France Withdraws HMR's Teldane Approval

- The French drug agency AFM has withdrawn marketing approval for ayear from Hoechst Marion Roussel's antiallergy drug Teldane (terfenadine). The agency says the drug poses the risk of "rare but grave" cardiac side effects. The European Medicines Evaluation Agency is also to examine the product. HMR has been given one month to respond before the agency decision is finalized. HMR sources have said that the risks are linked to overdosing and to interactions with other drugs including antibiotics. The drug's withdrawal under its US brand name, Seldane, has also been requested by the Food and Drug Administration (Marketletters passim). The FDA has said that there already exists another, more efficacious product - Allegra (fexofenadine) - also an HMR product.