Safety labeling updates and new warnings

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Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).

Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).

The labeling for efalizumab (Raptiva, Genentech/Xoma) was revised to include information about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (eg, cellulitis, pneumonia) despite antimicrobial treatment.

FDA issued a public health advisory to alert health-care professionals, patients, and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product (Duragesic, Janssen) and the generic product.

New labeling was issued for gefitinib (Iressa, AstraZeneca) that states the medication should be used only in cancer patients who have already taken gefitinib and whose doctors believe it is helping them.

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