Archive | August, 2009
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
UPDATE 08/31/2009 - Supplemental Q&As added to 08/04/2009 safety information (increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers).
Continue reading...Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
28. August 2009
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FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Precautions added to prescribing information.
Continue reading...Intelence (etravirine)
27. August 2009
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Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions.
Continue reading...Levemir Insulin (Novo Nordisk)
26. August 2009
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[UPDATED 08/26/2009] Stolen vials of Levemir still may be on the market. FDA received multiple reports of patients who suffered adverse events due to poor control of glucose levels after using vial from stolen lots.
Continue reading...Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
25. August 2009
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Voluntary recall classified as Class 1 due to the reasonable probability that use of these products will cause serious injury or death.
Continue reading...Steam Dietary Supplement
24. August 2009
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[UPDATED] Nationwide recall expanded, new lot added due to undeclared drug ingredient.
Continue reading...Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
24. August 2009
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FDA is reviewing reports of serious liver injury, including liver failure.
Continue reading...Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]
24. August 2009
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Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection.
Continue reading...Ibuprofen (Unapproved) topical drug products
21. August 2009
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The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.
Continue reading...FDA Alerts and Warnings
18. August 2009
Learn more about FDA alerts and warnings here.
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31. August 2009
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