June 16, 2009FDA Approves Injectable Form of Ibuprofen FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. Source: www.fda.gov Propylthiouracil Propylthiouracil (PTU)-Induced Liver Failure Source: www.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Levemir Insulin (Novo Nordisk) Patients advised to check personal supply of insulin to identify possible stolen and dangerous product. Source: www.fda.gov Sirolimus (marketed as Rapamune) FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Source: www.fda.gov # posted by Network @ 12:34 AM
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