Jordan Times
Monday, February 21, 2005
JFDA welcomes US
panel decision on Celebrex
By Reem Halasa
AMMAN — Drug authorities in the Kingdom on Sunday welcomed a US Food and Drugs
Administration (USFDA) decision allowing Pfizer's pain killer Celebrex to remain
on the market, provided that it carries a warning for consumers.
The special panel of USFDA advisers, who met for three days over the weekend,
voted 31 to 1 to keep the drug on the market, suggesting that “it should be
available to those who need it.”
“It was clear that the benefits outweigh the risks of the drug, but the company
must abide by the ruling and place a warning on the product,” said Salah
Mawajdeh, director of the Jordanian Food and Drugs Administration (JFDA),
commenting on the panel's decision.
Mawajdeh said on Sunday that the JFDA initially warned local physicians about
the potential risks of the use of Cox-2 inhibitors, such as Celebrex, Vioxx, and
the lesser-known Bextra. “Now Celebrex will contain information warning the
consumer of the risks and benefits.”
Pfizer reportedly welcomed the “affirmation of the safety and efficiency of
their drug, as a pain management therapy,” said Ahmad Hakim, director of
external affairs and policy at Pfizer Middle East.
COX-2 pain medicines are important treatment options for arthritis patients,
“The panel's decision in this regard reaffirms the effectiveness of the drug for
millions of suffers in the region,” added Hakim.
The decisions came amid speculation that Merck's rival drug Vioxx — withdrawn
last year after studies linked it to risk of heart problems — may make a
comeback, Agence France-Presse reported.
While the advisery panel's vote is not a final decision by the USFDA, the agency
generally always heeds the recommendations of its expert panels.
Vioxx, Celebrex and Bextra have all come under fire recently for being linked to
a higher incidence of cardiac problems in some patients.
In December, the National Cancer Institute, part of the US National Institutes
of Health, stopped clinical trials investigating the use of Celebrex (celecoxib)
to prevent colon polyps because of an increased risk of cardiovascular (CV)
events in patients taking Celebrex versus those taking a placebo, according to
USFDA website.
Patients in the clinical trial taking 400mg of Celebrex twice daily had a 3.4
times greater risk of CV events compared to those taking placebo. For patients
in the trial taking 200mg of Celebrex twice daily, the risk was 2.5 times
greater. The average duration of treatment in the trial was 33 months.
These findings are similar to recent results from a study of Vioxx (rofecoxib),
which was voluntarily withdrawn from the market by its manufacturers Merck Co.
in September. The study on Vioxx showed that the drug doubled the risk of heart
attacks and strokes in patients who took it regularly for at least 18 months,
according to the USFDA.
Celebrex was approved in 1998 for the treatment of osteoarthritis and rheumatoid
arthritis. Previous major studies of the medicine, including clinical trials and
epidemiology studies, did not suggest the sort of risks found in the Vioxx
study.
During the same meeting, the panel voted 17 to 15 on Vioxx's return to the
market, but limited its sale to the lowest dose and recommended that it be a
second choice after patients try another pain reliever, Reuters reported.
Mawajdeh said it would not be surprising if Merck brings back Vioxx to the
market. “Restriction applied on Celebrex must be applied on Vioxx, which carries
the same active components,” he added.