Please note that Statin medications appear twice on this list.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, Second Quarter 2009
| Product Name: Active Ingredient (Brand Name) or Product Class | Potential Signal of a Serious Risk/New Safety Information | Additional Information as of December 31, 2009 |
| Aliskiren (Tekturna, Tekturna HCT) | Angioedema requiring intubation | FDA approved Valturna (an aliskiren-containing product) on September 16, 2009. Risk for angioedema was included in the Warnings and Precautions section of the labeling for Valturna. The Warnings and Precautions section of the labeling for Tekturna was updated in November 2009 to include angioedema requiring intubation. |
| Antipsychotics | Agranulocytosis | FDA has requested class labeling to add agranulocytosis to the Precautions section of the labeling for all antipsychotics. Refer to the July 2009 Drug Safety Labeling Changes summary page, listing products with "labeling for the entire class of antipsychotic drugs," on the MedWatch Web site. |
| Bumetanide (Bumex) | Serious skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrosis) | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Cisplatin (Platinol) | Leukoencephalopathy | Under FDA study |
| Deferasirox (Exjade) | Deaths | FDA issued an Early Communication about an Ongoing Safety Review on this issue in September 2009. FDA Issues Early Communication Regarding Deferasirox Safety in MDS, Sept. 2009 New Boxed Warning for Deferasirox, Feb. 2010 Under FDA study |
| Gabapentin (Neurontin) | Drug reaction with eosinophilia and systemic symptoms (DRESS) | Under FDA study |
| Imatinib mesylate (Gleevec) | Hearing disorders and hearing loss | Under FDA study |
| Immunosuppressants (transplant) | BK virus nephropathy | An FDA alert was issued in July 2009 about labeling changes for immunosuppressant drugs for this event. FDA Adds Infection Warnings to Immunosuppressant Labels |
| Natalizumab (Tysabri) | Herpes virus infections | FDA evaluated case reports in AERS and determined that the current labeling, which addresses herpes virus infections in the Warnings and Precautions and Adverse Reactions sections of the labeling, is adequate. |
| Natalizumab (Tysabri) | Pericarditis | Under FDA study |
| Oseltamivir phosphate (Tamiflu) | Hypothermia | Under FDA study |
| Riluzole (Rilutek) | Interstitial lung disease | The Warnings section of the labeling was updated November 2009 to include interstitial lung disease. |
| Simvastatin (Zocor) and Diltiazem (Cardizem) | Myopathy due to drug interaction | FDA is evaluating this issue to determine if simvastatin labeling, which includes myopathy, is adequate. |
| Ticlopidine | Disseminated intravascular coagulopathy | Under FDA study |
Potential Signals of Serious Risks/New Safety Information Identified by AERS, Third Quarter 2009
| Product Name: Active Ingredient (Brand Name) or Product Class | Potential Signal of a Serious Risk/New Safety Information | Additional Information as of December 31, 2009 |
| Alvimopan (Entereg) | Gastrointestinal perforation | FDA is studying this issue to determine the need for regulatory action |
| Bendamustine (Treanda) | Infusion site extravasation | Under FDA study |
| Dexlansoprazole (Kapidex) | Name confusion with Casodex | The FDA/CDER medication error division works closely with the Institute for Safe Medication Practices (ISMP) on some issues. Both FDA and ISMP have been evaluating this issue. The ISMP discussion of the issue is available on the ISMP Web site. |
| Doripenem (Doribax) | Seizure events, hepatic events, thrombocytopenia, serious skin reactions | Under FDA study |
| Enoxaparin (Lovenox) | Catheter thrombosis, splenic rupture | Under FDA study |
| HMG-CoA reductase inhibitors (Statins) | Cognitive effects | Under FDA study |
| Lamotrigine (Lamictal) | Central nervous system infection, aseptic meningitis | Under FDA study |
| Neuromuscular blocking agents | Anaphylactic reactions and potential for cross-reactivity | Under FDA study |
| Ramipril (Altace) | Angioedema (requiring intubation) | Under FDA study |
| Sirolimus (Rapamune) | Progressive multifocal leukoencephalopathy (PML) | Under FDA study |
| Tumor necrosis factor (TNF)-alpha blockers | Demyelinating neuropathy | Under FDA study |
| Valsartan-containing products | Angioedema (requiring intubation) | Under FDA study |
| Zonisamide (Zonegran) | Rhabdomyolysis, pancreatitis | Under FDA study |
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