The story so far: Serevent (salmeterol xinafoate) is a beta-agonist inhaler for asthmatics. Deaths were so quickly associated with the drug following its approval that the manufacturer, GlaxoSmithKline (GSK), launched a special trial, testing the drug against a placebo.
The Salmeterol Multicenter Asthma Research Trial (SMART) ended in December 1996. It compared 42 mcg of Serevent given twice a day to 13,174 asthmatics with 13,179 patients given a placebo.
Yet, the trial results were not published until the end of 2002 – six years later. They confirmed that the drug was fatal among some users, especially African Americans.
So, for how long did the manufacturer know the trial results before announcing them? And how many people died unnecessarily from the drug because they were unaware of its possible fatal effects?
The US drugs regulator, the Food and Drug Administration (FDA), was clearly concerned by the findings, and decided to have ‘discussions’ with the manufacturer. Was the drug about to be banned? A hushed nation awaited the decision . . .
Now read on: The discussions had continued for seven months before the FDA decided to – change the wording on the label. This draconian measure has no doubt sent a shock wave through the pharmaceutical industry, leaving it with no doubt whatsoever that its drugs must not kill the patient and, if they do, the manufacturer may have to say so on the label.
Of course, the FDA continued, this does not mean that people should stop taking the drug. A GSK spokeswoman said: ‘Abruptly stopping medications may result in acutely deteriorating asthma control, which may be life-threatening’.
This is opposed to continuing drug therapy, which can be, er, life-threatening.
Patients with worsening or acute asthma shouldn’t be prescribed the drug in the first place. That really would be tempting fate.