European Medicines Agency told to provide details on anti-obesity drugs

European ombudsman Nikiforos Diamandouros has called on the European Medicines Agency (EMA) to grant access to clinical study reports and trial protocols for anti-obesity drugs. His demand follows a complaint from Danish healthcare researchers who wanted to conduct an independent analysis of the drugs. In 2007, the researchers, from a health and information centre, asked to see clinical study reports and corresponding trial protocols for two anti-obesity drugs. They explained that they wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common.
Read article at theparliament.com

Concerns that OTC anti-obesity drug, orlistat, brand name Alli, may cause liver damage.

Reported here: BBC News item.

Extracts from the report:

"The FDA said the most commonly reported adverse reactions included the yellowing of skin or whites of the eyes, weakness and stomach pain.

Between 1999 and 2008, the agency received 32 reports of liver damage, 30 of which occurred outside the US. Of these 27 resulted in hospitalisation.

The agency said it was now conducting a review of the safety of the drug, but stressed no definite association with liver damage had been established at this stage."

"In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said it had received a total of 1,295 suspected adverse drug reaction reports associated with orlistat, including 137 involving suspected liver damage, since it was licensed in 1998."

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The European drugs watchdog is recommending doctors do not prescribe the anti-obesity drug rimonabant, also known as Acomplia.

The European drugs watchdog is recommending doctors do not prescribe the anti-obesity drug rimonabant, also known as Acomplia. The European Medicines Agency has said the risk of serious psychiatric problems and even suicide are too high.
Read article on the BBC News website (UK)