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News1990April › Gotcha: the drugs regulators pounce yet again › April 1990

Gotcha: the drugs regulators pounce yet again

Drugs regulators are our caped crusaders

Drugs regulators are our caped crusaders. They stand on guard, ever vigilant, for any problems with prescription drugs, and then they swoop, without fear and favour, on our behalf. The miscreant is removed, and we can again sleep safely in our beds.

We like to champion the deeds of these heroes in our humble e-mail missives, and we've come across yet another example of our boys in action against the pharmaceutical oligarchy.

Our story concerns a drug called Serevent (salmeterol xinafoate), a beta-agonist inhaler to treat asthma. Sudden, unexpected, deaths were soon associated with the drug, and so the manufacturer, GlaxoSmithKline, decided to mount a major trial to found out the truth. The Salmeterol Multicenter Asthma Research Trial (SMART) recruited 13,174 asthmatics into the trial, which ran for seven months until December 1996. Then silence - for six years. Finally, at the end of last year, the results were published. The drug is indeed linked to life-threatening asthma attacks and death, especially among African Americans, the findings announced.

The American drugs regulator, the Food and Drug Administration (FDA), said it was taking the matter very seriously, and immediately entered into discussions with the manufacturer.

Now, after another seven months' deliberations, the FDA has decided to. . .change the wording on the label. This type of draconian reaction will doubtless send a shock wave through the pharmaceutical industry. If anyone in future produces a drug that can kill people, then they might have to reword the label.

Not that the FDA feels anyone should stop taking the drug. They should just know it might kill them. A GlaxoSmithKline spokeswoman explained: 'Abruptly stopping medication may result in acutely deteriorating asthma control, which may be life-threatening.' This is opposed to continuing with a drug that may be, er, life-threatening.

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