FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm295585.htm
Potential Signals of Serious
Risks/New Safety Information Identified by the Adverse Event Reporting
System (AERS) October - 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) | Death from intrathecal administration (medication error) | The
Dosage and Administration and Contraindications sections of the
labeling for Velcade were updated January 2012, to include fatal events
with intrathecal administration. Bortezomib (Velcade) Labeling approved January 23, 2012 (PDF - 2.22MB) |
| Brentuximab vedotin (Adcetris) | Progressive multifocal leukoencephalopathy (PML) | FDA Drug Safety Communication The Boxed Warning and Warnings and Precautions sections of the labeling for Adcetrus were updated January 2012, to include PML. Brentuximab vedotin (Adcetrus) Labeling approved January 13, 2012 (PDF - 217KB) |
| Fluoroquinolone products | Peripheral sensorimotor neuropathy | FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about peripheral sensorimotor neuropathy, is adequate. |
| Gabapentin HCl (Neurontin) | Increase in blood creatine phosphokinase levels and rhabdomyolysis | FDA is continuing to evaluate these issues to determine the need for any regulatory action. |
| Gadolinium-based contrast agents (GBCA) products | Acute kidney injury | FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about kidney injury, is adequate. |
| Iloprost inhalation solution (Ventavis) | Hemoptysis | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Loperamide HCl-containing products (Imodium) | Pancreatitis | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Magnesium sulfate for injection | Fetal skeletal demineralization, hypermagnesemia, and other bone abnormalities with continuous long-term use in pregnant women. | FDA is continuing to evaluate these issues to determine the need for any regulatory action. |
| Milnacipran HCl (Savella) | Homicidal ideation | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Pegloticase (Krystexxa) | Anaphylaxis and infusion reactions | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Phenytoin (Dilantin) and non-depolarizing neuromuscular blocking agents | Drug interactions resulting in decreased effectiveness of the non-depolarizing neuromuscular blocking agent | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Polyethylene Glycol (PEG) 3350 over-the-counter oral laxative (Miralax) | Neuropsychiatric events | FDA decided that no action is necessary at this time based on available information. |
| Proton pump inhibitors (PPIs) Over-the-counter (OTC) products | Clostridium difficile-associated diarrhea | FDA Drug Safety Communication FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Rubidium Rb 82 generator (CardioGen-82) | Unintended radiation exposure to strontium isotopes following myocardial imaging scans. | FDA Drug Safety Communication CardioGen-82 was voluntarily recalled by the manufacturer in July 2011; a return to the U.S. market is planned. The Boxed Warning, Dosage and Administration, and Warnings and Precautions sections of the labeling for CardioGen-82 were updated February 2012, to include information about unintended radiation exposure. Rubidium Rb 82 generator (CardioGen-82) Labeling approved February 8, 2012 (PDF - 465KB) |
| Sorafenib tosylate (Nexavar) | Osteonecrosis of the jaw | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Telaprevir (Incivek) | Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS) | FDA is continuing to evaluate this issue to determine the need for any regulator |
