Safety Alerts & Recalls

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Latest Alerts

Increased risk of suicidal thoughts and behaviour
The FDA today notified healthcare professionals that a range of anti-epileptic products were associated with a significantly higher risk of suicidal thoughts and behavior (0.43% vs 0.23%) than placebo in clinical trials. This increased risk was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. These results were consistent amongst the eleven drugs studied, and although { drug_name } was NOT one of the products included in this analysis, the FDA believes that this risk is likely to be shared by all antiepileptic medications. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm
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Early communication regarding ongoing FDA review
The FDA today issued an early communication regarding new clinical data for { drug_name }. This follows the release of preliminary data from the ENHANCE trial, a study conducted in patients with heterozygous familial hypercholesterolemia (HeFH) - a condition associated with very high cholesterol levels that affects approximately 0.2 percent of the population. This preliminary data suggests that patients taking Vytorin had similar amounts of arterial plaque build-up to patients taking simvastatin alone - even though their cholesterol levels were lower. At this stage, the FDA is still awaiting the final study report from Merck/Schering-Plough, the manufacturer of { drug_name }, and anticipates further communication within 6 months once it has fully evaluated this new information. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070779.htm
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Date Published Title Drug Source
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
2008-01-17 FDA recommendation regarding use in children Pseudoephedrine FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Alendronate FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Alendronate and Vitamin D FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Tiludronic Acid FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Etidronic Acid FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Ibandronate Sodium FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Risedronic Acid FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Actonel Plus Calcium FDA
2008-01-03 FDA Communication Regarding Thyroid Medication Levothyroxine FDA
2008-01-03 FDA Communication Regarding Thyroid Medication Thyroid FDA
2008-01-03 FDA Communication Regarding New Anemia Drug Studies FDA
2008-01-03 FDA Communication Regarding New Anemia Drug Studies Darbepoetin Alfa FDA
2007-12-21 Drug information update on Fentanyl Transdermal System (marketed as Duragesic) Fentanyl FDA
2007-12-18 Recall of selected 180mg and 240mg bottles Thyroid FDA
2007-12-18 Recall of selected 5mg tablets Glyburide FDA
2007-12-04 Revised prescribing information regarding severe hyponatremia and seizures Desmopressin FDA
2007-11-27 Revised pregnancy rating Mycophenolate FDA