FDA to require boxed warnings on opioid medications

FDA to require boxed warnings on opioid medications

 

March 22, 2016 Rockville, Md. — As part of the government's commitment to ending the U.S. opioid epidemic, the Food and Drug Administration announced March 22 major label changes for all prescription opioid products, including new boxed warnings about the serious risks of misuse, abuse, addiction, overdose and death.

The FDA also said it will require several more safety labeling changes to include additional information on the risk of these medications as part of the agency's efforts to "help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain," according to an FDA release.

"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids," said Robert Califf, M.D., FDA commissioner. "Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic."

Opioid pain medications, such as hydrocodone and oxycodone, are a leading source of drug abuse in the United States. As prescribers of these painkilling medications, the ADA believes dentists have a role to play in preventing their diversion, misuse, and abuse. The ADA has long encouraged continuing education about the appropriate use of opioid pain medications in order to promote both responsible prescribing practices and limit instances of abuse and diversion.

According to FDA, prescription opioids are divided into two main categories: immediate release products intended for use every four to six hours; and extended-release/long-acting products, which are primarily intended to be taken once or twice a day.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

Additionally, in the March 22 Drug Safety Communication, FDA outlined its plans to require labels to include safety information about opioids and their potentially harmful drug interactions with other medicines. This includes a serious central nervous system condition called serotonin syndrome as well as information on the effects opioid abuse can have on the endocrine system, including a rare but serious disorder of the adrenal glands and decreased sex hormone levels androgen deficiency.

The agency also said it is "carefully reviewing" all available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids.

In October 2015, the White House announced a multi-agency initiative aimed at combatting opioid abuse and other forms of drug abuse. The Association has pledged to provide training on opioid prescribing in the next two years as part of the American Medical Association Task Force on this issue. To date, more than 66,000 providers have completed prescriber training, putting the task force on pace to meet that goal, according to the release.

For more information about opioids, including upcoming webinars and prescriber tips, visit ADA.org/opioids.

World Oral Health Day: Five things you should know about THE POWER OF A SMILE!

To mark World Oral Health Day 2016 on Sunday 20 March the British Dental Health Foundation want to make sure everybody understands the enormous power that lies behind a smile.

We want you to take a moment and think about how a simple smile can be one of the most powerful tools at our disposal… and we all have one.

So to help everyone understand the power of a smile we have put together some of our favourite facts about smiles:

  • Charles Darwin who was one of the first to really look at the power of a smile. He noted that smiling is truly universal, unlike other physical actions such as body language, or verbal communication, which differs from culture-to-culture, we all understand a smile and the feelings behind it.
  • Smiles are hugely infectious.  So even if we don't feel much happier straight away, by smiling the people around us are more likely to smile, and that can then improve our mood as well.
  • A smile can really have a big effect our relationships.  More than half of people make a smile one of the first things that people notice about others and one of the most attractive features people can have.
  • A smile can also benefit our professional life too. A smile is seen as friendly and trustworthy; interviewers are likely to find candidates far more appealing if they go for a job interview with smile on their face.
  • It really is easier to smile too. I am sure you would have heard that it takes less muscles to smile than frown, this really is true 43 to frown and only 17 to smile!

World Oral Health Day is an excellent opportunity to let you know about the power of smile and discuss how important vitally oral health can be to our confidence, happiness and health.

You may have heard recent press about the amount of children with oral health problems. New statistics revealed more than 33,000 children were admitted to hospital for tooth extractions under general anaesthetic in the last year alone.

We cannot let poor oral health stop our children from smiling!

It's important that we are all aware of the correct way to look after our oral health to make sure maintain our smiles.

Looking after our smile should be quite simple, if you make sure you follow our three key messages:

  • Brush your teeth last thing at night and on at least one other occasion with a fluoride toothpaste.
  • Cut down on how often you have sugary foods and drinks.
  • Visit your dentist regularly, as often as they recommend.

Try to share a smile, not just on World Oral Health Day but every day, and bring a bit of happiness to those around you.

World Oral Health Day is celebrated every year on 20 March. It is an international day to celebrate the benefits of a healthy mouth and to promote worldwide awareness of the issues around oral health and the importance of oral hygiene to looking after everyone old and young.

It is a day for us to have fun – this should be a day full of activities that make us laugh, sing and smile!

To find out more about World Oral Health Day visit www.worldoralhealthday.com