Boots withdraws heart drug less than a year after launch: Trial on 3,000 patients shows link with higher death rate

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The Independent Online
A DRUG to treat heart failure was withdrawn yesterday, less than a year after its launch. A trial had shown that it was linked with a higher death rate and more hospital admissions.

Doctors who have prescribed the drug, Manoplax, are advised to start patients on alternative treatments. Boots, which makes it, said it was being withdrawn voluntarily after a two-year trial of 3,000 patients in the United States and Scandinavia suggested an adverse effect on survival. Boots shareholders attending their annual meeting this week will be told the company faces costs of about pounds 200m on the drug, with a likely redundancy charge of pounds 10m- pounds 15m.

The latest data from the trial showed an 'increase in hospitalisations' in patients who took a 75mg tablet daily. Mike Gates, head of pharmaceuticals public relations at Boots, said that when the results were extrapolated to the 50mg dose which is prescribed in this country, a similar trend was seen.

Preliminary results from the same trial published in April showed that patients on 100mg daily were more likely to die than those who did not take the drug. The 100mg tablets were withdrawn but Boots had remained confident that Manoplax would prove safe at lower doses.

Mr Gates was unable to provide figures showing how many people took the drug here, nor how many deaths were associated with it. 'It is impossible to say how many have died because you are talking about people who are very close to death anyway, ' he said.

Manoplax, also known as flosequinan, was launched in the UK in September 1992 as a treatment of last resort for patients with congestive heart failure who did not respond to other drugs. It improved and strengthened the heart's action. US approval for it was given in March this year.

It is unusual for a drug to be withdrawn so quickly after its launch, but the decision was not unexpected. The company's share price initially rose yesterday, amid relief that there would be no further research and development associated with it. Manoplax cost about pounds 100m to develop over 12 years, and about pounds 20m was spent on promoting and marketing it.

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