South Africa cautious over new wonder drug
16 May 1999
Deaths in the US linked to fast-selling 'super aspirin' prescribed to relieve arthritis. LAURICE TAITZ
A POPULAR new arthritis drug is under investigation in South
Africa after several patients died in the US.
Helen Rees, the chairman of the South African Medicines and
Medical Devices Regulatory Authority, is examining the safety of
Celebrex (celecoxib), which was released in the US three
months ago. Since then it has become one of the fastest-selling
drugs in history - in just 13 weeks 2,5 million prescriptions have
been dispensed.
The "wonder drug" has received preliminary approval from the
authority but will not be registered until the death reports have
been investigated more thoroughly.
Celebrex's huge success has been attributed to the
dissatisfaction of many arthritis sufferers with the medication
previously available. It is marketed as a drug that combats
arthritic pain and inflammation without causing the stomach
ulcers associated with aspirin and ibuprofen.
But, according to an article published in the Wall Street Journal
last month, the "super aspirin" has been linked to 10 deaths and
11 cases of gastrointestinal bleeding. three months ago.
Reports on the deaths submitted to the Food and Drug
Administration claimed that five people died from gastrointestinal
bleeding, two from heart attacks, one from drug interaction and
one from a kidney disorder. The cause of death in the tenth
patient was not clear. Eight of the deceased had histories of
heart, liver or intestinal problems.
Robert de Lap, director of the administration's office of drug
evaluation, said it was difficult to evaluate the significance of
these reports because of the huge number of prescriptions.
De Lap was quoted as saying: "We won't be able to reach
conclusions about its relative safety compared with other
painkillers until more research is done."
Rees said the adverse drug reaction monitoring unit had already
contacted the manufacturer for more information.
"We will need to establish whether the five bleeding deaths in
particular were cases of cause and effect or whether the
people using the drug had previously used arthritis medication
that caused gastrointestinal damage. It could be a case of
people using their old medication with the new, but we have no
way of knowing this. We are actively investigating these cases.
"If a link to the drug is proved, a caution will be written into the
package insert."
Celebrex, which is being co-promoted by pharmaceutical giants
Pfizer and GD Searle & Company, belongs to a new generation
of drugs called Cox-2 inhibitors. Earlier painkillers used to treat
arthritis - non-steroidal anti-inflammatory drugs - have been
associated with thousands of cases of ulcers and stomach
problems. In the US about 15 000 deaths and more than 100 000
hospital cases occur each year.
Steve Geis, Searle's US vice-president for arthritis clinical
research, noted that many patients taking the drug had other
illnesses and were taking multiple medications, a factor which
may add to the side effects. In clinical trials the most common
side effects were indigestion, diarrhoea and abdominal pain.
However, less than one percent of patients found these
problems serious enough to stop treatment.
Searle responded to the Wall Street Journal article by saying the
company found no direct causality between the drug and the
deaths.
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