FDA puts 16 Drugs on Watch List

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The US Food and Drug Administration (FDA) has issued its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information in the agency’s Adverse Event Reporting System (AERS) database during the last 3 months of 2011.

Potential signals of serious risks/new safety information identified by AERS, October to December 2011

. Potential signals of serious risks/new safety information identified by AERS, July to September 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)
Adalimumab

Golimumab

Optic neuritis The Warnings and Precautions section of the labeling for adalimumab and golimumab was updated December 2011 to include optic neuritis.
Clevidipine butyrate intravenous emulsion Hypoxemia (decreased oxygen saturation) The Adverse Reactions section of the labeling for clevidipine butyrate intravenous emulsion was updated December 2011 to include decreased oxygen saturation.
Dabigatran etexilate mesylate Bleeding events, including hemorrhage with fatal outcome The Dosage and Administration section of the labeling for dabigatran was updated January 2012 to include information about monitoring renal function in patients taking dabigatran and adjusting dose if necessary because dabigatran’s anticoagulant activity and half-life are increased in patients with renal impairment.

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Diazepam injection (Valium) Propylene glycol toxicity
Infliximab Sarcoidosis The Adverse Reactions section of the labeling for infliximab was updated October 2011 to include sarcoidosis.
Topical analgesic nonprescription monograph products containing menthol, methyl salicylate, and capsaicin Application site burns FDA is continuing to evaluate this issue to determine whether the current labeling for the monograph products is adequate.
Orlistat Kidney stones FDA is continuing to evaluate this issue to determine whether the current labeling for orlistat, which includes kidney stones, is adequate to address other kidney-related adverse events.

The Warnings and Precautions and Adverse Reactions sections of the labeling for Xenica (the prescription orlistat product) were updated January 2012 to include increases in urinary oxalate.

The European Medicines Agency is also evaluating orlistat for this potential risk.

Valproate products: valproic acid, divalproex sodium, valproate sodium Liver failure and injury (involving hereditary mitochondrial disorders, such as Alpers-Huttenlocher syndrome and other conditions)
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 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 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 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 Hemoptysis
Loperamide HCl–containing products Pancreatitis
Magnesium sulfate for injection Fetal skeletal demineralization, hypermagnesemia, and other bone abnormalities with continuous long-term use in pregnant women
Milnacipran HCl Homicidal ideation
Pegloticase Anaphylaxis and infusion reactions
Phenytoin 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 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 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 Osteonecrosis of the jaw
Telaprevir Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS)