Interaction With Protease Inhibitors

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Concerns were also raised in 1999 of a probable interaction between sildenafil and protease inhibitors leading to a potentiation of the effects of sildenafil and an increased likelihood of adverse effects.742:3 In Europe, Pfizer and European Union regulators agreed to a sildenafil labelling change that concomitant treatment with ritonavir is not advised, and planned to expand the drug interaction precaution to include other protease inhibitors.751:2 Similarly, in the United States, the FDA and Pfizer discussed updating the labelling of sildenafil to include a warning about possible interactions with protease inhibitors.751:2

In September, the Japanese Ministry of Health and Welfare issued another warning against unregulated use of sildenafil without proper consultation with a physician.769:2 At the time, a total of 33 adverse reactions associated with sildenafil had been reported in Japan, including 2 deaths; sildenafil had been prescribed by a doctor in only 8 of the 33 cases. Also, in September, the UK Medicines Control Agency (MCA) had received 31 reports of death possibly associated with sildenafil770:2 and the French Health Products Safety Agency had received 33 such reports.775:5

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