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MSD recalls Tredaptive over safety fears

Clinical The lipid-lowering drug has been withdrawn from sale after European Medicines Agency findings showed the drug's benefits "no longer outweighed the risks".

MSD has recalled all stock of the cholesterol-lowering drug Tredaptive after research showed the drug led to an increase in "non-fatal serious adverse events".

In a drug alert yesterday (January 21), the MHRA said the manufacturer had withdrawn the lipid-lowering drug from sale throughout the EU, after the European Medicines Agency concluded the drug's benefits "no longer outweighed the risks".

Tredaptive failed to reduce major vascular events, according to preliminary findings from a clinical trial of 25,673 patients, published in December. There was also a "statistically significant increase" in adverse events among patients who had taken Tredaptive rather than a statin therapy, it found.

The trial found that Tredaptive failed to reduce major vascular events and noted a 'significant increase' in adverse events

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Preliminary analysis suggested the adverse events fell into the blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin categories.

MSD said it was "committed" to working with regulatory agencies around the world to suspend availability of Tredaptive.

The MHRA warned against dispensing Tredaptive and urged pharmacists to refer patients with new or repeat prescriptions for the drug back to their doctor. Pharmacists who purchased the drug through Alliance Healthcare should receive details of its recall procedure shortly, it added.

Tredaptive contains nicotinic acid and laropiprant and is usually taken in combination with a statin.

For medical information enquiries, call the MSD medical information department on 01992 467272.


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