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FDA Puts 16 Drugs on Watch List

Potential Signals of Serious Risks/New Safety Information Identified by AERS, October to December 2011 –


Product Name: Active Ingredient   (Trade) or Product Class Potential Signal of a Serious   Risk/New Safety Information Additional Information (as of   February 15, 2012)*
Bortezomib (Velcade, Takeda) Death from intrathecal   administration (medication error) The Dosage and Administration and   Contraindications sections of the labeling for bortezomib were updated   January 2012 to include fatal events with intrathecal administration.
Brentuximab   vedotin (Adcetris,   Seattle Genetics) Progressive multifocal   leukoencephalopathy (PML) The Boxed Warning and Warnings and   Precautions sections of the labeling for brentuximab were updated January   2012 to include PML.
Fluoroquinolone products Peripheral sensorimotor neuropathy FDA is continuing to evaluate this   issue to determine whether the current labeling, which contains information   about peripheral sensorimotor neuropathy, is adequate.
Gabapentin HCl (Neurontin, Pfizer) Increase in blood creatine   phosphokinase levels and rhabdomyolysis
Gadolinium-based   contrast agents products Acute kidney injury FDA is continuing to evaluate this   issue to determine whether the current labeling, which contains information   about kidney injury, is adequate.
Iloprost inhalation solution (Ventavis, Actelion   Pharmaceuticals) Hemoptysis
Loperamide HCl–containing products   (Imodium,   McNeal Consumer Healthcare) Pancreatitis
Magnesium sulfate for injection Fetal skeletal demineralization,   hypermagnesemia, and other bone abnormalities with continuous long-term use   in pregnant women
Milnacipran HCl (Savella, Forest   Pharmaceuticals) Homicidal ideation
Pegloticase (Krystexxa, Savient   Pharmaceuticals) Anaphylaxis and infusion reactions
Phenytoin (Dilantin, Pfizer) and   nondepolarizing neuromuscular blocking agents Drug interactions resulting in   decreased effectiveness of the nondepolarizing neuromuscular blocking agent
Polyethylene glycol 3350   over-the-counter oral laxative (Miralax,   MSD Consumer Care) Neuropsychiatric events FDA decided that no action is   necessary at this time on the basis of available information.
Proton-pump   inhibitor over-the-counter (OTC) products Clostridium difficile-associated   diarrhea
Rubidium Rb82   generator(CardioGen-82,   Bracco Diagnostics) Unintended radiation exposure to   strontium isotopes after myocardial imaging Rubidium Rb82 generator was voluntarily   recalled by the manufacturer in July 2011; a return to the   US market is planned. The Boxed Warning, Dosage and   Administration, and Warnings and Precautions sections of the labeling for   rubidium Rb82 generator were updated February 2012 to include information   about unintended radiation exposure.
Sorafenib tosylate (Nexavar, Onyx   Pharmaceuticals) Osteonecrosis of the jaw
Telaprevir (Incivek, Vertex   Pharmaceuticals) Serious skin reactions, including   drug reaction with eosinophilia and systemic symptoms (DRESS) and   Stevens-Johnson syndrome (SJS)

*Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.


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