english.prescrire.org > Spotlight > Archives : 2005 > Immunostimulants, Biostim° and others: finally taken off the market

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Immunostimulants, Biostim° and others:
finally taken off the market

Drugs based on bacterial extracts and sold as "immunostimulants" have at last been withdrawn from sale, since they have no proven efficacy and can cause sometimes serious adverse effects.

Several immunostimulant drugs containing bacterial antigens have been on the market for many years and are prescribed to prevent various recurrent respiratory or oropharyngeal infections. Back in the 1990s, Prescrire pointed out that the efficacy of these drugs was similar to that of a placebo. In 2001, 315 reports of serious adverse effects or reactions which recurred on reintroduction of the drug were made during a survey carried out by the Saint-Étienne regional pharmacovigilance centre. It was not until 2005 that the French drug regulatory agency, AFSSAPS, finally recognised that the benefit-harm balance for these drugs was negative and that they caused rare, but potentially serious, adverse effects (essentially of an allergic or cutaneous nature). The decision to withdraw these products (Biostim°, Imocur°, Imudon°, IRS19°, Ribomunyl°) is laudable but long overdue: it has been several years since these drugs were shown to be ineffective and to cause serious, even fatal, adverse effects.

©Prescrire November 2005

Source: "Immunostimulants : retrait du marché français" Rev Prescrire 2005 ; 25 (266) : 747.

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