Safety Alerts & Recalls

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FDA Approves Updated Labeling For Antiepileptic Medications
The FDA has approved the updated labeling for antiepileptic medications, including levetiracetam (marketed as Keppra), used to treat epilepsy (a condition that causes seizures), psychiatric disorders, and other conditions, including migraine and neuropathic pain syndromes. This updated labeling warns about the increased risk of suicidal thoughts and behaviors (suicidality) with the use of these medications, a concern described in previous FDA safety alerts in January and December 2008. The new labeling also includes a medication guide, to be issued to patients each time levetiracetam (Keppra) is dispensed. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm
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FDA Approves Updated Labeling For Antiepileptic Medications
The FDA has approved the updated labeling for antiepileptic medications, including 0xcarbazepine (marketed as Trileptal), used to treat epilepsy (a condition that causes seizures), psychiatric disorders, and other conditions, including migraine and neuropathic pain syndromes. This updated labeling warns about the increased risk of suicidal thoughts and behaviors (suicidality) with the use of these medications, a concern described in previous FDA safety alerts in January and December 2008. The new labeling also includes a medication guide, to be issued to patients each time oxcarbazepine (Trileptal) is dispensed. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm
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Date Published Title Drug Source
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Levetiracetam FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Oxcarbazepine FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Pregabalin FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Tiagabine FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Topiramate FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Divalproex Sodium FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Zonisamide FDA
2009-05-06 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-05 New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products Hydrocodone Bitartrate with Ibuprofen FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut Ephedra Free FDA
2009-05-04 Recall on Ranbaxy's Generic Nitrofurantoin Nitrofurantoin FDA
2009-05-04 Recall on Single lot of Calan (Verapamil) 80 mg tablets Verapamil FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen with Oxycodone FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Hydrocodone with Acetaminophen FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Butalbital, Acetaminophen & Caffeine FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA