FDA Actions
The FDA has added a boxed warning to all immediate-release opioids regarding serious risks of misuse and abuse, which can lead to addiction, overdose, and death. The warning includes a recommendation that the drugs only be used for severe pain for which alternative treatment options are inadequate. There also is guidance on initial dosage and dosage changes, with a warning not to abruptly stop treatment in a physically dependent patient. Pregnant women should be warned that opioids put their newborns at risk for neonatal opioid withdrawal syndrome.
The FDA has eased restrictions on mifepristone used with misoprostol used for medical abortions. The new FDA-approved regimen may be used to end pregnancy through day 70 of gestation (after the start of the last menstrual period). Previously, labeling was only approved up until day 49. The dose has also been lowered to 200 mg of mifepristone orally (down from 600 mg) followed 24 to 48 hours later by misoprostol 800 mcg buccally. The new regimen requires a visit with a healthcare provider to prescribe the medication and follow-up 7-14 days later vs the previously required three visits. The new FDA-approved regimen is in line with medical literature and has been the approved regimen in many states.
The FDA has approved reslizumab for the maintenance treatment of severe asthma in patients ≥ 18 years of age with asthma exacerbations despite usual care. Reslizumab is a humanized interleukin-5 antagonist monoclonal antibody produced in murine myeloma non-secreting 0 cells. It is given by IV infusion every 4 weeks in a clinical setting prepared to manage anaphylaxis. Safety and efficacy were established in four double-blind, randomized, placebo-controlled trials in patients with severe asthma on standard therapy. Compared to placebo, reslizumab-treated patients had fewer asthma attacks and longer time to first attack, as well as significant improvement in lung function measured by FEV1. Serious side effects include hypersensitivity reactions, which can be life-threatening. Other side effects listed by the FDA are cancer and muscle pain. Reslizumab is marketed as Cinqair. Pricing has not been announced.
The FDA has approved ixekizumab for the treatment of adults with moderate-to-severe plaque psoriasis. The new drug is a humanized IgG4 monoclonal antibody that targets the IL-17A cytokine, a different mechanism of action than currently available biologic agents used to treat psoriasis. This is the second IL-17A antagonist after secukinumab. It is given as a subcutaneous injection every 2 weeks for seven doses, then every 4 weeks. Safety and efficacy were established in three randomized, placebo-controlled clinical trials of nearly 4000 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. Ixekizumab resulted in greater clinical response than placebo with skin that was almost clear on standard psoriasis scoring scales. The drug is an immunosuppressive and comes with the medication guide regarding risk of infection or autoimmune side effects. Ixekizumab is marketed as Taltz. It is priced at $4130 per dose (80 mcg).
In this section: boxed warning to all immediate-release opioids; eased restrictions on mifepristone used with misoprostol used for medical abortions; reslizumab for the maintenance treatment of severe asthma; and ixekizumab for the treatment of adults with moderate-to-severe plaque psoriasis.
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