Apr29
FDA Puts 16 Drugs on Watch List
Potential Signals of Serious Risks/New Safety Information Identified by AERS, October to December 2011 – http://www.medscape.com/viewarticle/762205?src=mp&spon=38
.
| 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.