FDA Requires New Labeling Changes to Secure Patient Safety Regarding Combined Use of Opiods and Benzodiazepines
by Laura Johnson, on September 8, 2016
This past week, the FDA announced that as part of its Opiods Action Plan it is "requiring class-wide changes to drug labeling." The changes are being enacted to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and benzodiazepines.With this new mandate, drug manufacturers will be required to provide boxed warnings and patient Medication Guides for nearly 400 separate products. These new warnings must provide information about the serious risks of combined use of opiod analgesics, opioid-containing cough products, and benzodiazepines. The risks include extreme sleepiness, respiratory depression, coma and even death.
This is an alarming concern considering both the use of opiods and benzodiazepines are on the rise. American Society of Addiction Medicine (ASAM) reported that in 2014 2.1 million people had an opiod substance use disorder. Opiods are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief.
Additionally, an article in Sicence of Us entitled "The Scary Rise of Benzo Overdoses," reports that one in 20 Americans has a prescription to a benzodiazepine. They also noted that benzos such as Valium, Xanax, and other prescription medications which are integral to combating anxiety, mood disorders, and insomnia can be highly addictive and therefore carry a significant risk of overdose.
FDA reports that the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014. This translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf, M.D.
FDA is requiring manufacturers of the relevant products to submit labeling changes within 30 days after notification by letter. Due to the scope of changes being made to the labels of the opioid analgesics, prescription opioid cough medications, and benzodiazepines, FDA is posting example letters that best capture the breadth of the announced safety labeling changes being required.
Pharmacuetical companies looking to meet evovling regulatory manadates should consider a comprehensive Enterprise Labeling approach, which enables dynamic, data-driven labeling that offers flexibilty, consistency and accuracy. For more on Enterprise Labeling for pharmaceutical companies check out the on demand webinar with Ferring Pharmaceuticals.