugs and put regulations on its use and availability,” he said.
A day before the FDA Advisory Committee report came out, the European Medicines Evaluation Agency (EMEA) — which coordinates the evaluation and supervision of medicinal products in Europe — also had high praise for Pfizer’s pain drugs. The EMEA ruling of Feb.17 reaffirmed that COX-2 pain medicines are an important treatment option for arthritis patients. However, Germany will issue guidelines in the next few days to significantly restrict the use of so-called COX-2 inhibitors to ease pain, the country’s drug regulator said on Monday. Patients who either have had a heart attack or stroke, suffer from circulatory disorders of the heart or are at a high risk of developing such conditions should no longer use the medications, the regulator said in a statement.
Selective COX-2 medicines were designed to relieve pain with fewer gastrointestinal side effects associated with older generation pain medicines, known as non-specific, non-steroidal, anti-inflammatory drugs (NSAIDs). Celebrex, for example, which has been studied in tens of thousands of patients worldwide, has been shown to be not only effective in reducing pain and inflammation, but does so with less incidence of the serious gastrointestinal side effects associated with the older generation NSAIDs. While this NSAIDs is well-documented, there is little information on the long-term cardiovascular risks associated with these agents.
