Baltimore Health Commissioner: New FDA Labeling Requirement Can Save Lives

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If my patient were in a car accident and experiencing neck pain, I might have prescribed an opioid — such as Percocet or Vicodin — for the pain, and a benzodiazepine — such as Xanax or Valium — to help treat muscle spasms. I might have prescribed to someone who is on benzodiazepines for their anxiety disorder an opioid for pain relief; and vice versa.

As an emergency physician, I have seen how often patients are prescribed opioids and benzodiazepines together. This is not based on any scientific efficacy, but common clinical practice. This is not done out of bad intention, but routine and habit.

ADVERTISEMENTEither one of these medications, when used in excess, can cause slowed breathing and sleepiness, leading to loss of consciousness and death. When used together, opioids and benzodiazepines are an especially deadly combination, increasing the likelihood of a fatal overdose.

As a public health official, I have noted an alarming trend: nearly one in three unintentional overdose deaths in the U.S. from prescription opioids also involve benzodiazepines.

In my state of Maryland, in 2014, benzodiazepines were associated with 19 percent of prescription opioid deaths. At the same time, 59 percent of benzodiazepine-associated deaths involved prescription opioids.

That’s why my colleagues and I — health officials representing 13 cities, 15 states, and 2 U.S. territories — submitted a first-of-its-kind citizen’s petition in February, calling upon the Food and Drug Administration (FDA) to change its policies to help us protect the health and well-being of our patients. 

In response, FDA announced earlier this week that it will now require a boxed warning – its highest risk communication — and updated patient medication guides to warn providers and patients about the risks of using benzodiazepines and opioids at the same time. These changes will affect nearly 400 products.

To be clear, this is not a ban on either opioids or benzodiazepines. There are instances where it is appropriate to use these medications. Instead, this warning is a powerful educational tool that offers important guidance to clinicians and information for patients that will help us in this fight to stop overdose deaths and protect our communities.

By taking swift action to answer our petition, FDA demonstrated that it is listening to everyday citizens and public health leaders. This incredible display of democracy-in-action provides those of us serving on the frontlines of the opioid epidemic with the education we need to make a difference and save lives.

According to the Center for Disease Control and Prevention (CDC), more than 28,000 people lost their lives to an opioid overdose in 2014. We can prevent death by equipping health care providers and their patients with the knowledge to make a more informed decision about the medications they prescribe and take. These warning labels might also reduce the number of prescription opioids given to patients, which in turn could mean fewer people who become addicted, overdose, and die from them.

FDA’s action is the definition of upstream intervention, and demonstrates the true purpose and power of public health.

There is much work ahead of us. To clinicians: I urge you to heed this black box warning and reconsider this potentially dangerous combination of opioids and benzodiazepines and to help us spread the word to your patients.

To patients: I urge you to look inside our medicine cabinets, and to ask important questions. What is this medication for? Do I need it? What are the side effects? Could there be a dangerous combination?

To our leaders in Congress and across all levels of government, I urge you to consider other ways that we can work to end the opioid epidemic and save lives. We must improve access to treatment so that those who are addicted can find their way to recovery. Let’s provide funding so that those of us on the ground can connect those in need with services to ensure their wellbeing. And finally, let’s all work to end the stigma associated with addiction because it is a disease, not a moral failing.

I look forward to working with the FDA and all of our partners in the health professional and patient and consumer communities to educate, change clinical practice, and save lives.

Dr. Leana Wen is the commissioner of health in Baltimore City. Twitter: @DrLeanaWen and @BMore_Healthy.


The views expressed by contributors are their own and not the views of The Hill. 

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Source : http://thehill.com/blogs/pundits-blog/healthcare/294292-baltimore-health-commissioner-new-fda-labeling-requirement-can

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