Safety Alerts & Recalls

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Latest Alerts

Antipsychotics Linked With Sudden Cardiac Death
A recent study published in the New England Journal of Medicine suggests that the risk of sudden cardiac death is similar among all of the antipsychotics, including both newer and older antipsychotics. These medicines have a "black box warning" relating to an increased risk of death in elderly patients with dementia-related psychosis. This new study suggests that this risk may apply to patients of all ages taking an antipsychotic. For more information please visit: http://content.nejm.org/cgi/content/short/360/3/225
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New FDA Warning on Seizure Medications
In a follow up to the safety review conducted earlier in 2008, the FDA will change the label for antiepileptic medications, such as { drug_name }, to include a warning that use of these medications increases the risk of suicidal thoughts and behaviors (suicidality). This new warning includes all antiepileptic drugs including those used to treat epilepsy as well as depression, bipolar depression, migraines, and other conditions. For more information please visit: http://www.fda.gov/cder/drug/advisory/antiepileptics.htm
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Date Published Title Drug Source
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Trifluoperazine MediGuard CRT
2008-12-17 New FDA Warning on Seizure Medications FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Trimethobenzamide Manufacturer
2008-08-04 Generic Manufacturer Recalls Several Drug Products Trimipramine Manufacturer
2011-02-07 Watson Informs Customers of Important Information About Alcohol Prep Pads in Trelstar Kits Triptorelin FDA
2009-08-21 Recall of Single Lot of Mucinex DM Tussin DM FDA
2008-03-11 Public health advisory on the proper use of Tussionex FDA
2008-03-11 Public health advisory on the proper use of Tussionex Tussionex Pennkinetic FDA
2010-11-29 McNeil Issues Another Recall: Tylenol Cold Multi-Symptom Liquid Products Tylenol Cold Multisymtom Plus Coug Manufacturer
2011-08-16 McNeil Recalls Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps Tylenol Cold Multisymtom Plus Coug Manufacturer
2008-08-04 Generic Manufacturer Recalls Several Drug Products Manufacturer
2008-08-04 Generic Manufacturer Recalls Several Drug Products Ursodiol Manufacturer
2008-09-18 FDA Stops Imports of Ranbaxy Products Valacyclovir FDA
2010-09-16 FDA Announces New Pediatric Dosing Guidelines for Valcyte Valganciclovir FDA
2011-04-25 Novartis Pharmaceuticals Recalls Single Lot of Diovan (Valsartan) 160 mg Valsartan FDA
2007-11-20 FDA reviewing cases of suicidal ideation and occasional suicidal behavior Varenicline FDA
2009-07-01 New Boxed Warning For Chantix (Varenicline) Varenicline FDA
2011-06-16 FDA Warns: Chantix (varenicline) May Increase the Risk of Heart Attack, Angina and Other Heart-Related Adverse Events in Patients with Cardiovascular Disease Varenicline FDA
2011-07-07 Chantix: New Study Links Drug to Heart Problems Varenicline MediGuard CRT
2011-10-24 FDA Issues Safety Review Update on Chantix and Mental Health Adverse Effects Varenicline FDA
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