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.