EMA considers changing EU rules on diet pills

Published: 12-Oct-2012
Regulatory

Over concerns that risks to patients are being underestimated


The European Medicines Agency (EMA) is consulting on potential changes to its guidance on the development and use of weight control medicines, because of concerns that risks to patients are being underestimated. It has released a consultation paper noting that given the dramatic worldwide increase in obesity and people being overweight ‘in-depth evaluation of overall benefit/risk is a crucial issue’.

One particular concern is that current EU market approval guidelines include no requirement to demonstrate the impact of these drugs on cardiovascular problems.

‘Considering some weight reducing agents may have a potentially negative influence on blood pressure, heart rate or other cardiovascular parameters, it would be essential to exclude a harmful effect before licensing’, says EMA.

Comments on the consultation should be submitted by 31 December.

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