Drugs
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between October - December 2011
The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period October - December 2011 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
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.
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 1, 2013) |
|---|---|---|
Bortezomib | 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. |
Brentuximab vedotin | Progressive multifocal leukoencephalopathy (PML) | FDA Drug Safety Communication |
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 | 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) | 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 | Hemoptysis | The Adverse Reactions section of the labeling for Ventavis was updated April 2012, to include hemoptysis. Iliprost inhalation solution (Ventavis) Labeling approved April 26, 2012 (PDF - 377KB) |
Loperamide HCl-containing products | Pancreatitis | FDA decided that no action is necessary at this time based on available information. |
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 | Homicidal ideation |
The Adverse Reactions section of the labeling for Savella was updated December 2012, to include aggression, anger and homicidal ideation. Milnacipran HCl (Savella) Labeling approved December 6, 2012 (PDF - 504KB) |
Pegloticase | Anaphylaxis and infusion reactions | The Warnings and Precautions section of the labeling for Krystexxa was updated April 2012, to include anaphylaxis and infusion reactions. Pegloticase (Krystexxa) Labeling approved April 16, 2012 (PDF - 146KB) Milnacipran HCl (Savella) Labeling approved December 6, 2012 (PDF - 504KB) |
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 | Neuropsychiatric events | FDA decided that no action is necessary at this time based on available information. |
Proton pump inhibitors (PPIs) | Clostridium difficile-associated diarrhea | FDA Drug Safety Communication |
Rubidium Rb 82 generator | Unintended radiation exposure to strontium isotopes following myocardial imaging scans. | FDA Drug Safety Communication 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 | Osteonecrosis of the jaw | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
Telaprevir | Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS) |
A Boxed Warning for serious skin reactions including DRESS, SJS and Toxic Epidermal Necrolysis (TEN) was added to the labeling for Incivek December 2012, as well as updates to the Warnings and Precautions and Adverse Reactions sections of the labeling describing these issues. Telaprevir (Incivek) Labeling approved December 14, 2012 (PDF – 496KB) |
