Sexual dysfunction
Flibanserin (Addyi) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. The animal data suggest moderate risk. The simultaneous use of alcohol increases the risk of severe hypotension and syncope. The drug is available only through a restricted program called the Addyi REMS Program.
Immunomodulator
The new immunomodulator is secukinumab (Cosentyx). It is a human interleukin-17A antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy of phototherapy, adults with psoriatic arthritis, and adults with active ankylosing spondylitis. The animal data suggest low risk.
Lysosomal acid lipase deficiency treatment
Sebelipase (Kanuma) is a lysosomal cholesteryl ester and triacylglycerol-specific enzyme that is indicated for the treatment of lysosomal acid lipase deficiency. The animal data suggest low risk.
Parathyroid hormone
Parathyroid hormone (Natpara) is used as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathryoidism. The animal data in one species suggest moderate risk. Moreover, because of the risk of osteosarcoma, the drug should be used only in patients who cannot be well controlled on calcium and active forms of vitamin D alone.
Pyrimidine analog
Uridine (Xuriden) is a pyrimidine analog for uridine replacement. It is indicated for the treatment of hereditary orotic aciduria. The animal data suggest low risk.
Respiratory agents
The two respiratory agents are mepolizumab (Nucala) and selexipag (Uptravi). Mepolizumab is an interleukin-5 monoclonal antibody. It is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype. The animal data suggest low risk. Selexipag is a prostacyclin receptor agonist that is used for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization. The animal data suggest low risk.
Lactation
Use of the above drugs during human lactation has not been reported. It is likely that many of these agents will be excreted into breast milk. If a new agent is being taken by a woman who is or will be breastfeeding, the drug’s product information should be checked for the most common adverse reactions noted in nonpregnant patients and the nursing infant should be monitored for these effects.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He has no relevant financial disclosures.