| Subject: | FDA Notifies Healthcare Professionals of Changes to Prescribing Information for Prezista |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 13 Mar 2008 - 01:00 am |
| FDA and Tibotec Therapeutics are notifying healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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