Question
Information on the recall of nelfinavir (Viracept)
27 June 2007. Related: All topics, Changing treatment, Side effects.
I just heard from my clinic that I have to return to the clinic because of a problem with nelfinavir.
How serious is this? Where can I get more information on the recall of nelfinavir (Viracept)
Answer
Earlier this month, Roche, the manufacturers of the formulation of nelfinavir (Viracept) that is distributed in Europe, issued letters to doctors to change patients using nelfinavir to an alternative drug.
This is because some batches of nelfinavir were found to have higher quantities of a toxic substance.
If you live in the UK or Europe (or other parts of the world that uses nelfinavir manufactured by Roche) then you will have to change your combination because this formulation has been recalled and will not be available for the foreseeable future.
If your clinic has not contacted you already, please contact your doctor as soon as possible.
More information on this recall will become available over the next few weeks, including details of a safety monitoring programme for people who have been used the contaminated drug.
Although there are very few studies that can determine the level of risk involved.
The highest-dose risk is estimated as being less than one hundredth of the drug levels that showed toxicity in mice studies.
However, the importance of safety and monitoring is being taken extremely seriously by the regulatory agency in Europe and by the manufacturer.
More information about the nelfinavir recall is at these two links:
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