Servier Defends Dietary Drugs

Following its joint decision with US marketing partners American HomeProducts and Interneuron to pull its dietary products based on fenfluramine and dexfenfluramine (Marketletter September 22), French drugmaker Laboratoires Servier has rejected a statement from the US Food and Drug Administration linking the drugs with heart valve disorders.

Servier's director of communications, Jerome Libiot, said: "we haven't taken our drugs off the market. We've suspended their sale," adding that the debate surrounding the drugs had become heated. The group noted that the FDA investigation lacked a control group and argues that vascular problems in the USA are more likely to be linked to a combination of fenfluramine and phentermine, the distribution of which is prohibited in Europe.

As to the financial impact of the suspension on the firm, a spokesman for Servier told the Marketletter that it is "more likely to take a couple of months, rather than a couple of weeks" to assess the full cost of the withdrawal. While the situation is being evaluated, Servier intends to continue its research on the drugs, which account for less than 8% of total European revenue, but has not set any time-scale for the resumption of marketing. Meantime, a class action has been filed in Georgia against 10 makers of fen-phen diet pills on behalf of those who have used and allegedly been hurt by them.