The news that Boots has decided to withdraw the heart drug Manoplax because it was killing patients received massive media coverage just recently.
What was less widely reported, however, was that it took the company nearly three months after serious doubts about the drug’s safety were first raised to take it off the market. Way back in April (as we reported two issues ago), it became clear that those taking Manoplax for congestive heart disease were more likely to die or need hospitalization than those on a placebo.
As we said in WDDTY Vol 4 No 3: “A preliminary study of 3500 patients taking 100mg of the drug shows that they ‘have a significantly increased risk of death compared to those not receiving the drug,’ Boots admits.”
At the time, however, Boots expressed every confidence in the future of the drug and maintained that on the basis of the study Manoplax was perfectly safe at the lower dose of 75mg. The drug was only dangerous at the higher dose.
Now, of course, having taken a further look at this very same study, Boots concedes that those taking 75mg of Manoplax are more likely to be hospitalized than those taking placebo. Furthermore, Mike Gates, head of pharmaceuticals public relations at Boots, admitted that when the study results were extrapolated to the 50mg dose which is prescribed in the UK a similar trend was seen.
But why were British doctors prescribing doses of 50mg, anyway? The May issue of the Drugs and Therapeutics Bulletin reports: “In the originally recommended doses of up to 150mg Manoplax possibly improved symptoms; we can find no evidence it has this effect at the new recommended lower dosage of 50mg.” Boots has not disclosed how many more people ended up in hospital in the intervening three months before the company withdrew the drug.