Serevent

[Guest guest]

Hi,

the article below is confusing, to say the least. Those of you who give

their kids Serevent should contact your docs and ask what they think about

it.

Peace

Torsten, dad of Fiona 5wcf

e-mail: torstenkrafft@...

FDA Issues Warning On Asthma Drug

January 24, 2003

WASHINGTON (AP) -- The Food and Drug Administration warned Thursday that

some patients using a popular asthma medication are more likely to face

life-threatening complications and more likely to die from their

symptoms than those who are not taking the drug.

Officials emphasized that problems from the drug Serevent were rare, and

they said the drug's benefits outweigh the risks. They cautioned that it

is dangerous to abruptly stop taking the drug and recommended that

concerned patients talk with their doctors.

Serevent, an aerosol spray made by GlaxoKline, opens the airwaves

to help asthma patients breathe more easily. Patients use it twice a day

to prevent attacks.

Due to concerns about the drug, Glaxo launched a large study to compare

the number of life-threatening experiences, such as intubations and

mechanical ventilation, and the number of asthma-related deaths in

patients taking the drug vs. the number of such occurrences in patients

given a placebo.

The study found a greater risk of problems and a greater risk of death

among black patients, and found a disparity in deaths among those who

were not using a companion drug aimed at controlling inflammation.

As a result, the company and the FDA are emphasizing existing guidelines

that say asthma patients whose disease is severe enough to require daily

medication should also be using inhaled corticosteriods, which control

inflammation.

" Someone who needs Serevent should be on something to control

inflammation too, " said Dr. J. Meyer, director of one of the

FDA's offices of drug evaluation.

The study was not designed to determine why certain Serevent patients

were more likely to suffer problems, but rather to see if Serevent

itself posed a threat, Meyer said.

The 28-week study included 26,000 patients. Originally designed to

enroll 60,000 patients, Glaxo ended it early because of difficulty

finding participants and because it was not designed to analyze the

questions raised early in the study, company and FDA officials said.

When entering the study, 47 percent of all patients were using a

corticosteroid. Black patients were less likely to be using these drugs

than whites were, and that may explain at least part of why blacks using

Serevent were more likely to have lung problems and more likely to die

than whites were.

Officials at the company and the FDA did not know if other factors

contributed to the racial disparities. Due to socioeconomic and other

factors, blacks are more likely to face health problems. Overall, the

severity of asthma is worse among blacks than whites.

Neither Glaxo nor FDA officials would say precisely how many people in

each group had complications and how many died.

An estimated 16 million people in the United States have asthma, and

about 1.3 million use Serevent.

The FDA approved Serevent, also known as salmeterol xinafoate, to treat

asthma in 1994 and later extended its approval for treatment of chronic

obstructive pulmonary disease.