France's AFSSPS health products safety agency has placedphenylpropanolamine-containing nasal decongestants on a "non-renewable prescription only" basis. The drugs, which include Pfizer's market-leader Actifed (pseudoephedrine and triprolidine) and Fournier's Humex (dextromethorphan), had been freely available at pharmacies. The move follows the US Food and Drug Administration's withdrawal in November last year of all drugs containing PPA (Marketletter November 13, 2000) from the US market, after a study suggested it could increase the risk of cerebral hemorhage.
The French decision, which has been taken on the precautionary principle and will apply to all products containing a PPA-based vasoconstrictor, is a severe blow to a sector of the self-medication market worth 700 million French francs ($91.2 million) per year. A spokesman for Fournier said that to put these agents on a prescription-only basis was to kill them off, because people with nasal congestion do not have time to visit a doctor with what is a relatively minor ailment.
Some drug majors have already decided to abandon the decongestant market. Following the FDA move, Bristol-Myers Squibb, which owns French drugmaker UPSA, withdrew from the area in several national markets, and has indicated that it does not intend to launch a non-PPA decongestant in France. However, Pfizer says it hopes to market a non-PPA drug in France after the summer holidays.
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