LONDON (MarketWatch) — GlaxoSmithKline PLC (GSK) Friday rejected the findings of a magazine article which reported that blockbuster asthma drug Advair may kill as many as 4,000 people a year.
A spokeswoman for the U.K. drug maker said the article in the current issue of Forbes magazine is “extremely irresponsible” and riddled with inaccuracies.
“The safety and efficacy of Advair are extremely well-established with regulators and physicians across the world,” she said.
The article said that around 4,000 patients may be dying each year because of one of the drug’s ingredients.
It also quoted Shelley Salpeter, a clinical professor of medicine at Stanford University, saying the drug should be recalled.
Advair, which is marketed in the U.K. as Seretide, is the fourth best-selling drug in the world, with sales rising 22% to GBP3 billion last year.
It combines two GlaxoSmithKline drugs, Serevent - whose main ingredient, salmeterol, dilates the airways - and Flovent, which reduces airway inflammation.
Last month GlaxoSmithKline reached an agreement with the U.S. regulator to update Advair’s label with a new warning advising doctors to limit the use of the drug to patients who don’t benefit from other asthma drugs, or who are severe cases.
The agreement followed a study of 26,000 patients that found a higher death rate in people treated with salmeterol.
The warning was already included on Advair’s label, but it now contains specific advice to doctors to restrict the drug to patients who really need it.
(Bloggers note- if there is any danger or doubt - the drug should be delisted. Why risk patients health over share holder gains?)