FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the product's prescribing information and the new information from this meta-analysis.
Source: http://www.fda.gov/cder/drug/early_comm/cefepime.htm
Friday, November 30, 2007
Varenicline and Neuropsychiatric disorders
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Source: http://www.fda.gov/cder/drug/early_comm/varenicline.htm
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Source: http://www.fda.gov/cder/drug/early_comm/varenicline.htm
Myfortic (mycophenolic acid) Delayed-Release Tablets
Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy.
MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration. A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.
Source: http://www.fda.gov/medwatch/safety/2007/Myfortic_DHCP_Letter.pdf
MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration. A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.
Source: http://www.fda.gov/medwatch/safety/2007/Myfortic_DHCP_Letter.pdf
Flu drugs and neuropsychiatric changes.
The FDA’s Pediatric Advisory Committee has recommended changing the label of Roche’s flu medication Tamiflu to reflect the potential for neuropsychiatric adverse events, but it did not specify what changes should be made.
The relationship between Tamiflu (oseltamivir phosphate) and neuropsychiatric adverse events, including suicides, cannot be determined, the FDA said. Committee members proposed including an indication that the adverse events are sometimes fatal and adding language showing the uncertainty over the drug’s causal effect.
The committee also voted to change the labeling of GlaxoSmithKline’s (GSK) Relenza (zanamivir) to reflect an increase in adverse event reports but did not determine what the changes should be or whether the label should be the same as Tamiflu’s.
Last year, Roche revised its Tamiflu package insert to add warnings about the potential for self-injury and confusion, particularly in pediatric patients. Twenty-five patients younger than 21 years old have died while taking Tamiflu, with 21 of the cases occurring in Japan and three in the U.S. Five of the deaths came from children “falling from windows or balconies or running into traffic,” the FDA said.
Source: FDA News
The relationship between Tamiflu (oseltamivir phosphate) and neuropsychiatric adverse events, including suicides, cannot be determined, the FDA said. Committee members proposed including an indication that the adverse events are sometimes fatal and adding language showing the uncertainty over the drug’s causal effect.
The committee also voted to change the labeling of GlaxoSmithKline’s (GSK) Relenza (zanamivir) to reflect an increase in adverse event reports but did not determine what the changes should be or whether the label should be the same as Tamiflu’s.
Last year, Roche revised its Tamiflu package insert to add warnings about the potential for self-injury and confusion, particularly in pediatric patients. Twenty-five patients younger than 21 years old have died while taking Tamiflu, with 21 of the cases occurring in Japan and three in the U.S. Five of the deaths came from children “falling from windows or balconies or running into traffic,” the FDA said.
Source: FDA News
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