The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling,...

The FDA now requires that product labels for the long-acting injectable progestin contraceptive medroxyprogesterone acetate (MPA; Depo-Provera CI, and generics; Depo-SubQ Provera 104) include a warning about the risk of meningioma associated with its use.

The FDA has approved a nebulized suspension of the corticosteroid budesonide for maintenance treatment of persistent asthma in children one to eight years old.

Bivalirudin is being promoted as an intravenous (IV) anticoagulant that can be used instead of heparin in patients with unstable angina undergoing coronary angioplasty.

A reader has asked us to review the choice of drugs for heparin-induced thrombocytopenia (HIT), a prothrombotic state with high morbidity and mortality. Three recent publications have made somewhat different recommendations on its treatment.

The FDA has approved dimethyl fumarate (Tecfidera – Biogen Idec), formerly called BG-12, for treatment of relapsing forms of multiple sclerosis (MS). It is the third oral drug to be approved in recent years for this indication.

Cobicistat, a pharmacokinetic enhancer that boosts levels of some HIV drugs but has no antiretroviral activity of its own, is now available alone as Tybost (Gilead) and in fixed-dose combinations with the protease inhibitors atazanavir (Evotaz — BMS) and darunavir (Prezcobix — Janssen) for treatment of HIV-1 infection. Both atazanavir and darunavir have traditionally been used in combination with the CYP3A inhibitor ritonavir (Norvir) to boost their serum concentrations, but neither is available in a fixed-dose combination with ritonavir.

View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder

The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy in adults with FLT3 internal tandem duplication (ITD)-positive, newly-diagnosed acute myeloid leukemia (AML).

Inclisiran (Leqvio – Novartis), a subcutaneously injected small interfering RNA (siRNA) that decreases LDL-cholesterol (LDL-C) levels by reducing synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9), has been approved by the FDA for use with or without a statin to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Inclisiran had previously been approved for use only in combination with statin therapy.