Potential Signals of Serious Risks/New Safety Information Identified by AERS, January to March 2012
| Product Name: Active Ingredient (Trade) or Product Class | Potential Signal of a Serious Risk/New Safety Information | Additional Information (as of May 1, 2012)* |
| Immune globulin intravenous (human), 10% liquid (Privigen, CSL Behring) | Hemolysis, hemolytic anemia. The majority of cases reported have occurred in patients with non-O blood type and/or receiving doses of ≥2g/kg. | The labeling for Privigen was modified in April 2012 to include information on risk factors for hemolysis. The FDA is continuing to evaluate this issue to determine the need for any further regulatory action. |
| Iodinated contrast agent products | Thyroid dysfunction (hyperthyroidism and hypothyroidism) | The FDA is continuing to evaluate these issues to determine whether the current labeling, which contains information about thyroid dysfunction, is adequate. |
| Lacosamide (Vimpat, UCB) | Toxic epidermal necrolysis | |
| Methylergonovine maleate tablets and injection (Methergine, Novartis) | Myocardial ischemia and infarction associated with methylergonovine-induced vasospasm. Medication errors involving neonates and adults. | |
| Montelukast (Singulair, Merck) | Stevens-Johnson syndrome |
* Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.
More information on AERS and its quarterly watch list is available on the FDA's Web site.