Tredaptive modified-release tablets - withdrawn throughout the European Union

(Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)

21 January 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 04-01/13

Product details

Stock from MSD (Merck Sharp & Dohme Ltd) and Parallel Distributors

Tredaptive modified-release tablets

(Nicotinic acid and Laropiprant)

EU/1/08/459/002 and EU/1/08/459/003

Alert details

All unexpired stock of both originator and parallel-distributed packs of this product are being recalled to pharmacy, clinic and wholesaler level irrespective of batch number, expiry date and pack size.

The product is being withdrawn throughout the European Union after a study has shown a failure to reduce major vascular events and an increase in non-fatal serious adverse events. Both the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee have concluded that the benefits no longer outweigh the risks.

Our information from the European Medicines Agency indicates that one parallel-distributor, Swingward Ltd T/A Medihealth has registered as a parallel-distributor. Both originator and parallel-distributed stock is in the supply-chain and will need to be handled differently as outlined below.

No further Tredaptive tablets should be dispensed. Pharmacists should refer patients with new or repeat prescriptions to the treating physician to review their treatment plan on a non-urgent basis.

Any remaining stock of this product should be quarantined, identified as originator or parallel-distributed stock and returned to the original supplier in the normal way.

For enquiries relating to stock returns, with originator product: If you purchased Tredaptive from Alliance Healthcare Distribution Limited, they will be in contact with you shortly with details of the recall procedure. Should you have any questions, please contact your local Alliance Service Centre. If you did not purchase Tredaptive from Alliance, you should contact your supplier to arrange return.

For enquiries relating to stock returns, with parallel-distributed Swingward/Medihealth stock please call Ms Brenda Greenwood on 01204 473136.

For all medical information enquiries, please call MSD Medical Information department on 01992 467272.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

MHRA distribution

Further recipients by cascade:

Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison health policy unit (DH)
Chief pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare commission for distribution to independent health care establishments
Primary care trusts (England)

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Published 17 December 2014