The FDA is proposing limiting packaging of loperamide (Imodium) to prevent the risk of abuse. Loperamide, used to treat diarrhea, is available over the counter and also as a prescription medication. In the last two years, the FDA has received reports of serious cardiac problems and even death associated with self-administration of high doses of the drug in an attempt to treat opioid withdrawal or even achieve a feeling of euphoria. High-dose loperamide has been associated with QT prolongation, torsades de pointes, or other ventricular arrhythmias, syncope, and cardiac arrest. The agency is working with manufacturers to use blister packs or other single-dose packaging and to limit the number of doses in a package. Currently, loperamide is available in bottles of 60 or 100 pills.
The FDA has approved olaparib for the treatment of metastatic breast cancer in patients with the BRCA mutation. Olaparib is the first poly (ADP-ribose) polymerase (PARP) enzyme inhibitor approved to treat breast cancer. Patients must undergo an FDA-approved genetic test called the BRACAnalysis CDx to qualify to receive the drug. Olaparib also is approved to treat advanced, BRCA-mutated ovarian cancer. Approval for BRCA-mutated breast cancer indication was based on a randomized, clinical trial of 302 patients with HER2-negative metastatic breast cancer with a germline BRCA mutation, in which the median progression-free survival for patients taking olaparib was seven months, compared to 4.2 months for patients taking chemotherapy only. Olaparib was given priority review. It is marketed as Lynparza.
The FDA has changed the indication on opioid cough and cold medications to stop their use in children < 18 years of age. Products containing codeine and hydrocodone can no longer be prescribed to children because of the potential for serious side effects, including respiratory depression and death. The agency also noted that exposure of young children to opioids may be contributing to the ongoing opioid epidemic. Last year, the FDA also banned the use of codeine for pain in children < 12 years of age. Opioid-containing cough and cold medicines also will carry a new boxed warning cautioning adult users about the risks for misuse, abuse, addiction, overdose, death, and slowed or difficult breathing.
The FDA will allow nurse practitioners (NPs) and physician assistants (PAs) to prescribe and dispense buprenorphine-containing drugs approved for opioid addiction. A trial program was launched in 2016 as part of the Comprehensive Addiction and Recovery Act (CARA), of which about 5,000 NPs and PAs participated. The agency believes that some 25,000 NPs and PAs will complete the 24 hours of training required to receive the special FDA license required to prescribe buprenorphine. Most states still will require physician supervision. The FDA believes the new rule will help more people with opioid use disorder in rural areas, which generally are underserved by addiction specialists.
Plecanatide (Trulance) has received a new indication to treat irritable bowel syndrome with constipation (IBS-C) in adults. The drug is marketed for the treatment of adults with chronic idiopathic constipation. Approval was based on two Phase III, randomized, 12-week, double-blind, placebo-controlled trials that evaluated the efficacy and safety of plecanatide in more than 2,100 adults with IBS-C. Plecanatide was superior to placebo in relieving symptoms, defined as a ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movements from baseline in the same week for at least 50% of the 12 treatment weeks. Diarrhea was the most common side effect.