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 | Date: March 12, 2008 |
The following new items were added to the CDRH web pages on March 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter |  |
Update : 2
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 3
Subject: Internet Drugs Falsely Claim to Prevent, Treat STDs
Internet Drugs Falsely Claim to Prevent, Treat STDs
Wed, 12 Mar 2008 16:07:00 -0500
FDA is alerting consumers about certain drugs they may have purchased on the Internet. The drugs falsely claim to prevent and treat a variety of sexually transmitted diseases, including herpes and chlamydia
Update : 4
Subject: FDA MedWatch - Prezista (darunavir)- Reports Of Drug Induced Hepatitis In Patients Receiving Prezista/Ritonavir
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FDA and Tibotec Therapeutics notified 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 during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
Read the complete 2008 MedWatch Safety Summaries including a link to the manufacturer's Dear Healthcare Professional Letter and Prescribing Information for Prezista concerning this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista
Update : 5
Subject: FDA MedWatch- Erythropoiesis Stimulating Agents- Studies Indicate Increased Mortality And More Rapid Tumor Progression In Patients With Cancer Receiving ESAs
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Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.
Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA
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