english.prescrire.org > Spotlight > Archives : 2009 > Pharmaceutical quality: also an issue in Europe

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2009 : 1 | 30 | 60 | 90

Pharmaceutical quality: also an issue in Europe

In Switzerland, a production flaw resulted in the contamination of a drug by a potentially carcinogenic substance.

Nelfinavir became available once again at the end of 2008, having been withdrawn from the European market in 2007 due to a manufacturing defect. This decision followed the discovery that some batches had been contaminated by high doses of a substance that can cause genetic mutations.

According to the European Medicines Agency (EMEA), this contamination took place during the manufacture of nelfinavir in a tank that had not been properly cleaned. This Swiss factory’s failure to comply with best manufacturing practice had escaped detection both by the company and by the drug regulatory agencies. It was the patients, surprised at the drug’s unusual smell, who raised the alarm.

This case is a reminder that safety guarantees linked to industrial drug manufacturing procedures have their limitations, and not only in the pharmaceutical industry in the southern hemisphere, as the spokespersons for the companies in the north would have us believe.

Prescrire deplores the fact that the European Medicines Agency stopped monitoring the patients who had taken the contaminated nelfinavir after one year. Rigorous monitoring of patients exposed to hazardous substances should not be confined to reassuring short-term toxicity reports.

©Prescrire February 2009

Source: "Nelfinavir : de retour, après un sérieux défaut de qualité pharmaceutique en Suisse" Rev Prescrire 2009; 29 (303): 13.

- More articles in Prescrire's "Spotlight"...