OTC alli in French pharmacies from May 6 despite opposition from the AFSSAPS

UK-headquartered pharmaceutical major GlaxoSmithKline has found itself the target of criticism from the French Agency for the Sanitary Safety  of Health Products (AFSSAPS) over the decision to launch an  over-the-counter version of anti-obesity agent orlistat from May 6,  following approval from the European Commission in January  (Marketletter January 26).

The 60mg dose of the drug, marketed as alli, has been available in the  USA since 2007, whereas the 120 mg prescription-only version of the  compound, Xenical, has been marketed by Swiss drug major Roche for over  10 years in the European Union (Marketletters passim). The Commission  ruling applies to all 27 EU member states and represents the first  switch from a centrally-approved weight-loss treatment to OTC status.

At an AFSSAPS press conference attended by Philippe Lechat, the director  of evaluation of medicines and biologic products, and Anne Castot, the  departmental head of pharmacovigilance, both made clear the agency's  misgivings concerning the appearance of alli on the French market. They  expressed fears that people who are not obese will be tempted to "lose  two or three kilos before hitting the beaches this summer," putting  themselves at risk of potential side effects. Among the allegations  made against the OTC product by the regulator was that a "maximum"  weight loss of 5kgs is possible and that pharmacists will be tempted to  supply the drug to customers without making the necessary background  checks to ensure that the agent is suitable.