Sixteen Drugs Identified by AERS as Potentially Having Serious Risks
Sixteen drugs were identified by the Adverse Event Reporting System (AERS) during the fourth quarter of 2011 and have been flagged by the US Food and Drug Administration (FDA) for further review, the agency said in a statement on its website.
The products, which include Fluoroquinolone-based products, Imodium, proton pump inhibitors and Vertex's hepatitis C drug Incivik, were determined to have potential safety issues in FDA's 17 April posting.
FDA noted no causal relationships have been established between the products and the risks associated with them, but said it was looking to further evaluate the products.
If the products are determined to be positively associated with the risks, the agency said it might subject them to a range of restrictions, including labeling changes, a risk evaluation and mitigation strategy (REMS) plan or additional postmarketing study requirements.
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 |
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 | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
Loperamide HCl-containing products | 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 | Homicidal ideation | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
Pegloticase | 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 | 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) | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
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