Asthma drug a killer, Senate inquiry hears: [1 All-round Country Edition]
Stapleton, John. The Australian [Canberra, A.C.T] 22 Nov 2004: 4.
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Abstract
A US trial last year involving Serevent and a dummy treatment was halted after 13 people taking Serevent died. GlaxoSmithKline was forced to place a warning on its packaging.
Doctors said Serevent was most commonly prescribed in conjunction with other drugs. The product Seretide, for example, the leading asthma preventer with 2.5million local scripts written annually, is a combination of Serevent and an anti-inflammatory.
"Our concern as paediatricians is that kids with very mild asthma are being put on Seretide as a first choice, rather than just using a non-steroidal or inhaled steroid." A company spokeswoman said: "GlaxoSmithKline stands firmly behind Serevent, which is safe and effective when used appropriately and in accordance with labelling and treatment guidelines." Three other drugs named by the FDA's spokesman as having safety concerns were on sale in Australia; Reductil, Roaccutane and Bextra.
THOUSANDS of asthma sufferers are misusing a popular treatment drug, which has been blamed for the deaths of 13 people in the US.
Australian doctors write 200,000 prescriptions a year for Serevent.
A senior member of the US Food and Drug Administration, David Graham, is pushing for a review of the research that supported the drug's approval.
"We have had cases of people dying clutching their Serevent inhalers," Dr Graham told a US Senate inquiry last week.
The share price of manufacturer GlaxoSmithKline, with more than $US4billion ($5.1billion) in annual sales from Serevent products, dropped sharply after Dr Graham's testimony.
He was responsible for exposing the linking of arthritis painkiller Vioxx to increased heart attacks, triggering its withdrawal from sale last month.
A US trial last year involving Serevent and a dummy treatment was halted after 13 people taking Serevent died. GlaxoSmithKline was forced to place a warning on its packaging.
Australia's national drug regulator, the Therapeutic Goods Administration, issued a warning here in June, based on the US research, that Serevent should be used only in combination with other drugs.
"We educate the doctors, the doctors need to ensure their patients are educated," spokeswoman Kay McNiece said. She was unable to say how many adverse reactions had been recorded in Australia but said reports would be closely monitored.
Doctors said Serevent was most commonly prescribed in conjunction with other drugs. The product Seretide, for example, the leading asthma preventer with 2.5million local scripts written annually, is a combination of Serevent and an anti-inflammatory.
John Morton, director of respiratory medicine at Sydney Children's Hospital, said some patients might use Serevent on its own because it was very effective in reducing asthma symptoms.
He said there was also increasing concern in the medical profession over the widespread use of Seretide.
"We are concerned it is being used excessively," he said. "It is a heavy-duty medication. As specialists, we would use it as our third choice, certainly in children.
"Our concern as paediatricians is that kids with very mild asthma are being put on Seretide as a first choice, rather than just using a non-steroidal or inhaled steroid." A company spokeswoman said: "GlaxoSmithKline stands firmly behind Serevent, which is safe and effective when used appropriately and in accordance with labelling and treatment guidelines." Three other drugs named by the FDA's spokesman as having safety concerns were on sale in Australia; Reductil, Roaccutane and Bextra.
Reductil, for weight-loss, is not in widespread use and has restrictions placed upon it.
Roaccutane, used for severe acne, can be prescribed only by specialists, and Bextra, an arthritis pain-relieving drug, is being reviewed.
SEREVENT
* Serevent is used as an inhaler to dilate airways of people with severe asthma.
* Should only be used in combination with other drugs.
* Made by GlaxoSmithKline, which insists it is safe.
* In a US study, among the 13,176 getting Serevent, 13 died, compared with three among the 13,179 receiving a dummy treatment.
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