Safety Alerts & Recalls

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Latest Alerts

Public health advisory on the proper use of Tussionex
The FDA issued an public health advisory today regarding the safe and correct us of Tussionex Pennkinetic Extended-Release Suspension. The alert follows numerous reports of serious problems - including death - associated with the misuse of this medication. Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours ("extended-release"). Too much hydrocodone, particularly when used in combination with chlorpheniramine, can cause life-threatening breathing problems and death. The alert emphasizes that patients SHOULD NOT take this medication more frequently than every 12 hours, and SHOULD NOT take more than the recommended dose. It also emphasizes that this medication SHOULD NOT be used in children less than 6 years old, for whom this medication is not approved. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm
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Public health advisory on the proper use of Tussionex
The FDA issued an public health advisory today regarding the safe and correct us of Tussionex Pennkinetic Extended-Release Suspension. The alert follows numerous reports of serious problems - including death - associated with the misuse of this medication. Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours ("extended-release"). Too much hydrocodone, particularly when used in combination with chlorpheniramine, can cause life-threatening breathing problems and death. The alert emphasizes that patients SHOULD NOT take this medication more frequently than every 12 hours, and SHOULD NOT take more than the recommended dose. It also emphasizes that this medication SHOULD NOT be used in children less than 6 years old, for whom this medication is not approved. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm
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Date Published Title Drug Source
2008-03-11 Public health advisory on the proper use of Tussionex Tussionex Pennkinetic FDA
2008-03-11 Public health advisory on the proper use of Tussionex FDA
2008-02-27 Risk of Clinically Significant Liver Injury Natalizumab FDA
2008-02-13 Recall of fentanyl patches Fentanyl Manufacturer
2008-02-08 Early communication regarding FDA safety review Onabotulinumtoxina FDA
2008-02-08 Early communication regarding FDA safety review Rimabotulinumtoxinb FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Carbamazepine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Felbamate FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Gabapentin FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Lamotrigine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Levetiracetam FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Oxcarbazepine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Pregabalin FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Tiagabine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Topiramate FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Divalproex Sodium FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Zonisamide FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Phenytoin FDA
2008-01-27 Early communication regarding ongoing FDA review Ezetimibe with Simvastatin FDA
2008-01-18 Product label updated with new information about VTE risk Ortho Evra FDA