Latest FDA Drug Warnings

Here is the list of drugs that now have extra warnings:

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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