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Fact is that these drugs, especially the cox2 inhibitor Celegrex, have been completely banned in civilized countries like the US and Germany. But NAFDAC advices us to use them only on Doctors prescription. The side effects of these drugs are so terrible that they have been completely banned, why is NAFDAC still endorsing these drugs?
NAFDAC urges caution on painkiller drugs, Celebrex, Napozen By Chukwuma Muanya, Senior Health Reporter
PATIENTS using two painkiller drugs, Celebrex and Napoxen stand a higher risk of suffering heat-related problems, the National Agency for Food and Drugs Administration and Control (NAFDAC) has said.
Consequently, the agency has alerted all healthcare practitioners and patients nationwide to use the drug only on doctors prescription.
It advised that alternatives to the drug should be sought based on individual patient's need and risk factors. And where alternatives are not available, the lowest effective dose should be administered, the agency counselled.
NAFDAC added that patients should be duly informed of the risks associated with the drugs, while any detected side-effects or Adverse Drug Reactions (ADR) should be reported to the National Pharmacovigilance Centre (NPC), at the NAFDAC office in Abuja.
Two separate letters on NPC alert for practitioners signed by the NAFDAC Director General, Professor Dora Akunyili, have been forwarded to Chief Medical Directors of 54 Federal Hospitals across the six geo-political zones of the country.
This was disclosed to The Guardian by the Special Assistant to NAFDAC's Director General, Mrs. Elizabeth U. Awagu. According to her: "Celebrex and Naproxen are prescription only drugs and the issuance of this alert is directed to the medical and other related professionals. As practised world-wide, NAFDAC exercises caution on issuing public alerts on ethical/or prescription drugs but informs practitioners accordingly."
NPC alert for practitioners on Naproxen reads: " NAFDAC wishes to alert healthcare practitioners on recent United States Food and Drug Administration (USFDA) statement on Naproxen, following the decision of the US National Institute of Ageing to halt a clinical trial studying NSAIDs in patients at risk of developing Alzheimer's disease. US-FDA preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to patients taking Naproxen.
"The NPC, NAFDAC, Abuja has also received one ADR report, on the case of tightness in the chest and weakness in a patient that used 500mg of Naproxen twice daily, orally over five days, for back pain. According to the report, adverse reaction started the same day the medication was started and stopped when the medication was stopped on the fifth day. Many brands of Naproxen are registered in Nigeria as prescription only medicine...."
The NPC alert for practitioners on Celebrex reads: "NAFDAC wishes to alert healthcare practitioners on the recent USFDA statement on the halting of a Clinical Trial of COX-2 inhibitor, Celebrex, due to information from the U.S. National Cancer Institute (NCI) and Pfizer Inc. During this trial seeking a new use of Celebrex (celecoxib) to prevent colon polps, NCI had to stop the trial because of increased risk of cardiovascular effects (including heart attack and stroke), myocardial infarction and cardiac arrythmia.
"Celebrex is the only selective COX-2 inhibitor currently registered for use in Nigeria...
"NAFDAC and even FDA are not aware of any long-term safety studies of older, COX-2 NSAIDs that address cardiovascular risk."
A recent report in the Journal of the American Medical Association had also linked the popular and heavily marketed painkiller, Vioxx, to dangerous blood clots, heart attacks, and strokes. Vioxx represents a new generation of arthritis drugs known as COX 2 inhibitors. Celebrex (celecoxib) and Naproxen are other versions of the COX 2 inhibitors.
The Guardian investigation revealed that Vioxx is not registered by NAFDAC, its registration was rejected on application due to some grey areas.
The risk of cardiovascular problems, including heart attack, stroke, sudden death and blood clots, is believed by researchers to be more than two times higher in people who used Vioxx than in the traditional, arthritis pain treatment with non-steriodal anti-inflammatory drugs and NSAIDs which are part of the Naproxen group.
This was concluded by a study that involved 8,000 patients and compared the COX-2 inhibitor Rofecoxib (Vioxx) with the traditional NSAID Naproxen.
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