The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

View the Comparison Table: Drugs for Alzheimer's Disease Dementia

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.

At the beginning of this year, The Medical Letter reviewed Monoclate (Armour), a new, highly purified antihemophilic factor (AHF) prepared by immunoaffinity chromatography (Medical Letter, 30:1, 1988). Monoclate is more highly purified than older Factor VIII concentrates, but whether the combination of monoclonal antibody purification and dry heat used in preparing Monoclate will be adequate to prevent transmission of hepatitis and HIV infection remains to be established. Twenty-eight patients previously untreated with Factor VIII concentrate who have received Monoclate for periods...

The FDA, which recently approved subcutaneous (SC) administration of denosumab (Prolia – Amgen) for treatment of postmenopausal osteoporosis,1 has now approved the same drug with a different brand name (Xgeva – Amgen) and dosage for prevention of skeletal-related events (such as pathologic fracture, spinal cord compression or radiation to bone) in patients with bone metastases from solid tumors. Denosumab is a fully human anti-RANK ligand antibody that inhibits the formation, activation and survival of osteoclasts.2A prospective, randomized, double-blind trial in 1901 patients with bone...

A Medical Letter reader has asked us to review the safety of the fluoroquinolone antibiotic levofloxacin (Levaquin – Ortho-McNeil-Janssen), which has just been approved for generic use by the FDA and has been at the center of some recent lawsuits regarding the adequacy of its safety warnings.

An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.The manufacturer’s application for this new indication was based on a double-blind, randomized trial (SHARP) that compared the combination of ezetimibe 10 mg and simvastatin 20 mg with placebo in 9270 patients with chronic kidney disease who did not have a history of myocardial...

The FDA has approved a 0.016% gel formulation of the nitrogen mustard mechlorethamine (Valchlor – Actelion) for second-line topical treatment of patients with stage IA or IB mycosis fungoides, the most common type of cutaneous T-cell lymphoma. Topical nitrogen mustard has been used off-label for decades for this indication, usually as a pharmacy-compounded ointment, but no clinical trials evaluating its efficacy and safety have been done. Mechlorethamine is also available in an injectable formulation (Mustargen – Recordati) for the same and other indications.FDA approval of Valchlor was...

The FDA has approved Duopa (Abbvie), a carbidopa/levodopa enteral suspension, for treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). It has been available in Europe since 2001.In patients with advanced PD, emptying of the stomach may be delayed and unpredictable, which can affect the rate and amount of absorption of carbidopa/levodopa and its efficacy. To bypass the stomach, the new formulation is delivered through a nasojejunal (NJ) tube or percutaneous endoscopic gastrostomy with jejunal (PEG-J) tube.A randomized, double-blind, active-controlled, 12-week...

The FDA has approved two new drugs for treatment of specific subtypes of acute myeloid leukemia (AML).Vyxeos (Jazz Pharmaceuticals) is a liposomal fixed-dose combination of daunorubicin and cytarabine, the standard drugs used for induction treatment of AML. It is approved for induction and consolidation treatment in adults with newly diagnosed chemotherapy- or radiation-related AML or AML with myelodysplasia-related changes. Patients with these subtypes of AML have a poor prognosis. The rationale for development of the combination was that nano-scale liposomal drug delivery vehicles prolong...