Posted by: Peter | 2009/06/26

Synap Forte Dangerous??

With the withdrawal of all medicines containing the substance dextropropoxyphene in Europe yesterday, can we still consider products like Synap Forte and Lentogesic to be safe? If it is considered too unsafe for Europe, then why has this not been banned in South Africa yet? Is it safe to continue using it?

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Our expert says:
Expert ImagePharmacist

Hi Peter

The major concern of the European Medicines Agency was the ‘narrow therapeutic index’ of dextropropoxyphene. This means that the difference between the dose needed to treat the patient and the dose that could harm the patient is small.
There have been concerns for some years over the risk of death from overdose – both intentional and accidental - in patients taking medicines containing dextropropoxyphene and paracetamol. In the UK this drug were wthradwn in 2005 alredy.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of dextropropoxyphene do not outweigh its risks, and has recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).

In SA the MCC need first need to review this finding before a local decision can be made.

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