Question

What could have been the consequences of acomplia recall from the market? issues such as labelling changes, alternative pharmaceuticals, warnings or recall in accordance with pharmacovigilance.

Answer 1

Acomplia (Rimonabant):It belongs to Cannabinoid-1 receptor blockers.

Mechanism of action:It acts by blocking Cannabinoid receptors that found in the brain and other peripheral organs which is important for glucose and lipid metabolism, including adipose tissue,muscle and gastrointestinal tract.

• These drug will switch off the brain circuit that make people hungry when they smoke cannabis.By blockade of cannabinoid receptor acts to decrease the over activity of the endo cannabinoid system.
• Cannabinoid receptors used to regulate body weight and in controlling energy balance as well as glucose and in lipid metabolism.

Consequences to recall from the market:

• Data from the clinical trails submitted to the regulatory bodies showed that the acomplia caused depressive and mood alteration in 10% of population and sucidal thoughts is around 1% have been reported in Europe.So it is contraindicated to the psychiatric patients.
• Other adverse effects like upper respiratory tract infections in more than 10% of population.Nausea,Insomnia, Anxiety, muscle cramps, tendolitis and flu like symptoms.
• The food and drug advisory committee raisen concern about long term usage of drug cause seizures on dose of 20mg.
• The European agency recommended the suspension of these drug after the committee for medicinal product for human use will increased risk of suicidal ideas by reviewing the postmarketing survellience data in October 2008
• Food and drug administration conducted meta analysis of rominabant safety data indicate the risk for developing sucidal ideation in patient on the 2mg dose.
• Labelling changes: Advise to patients or consumers: Stop taking the medicine-Return to your physician when convenient for a review of your conditions. Return remaining packs to your pharmacist.Advise to physician do not issue any prescription for acomplia.