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Viread FDA Alerts

The FDA Alerts below may be specifically about Viread or relate to a group or class of drugs which include Viread.

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.

Recent FDA Alerts for Viread

Viread (tenofovir disoproxil fumarate)

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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