NGC Update Service: U.S. Food and Drug Administration (FDA) Advisories

NGC Update Service: September 26, 2016

U.S. Food and Drug Administration (FDA) Advisories

August 31, 2016: Opioid Pain or Cough Medicines Combined With Benzodiazepines: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, their strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines.

September 7, 2016: Ovarian Cancer Screening Tests: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer.