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Weight loss drug approval raises concerns

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Weight loss drug approval raises concerns

BEUC NEWS - 19.02.2015

Mysimba, a weight loss drug, was given the European Medicines Agency (EMA)’s green light for sale within Europe in December 2014. However, The European Consumer Organisation (BEUC) continues to highlight that the drug’s long-term safety has not been established and its effectiveness is negligible.

Mysimba’s potential adverse effects include seizures, hypertension, gastrointestinal disruption, insomnia, restlessness, joint pain and headaches. The estimated performance level is 5% weight loss over 6 months, provided the patient in conjunction gets professional counselling and leads a healthy lifestyle.

The European Commission has the final word on EMA’s decision. Therefore BEUC wrote a letter to its health directorate, DG SANTE, urging it to scrap the marketing authorisation and underlining the many weight management medicines similar to Mysimba which have been withdrawn from the market in recent years.

While the European Parliament has no veto power, EU Member States can make a difference. Our member organisations OCU, CECU (Spain), DECO (Portugal), Test-Achats (Belgium), Forbrugerrådet Tænk (Denmark) and Altroconsumo (Italy) have alerted their national authorities.

The European Commission’s final decision is expected to be made public in March.

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Communications Department

The European Consumer Organisation
Europäischer Verbraucherverband
Bureau Européen des Unions de Consommateurs

Pauline Constant, BEUC
Pauline Constant
Director, Communications