13th March 15:25
New Warnings Added to Glaxo Asthma Drugs (asthma pulmonary)
New Warnings Added to Glaxo Asthma Drugs
By Lisa Richwine
WASHINGTON (Reuters) - GlaxoSmithKline Plc's asthma drugs Serevent and
Advair will carry new warnings about a higher, though small, risk of
life-threatening asthma attacks and deaths, U.S. regulators said
The Food and Drug Administration, in a statement, stressed that the
benefits of Serevent or Advair continue to outweigh risks when used
Patients should not stop taking either drug without consulting a
doctor because abruptly halting treatment could lead to dangerous
disease flare-ups, the FDA said.
The boxed warnings follow GlaxoSmithKline's January announcement that
it had halted a large trial in which more Serevent patients
experienced life-threatening asthma episodes, including deaths, than
patients on a placebo.
In the study, 36 patients taking Serevent died from asthma or had
life-threatening attacks, compared with 23 in the placebo group, the
Closer ****ysis found black patients were more likely to experience
respiratory problems, including deaths, the FDA said.
The study did not provide enough information to show whether Serevent
caused the problems, said Dr. Kathy Rickard, GlaxoSmithKline's vice
president for respiratory, clinical development and medical affairs in
"We don't know what the cause is," she said in an interview, noting
that blacks overall are more likely to die from asthma.
She said the company agreed physicians should know about the study
findings but stressed that the new label does not recommend any
changes to prescribing directions.
"Physicians ... have extensive experience with these medicines, and
we're confident they will continue to be very important treatment
options for asthma," she said.
Both Serevent and Advair contain salmeterol, a long-acting beta
agonist that relaxes the bronchial muscles and allows patients to
breathe more easily.
Advair combines Serevent and Flovent, an inhaled steroid that prevents
asthma attacks by controlling inflammation in the lungs. Advair is
known as Seretide in Europe.
Advair's worldwide sales were $1.682 billion in the first half of
2003, and Serevent's were $369 million.
Serevent was launched on the U.S. market in 1994 for asthma, and the
company started a study in 1996 to address safety questions. The trial
was intended to enroll 60,000 patients, but was stopped after about
26,000 were treated with Serevent or a placebo. Advair was not studied
in that trial.
Serevent also is approved for treating a lung ailment called chronic
obstructive pulmonary disease.
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