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.

TGA Revises Dental Laboratory Product Standards

Summary —

As a result of ADIA's policy advocacy the TGA has revised the regulatory arrangements for dental laboratory products that introduce new mandatory reporting requirements and have confirmed that crowns, bridges, dentures and similar products need to meet the same design and performance standards whether made locally or overseas.

Key Issues For The Dental Industry —

The regulatory standards for laboratory work (referred to as custom-made medical devices for regulatory purposes) are enforced by the Therapeutic Goods Administration (TGA) pursuant to the provisions of the Therapeutic Goods Act (Cth) 1989. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

For more than a decade the Australian Dental Industry Association (ADIA) has been working with the TGA to ensure that dental laboratory products meet the same regulatory standards irrespective of source.

After advocacy at a parliamentary and departmental level, ADIA has been able to secure some important reforms that confirm the regulatory standards for dental laboratory products and revise the mandatory reporting arrangements. The outcome is a regulatory framework that:

  Defines the required design and performance standards; and
  Requires a local laboratory or importer to notify the TGA or their operations.

Importantly, these obligations are common to all suppliers of dental laboratory products in Australia, whether they be supplied by a local laboratory, an importing wholesaler or a dentist importing the product from overseas.

ADIA has welcomed the leadership shown by the TGA and its senior staff in working with the dental industry to deliver these important reforms that support the sector.

The reporting requirements are the result of a recent regulatory amendment secured by ADIA. Within two months of commencing local manufacturing or importing the product, there is now a requirement that the TGA be notified of the activity and, in so doing, a further requirement to provide information about the manufacturer to the TGA. Further information can be found online at:

Additional online information —

 TGA Regulatory requirements for dental laboratory products

The enclosed brochure sets out these requirements in more detail. Consistent with ADIA’s agenda of keeping red-tape to a minimum, there is only a requirement to notify the TGA when supply commences (i.e. in the first instance) and not every time a dental laboratory or importer supplies a product. ADIA’s work in this area was possible as a result of the support and guidance that we receive from members and I encourage you to consider becoming involved in ADIA’s policy advocacy activities

Member Engagement —

ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. On matters associated with regulation of dental laboratory products ADIA staff receive advice and guidance from members that belong to the ADIA-LIG Laboratory Interest Group and who serve on the ADIA-DRC Dental Regulation Committee.

Currency of Information —

This update was issued on 15 March 2016 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations.

Disclaimer —

The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 

This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated. 

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