Safety Alerts & Recalls

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Latest Alerts

Boxed Warning Added to Testosterone Gel Products (Androgel, Testim)
The Food and Drug Administration (FDA) announced that it is requiring manufacturers of two prescription testosterone gel products, AndroGel 1% and Testim 1%, to include a new boxed warning. Androgel and Testim are gels applied to the skin for use in men who either no longer produce testosterone or produce it in very low amounts. The boxed warning will provide additional information about the risk of accidental exposure of another person to testosterone through contact with a person being treated with these products, also known as secondary exposure. The boxed warning will include the steps that should be taken to reduce this risk. The FDA is also requiring manufacturers to develop a Medication Guide to be dispensed with every prescription of { drug_name }. The FDA is requiring this updated labeling after receiving reports of adverse effects in children who were accidentally exposed to testosterone gel. These reports include cases of inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. In most cases, the signs and symptoms went away when the child no longer was exposed to the product. However, a few cases required additional medical monitoring or hospitalization. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm149346.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm
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FDA Approves Updated Labeling For Antiepileptic Medications
The FDA has approved the updated labeling for antiepileptic medications, including carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), 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 carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR) 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
2009-05-07 Boxed Warning Added to Testosterone Gel Products (Androgel, Testim) Testosterone FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Carbamazepine FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Felbamate FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Gabapentin FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Lamotrigine FDA
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
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