Raxar Linked to Seven Deaths in Europe, U.S.
L O N D O N, Oct. 28 — British pharmaceutical company Glaxo Wellcome said Wednesday it was pulling one of its antibiotic drugs from the market after it was linked to seven deaths.
The drug, Raxar, is used to treat illnesses such as pneumonia, bronchitis and some sexually transmitted diseases.
A number of patients who used the drug suffered irregular heartbeats and loss of consciousness, the company said. Seven died from this condition — five in Germany, one in the United States and one in France.
Since it was launched in 1997, nearly 2.7 million patients have been prescribed Raxar, also sold under the brand name Vaxar.
Surprise at the FDA
Glaxo is withdrawing the drug immediately from the 36 countries where it is prescribed,
the company said. The United States and Germany are the drug’s largest markets.
Alternative medicines are available for illnesses treatable with
Raxar.
Glaxo’s decision surprised the U.S. Food and Drug
Administration, which said Wednesday it had not yet decided whether the drug was too risky
to continue selling to Americans.
Raxar can cause irregular heartbeats because of a problem called
“prolonged QT interval.” The QT interval is the time between when the left
ventricle begins to beat and when it is ready to beat again. When this interval is too
long, life can be threatened.
‘Minimal Risk’
for Most
When the FDA approved the drug in 1997, doctors knew it could prolong QT interval, but did
not know if the problem was large enough to endanger patients, FDA antibiotics chief Dr.
Sandra Kweder said. The FDA ordered Glaxo to continue studying Raxar even as it sold.
Preliminary results of that study showed that higher doses of
Raxar significantly increases QT interval, Kweder said. However, at the dose most patients
use, it seemed to be a “minimal risk,” she said.
Because the drug is not a major product for Glaxo, industry
analysts did not expect the company to suffer financially from its decision to pull it
from the market. Glaxo earned $17 million in Raxar sales last year, compared to $1.25
billion from its anti-ulcer drug, Zantac.
Even so, Raxar is the latest of several setbacks for Glaxo.
Company patents for Zantac and another top-selling drug, Zovirax,
expired in 1997, and the company lost $1.3 billion in sales to generic competitors last
year.
Also, Britain’s Health Ministry this month refused to pay
for prescriptions of Glaxo’s new influenza drug, Relenza, despite the company’s
claim that not authorizing the payments would have a devastating impact on future research
and business. 