Cholesterol drug recalled over side effect fears

Lipid-lowering drug Tredaptive has been recalled by the manufacturer and doctors told to stop issuing prescriptions after a trial found a risk of serious side effects including bleeding and myopathy.

Tredaptive is being withdrawn across Europe (Photo: MSD)
Tredaptive is being withdrawn across Europe (Photo: MSD)

Tredaptive modified-release tablets (nicotinic acid/laropiprant), used to treat dyslipidaemia, are being withdrawn throughout Europe by manufacturer MSD.

A recent trial of the treatment found it failed to reduce major vascular events and increased non-fatal serious adverse events.

The MHRA said in a statement that all unexpired stock are being recalled and no further Tredaptive tablets should be dispensed.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) had concluded that the benefits of using the treatment no longer outweigh the risks.

It advised clinicians to stop prescribing the drug and review patients' treatment.

It follows the release of preliminary data from the HPS2-THRIVE study, which found patients treated with nicotinic acid/laropiprant and a statin saw no reduction in major vascular events such as MI and stroke compared with statin therapy alone.

In addition, there was an increase in serious adverse events in patients taking the drug, included intracranial and gastro-intestinal bleeding, myopathy, infections and new-onset diabetes, according to the EMA.

MSD's UK medical director, Dr Paul Robinson, said:  'While the results of the trial are disappointing, we have worked speedily with the MHRA to ensure that communications are sent to doctors swiftly. MSD remains very active in cardiovascular research and our commitment to long term clinical trials remains strong.'

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