Safety Alerts & Recalls

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Latest Alerts

FDA reviewing cases of suicidal ideation and occasional suicidal behavior
The FDA has notified healthcare professionals today about reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken { drug_name } to quit smoking. The role of { drug_name } in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and can also aggravate underlying emotional problems. However, not all patients described in the cases had preexisting emotional problems and not all had discontinued smoking. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm
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Voluntary recall of 600mg and 800mg tablets
Ranbaxy has initiated a voluntary recall of its generic 600mg and 800mg GABAPENTIN tablets (a generic version of NEURONTIN). This product may contain impurities that exceed specifications. For more information, please visit: http://fdanews.com/newsletter/article?issueId=11006&articleId=101127
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Date Published Title Drug Source
2007-11-20 FDA reviewing cases of suicidal ideation and occasional suicidal behavior Varenicline FDA
2007-11-16 Voluntary recall of 600mg and 800mg tablets Gabapentin Manufacturer
2007-11-14 New additions to black box warning Rosiglitazone FDA
2007-11-14 New additions to black box warning FDA
2007-11-14 New additions to black box warning Metformin with Rosiglitazone FDA
2007-11-14 Early Communication about an Ongoing Safety Review Cefepime FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Darbepoetin Alfa FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Epoetin Alfa FDA
2007-10-25 Early Communication about an Ongoing Safety Review FDA
2007-10-24 Updated label regarding allergic reactions and psychiatric symptoms Modafinil FDA
2007-10-16 Suspected association with acute pancreatitis Exenatide FDA
2007-10-12 Voluntary recall of OTC cough and cold medicines for infants Pseudoephedrine Manufacturer
2007-10-01 Early communication of ongoing safety review Alendronate FDA
2007-10-01 Early communication of ongoing safety review Alendronate and Vitamin D FDA
2007-10-01 Early communication of ongoing safety review Etidronic Acid FDA
2007-10-01 Early communication of ongoing safety review Ibandronate Sodium FDA
2007-10-01 Early communication of ongoing safety review Pamidronate Disodium FDA
2007-10-01 Early communication of ongoing safety review Risedronic Acid FDA
2007-10-01 Early communication of ongoing safety review Actonel Plus Calcium FDA