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New safety warnings on immediate-release opioids

The FDA issued required new classwide safety labeling changes for immediate-release (IR) opioid pain medications that include a new boxed warning on labeling regarding the risks of misuse, abuse, addiction, overdose, and death. The FDA is taking these steps as part of an effort to reassess its approach to opioid medications, focusing on policies aimed at reversing the epidemic while still providing patients in pain access to effective relief.


The agency is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications-part of the FDA's effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.


FDA cites risk of heart failure for diabetes medications containing saxagliptin and alogliptin

An FDA safety review has found that type 2 diabetes mellitus (T2DM) medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are indicated-with diet and exercise-to lower blood glucose levels in adults with T2DM.


As a result, the agency is adding new warnings to the labels of certain drugs, including:


* saxagliptin (Onglyza)


* saxagliptin and metformin extended release (Kombiglyze XR)


* alogliptin (Nesina)


* alogliptin and metformin (Kazano)


* alogliptin and pioglitazone (Oseni).



The FDA evaluated two large clinical trials in patients with heart disease. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medications were hospitalized for heart failure compared with patients who received placebo. In the saxagliptin trial (16,492 patients), 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received placebo. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial (5,380 patients), 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group.


The FDA recommends that healthcare providers consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. Other diabetes medications may be needed if a patient's blood glucose levels are not well controlled with current treatment.

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FDA approves a single tablet regimen for HIV-1

Gilead Sciences, Inc. announced that the FDA has approved emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg (Odefsey) for treating HIV-1 infection in specific patients. Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients age 12 and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL.


Odefsey is also indicated as replacement for a stable antiretroviral regimen in virologically suppressed patients (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to Odefsey's individual components. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL/minute.

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Odefsey is not recommended in patients with an estimated creatinine clearance less than 30 mL/minute. Numerous drug interactions are associated with the components of Odefsey; prescribers should consult the complete product label for full prescribing information. Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.