Montelukast (Singulair) is undergoing a safety review regarding a possible association between it and behavior/mood changes, suicidality, and suicide. However, it may take up to nine months to complete the review. Other leukotriene receptor antagonists also are being evaluated (e.g., zafirlukast, zileuton).
Mycophenolate mofetil (MMF) and the ester of the active metabolite mycophenolic acid (MPA), known as Cellcept and Myfortic, have received an FDA alert regarding reports of infants born with serious congenital anomalies. These anomalies have included microtia, and cleft lip and palate. These women were taking these drugs to prevent organ rejection following transplant, however, some women were receiving the drugs to manage systemic lupus erythematosus (SLE), and erythema multiforme. These women were receiving the agents before their pregnancies and continued into the first trimester or until the pregnancy was detected. Both MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the children that received the drugs in utero.
The FDA and the manufacturer of natalizumab injection (Tysabri) have informed healthcare professionals of reports of clinically significant liver injury (e.g., markedly elevated serum hepatic enzymes, elevated total bilirubin) within six days of starting natalizumab. The agent is FDA approved to treat multiple sclerosis and Crohn’s Disease. Natalizumab should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians need to inform patients that natalizumab may cause liver injury. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a registered pharmacist based in New York City.