The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H₃)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H₃-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.

Ecamsule (terephthalylidene dicamphor sulfonic acid), the first new sunscreen agent to be approved by the FDA in 18 years, is now available in the US in a moisturizer called Anthelios SX. Ecamsule has been used in Canada and Europe for more than 10 years.

The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C inhibits coagulation, increases fibrinolysis and has anti-inflammatory properties. FDA approval of Xigris (for patients with severe sepsis at high risk of death) was based on a single study (PROWESS).2 Post-marketing studies found a...

A Medical Letter reader asked about the use of the nutritional supplement 5-hydroxytryptophan (5-HTP) for treatment of depression. It is sold in health food stores, pharmacies and on-line for many indications including depression, mood enhancement, emotional well being, and promotion of normal sleep.5-HTP is the intermediate metabolite in the biosynthesis of serotonin from L-tryptophan.1 Many small studies in the 1970’s and 1980’s found 5-HTP helpful in the treatment of depression, but a Cochrane Review of 108 studies in patients with depression or dysthymia using 5-HTP or L-tryptophan...

The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a higher risk of thromboembolism than CHCs containing other progestins.1The new warning was based partly on an unpublished, FDA-funded, retrospective study that found a 1.7-times higher risk of venous thromboembolism among US women who used a CHC that contained drospirenone than among women whose CHC contained levonorgestrel, norgestimate or norethindrone as the progestin component.2 As with all retrospective...

News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine injection auto-injector) are the only other epinephrine auto-injectors currently available in the US. According to Impax (the manufacturer of both the brand and generic products), Adrenaclick is no longer being manufactured; the generic product will continue to be marketed after supplies of Adrenaclick are depleted. Auvi-Q (Sanofi), an epinephrine auto-injector that was approved by the FDA in...

The FDA has required a new boxed warning in the label of the subcutaneously injected immunomodulatory drug glatiramer acetate (Copaxone, Glatopa, and generics) about a risk of anaphylaxis. Glatiramer has been used for years to treat relapsing forms of multiple sclerosis (MS).

Mivacurium chloride (Mivacron - Burroughs-Wellcome), a short-acting nondepolarizing neuromuscular blocking drug, is now available in the USA for intravenous use in routine intubation and short procedures requiring skeletal muscle relaxation. It can be given in a bolus or a continuous infusion.

Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert), folate...

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for symptomatic relief of noninfectious diarrhea in patients with HIV taking antiretroviral drugs. It is the first drug approved for relief of antiretroviral-induced diarrhea and the first oral botanical drug approved by the FDA.