The FDA Implemented a New Rule Requiring Stricter Warning Labels for Nearly 400 Drug Products

Due to the number of incidents involving improper use of prescription opioid painkillers, opioid-containing cough medicines and benzodiazepines the Food and Drug Administration (FDA) implemented some changes to the warning labels of about 400 drugs.  Opioids are prescription drugs that can help manage pain and reduce coughing; whereas, benzodiazepines are prescribed to treat anxiety, insomnia and seizure disorders.  Consequently, physicians have been prescribing opioid medications to treat a cough in patients who also take benzodiazepines to treat anxiety, which has resulted in serious side effects such as coma and death.  The new rule requires boxed warnings in order to prevent future incidents of overdose and death caused by using opioids and benzodiazepines at the same time.  As mentioned in the “FDA adds toughest warning label to nearly 400 drug products” article, “the warnings must include information about the serious risks associated with using the medications at the same time.”

The new boxed warning requirement, the strongest possible warning, is part of the larger Opioids Action Plan, which aims to stop the prescription opioid abuse epidemic.  The prescription opioid abuse epidemic is a serious public health crisis.  The article emphasized how the FDA found that “from 2004 to 2011, the rate of emergency department visits involving nonmedical use of opioids and benzodiazepines increased significantly, with overdose deaths from taking prescribed or greater-than-prescribed doses nearly tripling during that period.”  Also, “the number of patients who were prescribed both drugs increased by 41 percent between 2002 and 2014.” Thus, the abuse and misuse of both products has become widespread throughout the years. 

The FDA has taken both the findings mentioned above as well as petitions requesting box warning on all opioid and benzo products seriously and has decided to follow through with this new rule.  The response letter from the Director from the Center for Drug Evaluation and Research to Rhode Island’s Director of the Department of Health and Baltimore City’s Commissioner of Health highlighted that “because of differences in drug pharmacology, conditions of use, different risk-benefit assessments, and available data, the precise language of the new warnings for opioid analgesics, prescription opioid cough products, and benzodiazepines will vary slightly.”  

The label requirement is seen by the FDA as a crucial mechanism to inform both patients and physicians of the high risks of using the products simultaneously.  In addition to the boxed warning, the FDA issued a Drug Safety Communication, which warned health care professionals to limit prescribing both drugs and to limit the dosage of each drug if they have to be prescribed together.  The Communication also warned patients who are taking opioids with benzodiazepines to seek medical attention immediately if they or someone they know who is also taking both drugs experience any symptoms.  Even without any signs of symptoms, patients are encouraged to communicate with their provider to see if combined use is necessary.

The FDA does not want to pull these drug products off the market, but they want to ensure that patients who experience pain have access to prescription opioid painkillers.  As a result, the agency is monitoring these products and enforcing stricter warnings to prevent misuse and abuse.

Natalie Ficek is a current student at DePaul University College of Law in Chicago.  Natalie holds a Political Science Degree from DePaul University.  She has a special interest in health law and will complete her law degree and certificate in health law in 2018.