Medication Monitor

Generic Name (Trade Name—Company)
July 14, 2011

Multiple drugs

(Various trade names—Multiple manufacturers)
FDA names 14 drugs with safety signals

Based on a review of data in the Adverse Event Reporting System (AERS) between January and March 2011, FDA has compiled a list of 14 drugs with potential signals of serious risks and/or new safety information.

In its announcement, FDA noted that a potential safety issue has been identified, but that does not mean that a causal relationship between the drug and the listed risk has been identified.

The medications and their associated safety risks are as follows:

• Adalimumab (Humira): Hepatic dysfunction, failure

• Azathioprine (Imuran): Acute febrile neutrophilic dermatosis (Sweet’s syndrome)

• Cetuximab (Erbitux): corneal infection, ulcerative keratitis, and skin necrosis

• Dabigatran etexilate mesylate (Pradaxa): proper storage and handling to preserve potency

• Dronedarone HCl (Multaq): renal impairment/renal failure

• Fibrin Sealant (Tisseel VH, Evicel): graft failure in ophthalmologic procedures and lack of efficacy in neurosurgical procedures for repair of dural tears

• Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin): thromboembolic events wih numerous product lots

• Iron sucrose injection (Venofer): anaphylactic reactions

• Quinolone products: pseudotumor cerebri

• Malathion (Ovide): burns and burning sensations

• Mercaptopurine (Purinethol): hepatosplenic T-cell lymphoma

• Prasugrel HCl (Effient): hypersensitivity reactions

• Rituximab (Rituxan): hypogammaglobulinemia

• Ropinirole HCl (Requip): medications errors as a result of similarities of product name with risperidone