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Ferumoxytol Approved to Treat Iron Deficiency Anemia in Chronic Kidney Disease
Ferumoxytol injection may be more effective than oral iron for anemic patients in all stages of chronic kidney disease.
News, July 2009
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Insulin Glargine Potentially Associated With Increased Cancer Risk
The increased risk has been seen in 3 of 4 observational studies, but these findings warrant further follow-up studies to confirm an association, according to the FDA.
News, July 2009
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Chantix and Zyban to Receive Boxed Warnings for Serious Neuropsychiatric Symptoms
Varenicline and bupropion are receiving boxed warnings regarding the risks for changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.
News, July 2009
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FDA Safety Changes: Prevpac, Arava, Treanda
The FDA has approved safety labeling revisions for a prepackaged regimen of lansoprazole, amoxicillin, and clarithromycin tablets; leflunomide tablets; and bendamustine HCl intravenous infusion.
News, July 2009
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FDA Approves Prescription-Only Generic Plan B for Girls 17 Years and Younger
The FDA has approved the first generic version of levonorgestrel 0.75-mg tablets, which will be available by prescription only to women aged 17 years and younger.
News, June 2009
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FDA Safety Changes: Kerlone, Meridia, Stromectol
The FDA has approved safety labeling revisions for betaxolol HCl tablets (Kerlone), sibutramine HCl monohydrate capsules (Meridia), and ivermectin tablets (Stromectol).
News, June 2009
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Dexamethasone Intravitreal Implant Approved for Retinal Vein Occlusion
The FDA has approved a dexamethasone 0.7-mg intravitreal implant for the treatment of macular edema after branch retinal vein occlusion or central retinal vein occlusion.
News, June 2009
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Diclofenac Oral Solution Approved for Migraines in Adults
The FDA has approved diclofenac potassium for oral solution for the acute treatment of migraine attacks with or without aura in adults aged 18 years or older.
News, June 2009
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FDA Safety Changes: Minipress, Letairis, Coly-Mycin M Parenteral
The FDA has approved safety labeling revisions for prazosin HCl capsules (Minipress), ambrisentan tablets (Letairis), and colistimethate injection (Coly-Mycin M Parenteral).
News, June 2009
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Diclofenac Liquid-Filled Capsules Approved for Pain Relief
The FDA has approved diclofenac potassium liquid-filled soft gelatin capsules for the relief of mild to moderate acute pain in patients aged 18 years and older.
News, June 2009
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Ongoing Analyses Suggest Cefepime Does Not Increase Death Risk
In contrast to previous findings, cefepime does not appear to increase the mortality risk compared with other similar antibiotics; manufacturer and FDA studies to investigate this issue are ongoing.
News, June 2009
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FDA Safety Changes: Sarafem, Mavik, Cordarone
The FDA has approved safety labeling revisions for deferasirox tablets for fluoxetine HCl (Sarafem tablets), trandolapril (Mavik tablets), and amiodarone HCl (Cordarone tablets).
News, June 2009
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FDA Urges Caution in Interpreting Study Linking Stimulants to Increased Risk for Sudden Death in Children
A case-control study finds that methylphenidate is associated with a 6- to 7-times increased risk for sudden death in children; the FDA cautions that the study should not be used to stop these medications.
News, June 2009
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FDA Approves Ibuprofen Injection to Treat Pain and Fever
The FDA has approved an injectable formulation of ibuprofen (Caldolor) for the treatment of pain and fever. The product will be available for hospital use only.
News, June 2009
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FDA Warns of Increased Mortality Risk for Sirolimus in Liver Transplantation
The FDA has issued a safety alert warning of an increased mortality risk in once-stable liver transplant patients who are converted from a CNI-based immunosuppressive regimen to sirolimus.
News, June 2009
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FDA Expert Panel Approves Use of Atypical Antipsychotic Drugs in Kids
An FDA expert panel has endorsed claims of efficacy and acceptable safety for several atypical antipsychotic drugs for the treatment of schizophrenia and bipolar mania in children and teens.
News, June 2009
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High-Dose Melphalan Granted Orphan Drug Status for Neuroendocrine Liver Metastases
The FDA has approved orphan drug designation for melphalan infusion in the treatment of patients with neuroendocrine tumors metastatic to the liver.
News, June 2009
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FDA Safety Changes: Exjade and Extraneal
The FDA has approved safety labeling revisions for deferasirox tablets for oral suspension (Exjade) and icodextrin peritoneal dialysis solution (Extraneal).
News, June 2009
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High-Concentration Capsaicin Patch Granted Orphan Drug Designation for PHN
The FDA has approved orphan drug designation for a high-concentration capsaicin dermal patch (Qutenza) for the treatment of pain associated with postherpetic neuralgia.
News, June 2009
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FDA Approves Tacrolimus for Use With MMF in Kidney Transplant Recipients
The FDA has approved an expanded indication for tacrolimus (Prograf), recommending its use with MMF for the prophylaxis of organ rejection in allogenic kidney transplantation.
News, June 2009
