Nelfinavir

The to nelfinavir is a drug Antirétroviral used for the treatment of the infection by HIV. They is inhibiters of proteases (IP). This molecule is marketed under the name of Viracept .

Medical alarm of June 8th, 2007

The French Agency of public health of the health products (AFSSAPS) and the Laboratoires Rock, which market to nelfinavir it ( Viracept ) in Europe, required of all the patients taking this treatment to contact their doctor. The presence of an undesirable substance, detected in several batches of Viracept, requires a change of treatment as quickly as possible. It is not the active substance of the drug which is in question ( to nelfinavir ) but a problem of manufacture of this drug. In certain countries (the United States, Canada, and Japan) where Pfizer is responsible for the production and the distribution of the product, no problem detected ace and no medical alarm declared.

Detail of the problem of manufacture

Abnormally high rates of an undesirable substance - the éthyl mésylate - were found in several batches of Viracept. The éthyl mésylate should not aps be found atrates higher than 1 ppm in Viracept. In 2007, certain batches of end products had rates of éthyl mésylate going up to 920 ppm. The éthyl mésylate is known as being carcinogenic in the animal. No data at the man is available. According to the Roche laboratories, which are based on studies in the animal, the éthyl mésylate has a toxic amount-threshold, in on this side which the toxicity of the éthyl mésylate would not be observed. According to Rock always, no patient could have been exposed with amounts approaching this amount-threshold. This assumption was not confirmed by the authorities to date.

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