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Viread FDA Alerts

The FDA Alert(s) below may be specifically about Viread or relate to a group or class of drugs which include Viread (tenofovir).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for tenofovir

Viread (tenofovir disoproxil fumarate)

Oct 21, 2003

Audience: Infectious Disease and other healthcare professionals

Gilead Sciences, Inc. notified healthcare professionals of a high rate of early virologic failure and emergence of nucleoside reverse transcriptase inhibitor (NRTI) resistance associated mutations observed in a clinical study of HIV-infected treatment-naïve patients receiving a once-daily triple NRTI regimen containing didanosine enteric coated beadlets (Videx EC, Bristol-Myers Squibb), lamivudine (Epivir, GlaxoSmithKline), and tenofovir disoproxil fumarate (Viread, Gilead). Based on these results, Tenofovir DF in combination with didanosine and lamivudine is not recommended when considering a new treatment regimen for therapy-naïve or experienced patients with HIV infection. Patients currently on this regimen should be considered for treatment modification.

[October 14, 2003 Letter - Gilead Sciences] PDF Format

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