The US Food and Drug Administration (FDA) is announcing final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health care professionals to take a more patient-centered approach when prescribing opioid analgesic products.
In Apr 2023, FDA notified application holders of New Drug Applications and Abbreviated New Drug Applications of required safety labeling updates needed for immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics. The required safety labeling updates, originally listed in an Apr 2023 Drug Safety Communication, include the addition of language stating:
- the risk of overdose increases as the dosage increases for all opioid pain medicines;
- IR opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate;
- many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and
- it is recommended to reserve ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.
The required updates also include a new warning about opioid-induced hyperalgesia (OIH), a condition in which opioid use causes an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia). The warning also includes information on differentiating OIH symptoms from those of opioid tolerance and withdrawal.
FDA’s approval of these labeling updates is a testament to the agency’s continuing progress towards implementing the FDA Overdose Prevention Framework, which provides its vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-safety-labeling-changes-opioid-pain-medicines
In Hong Kong, there are registered pharmaceutical products containing buprenorphine (4 products), codeine (353 products), fentanyl (16 products), morphine (15 products), oxycodone (14 products) and tramadol (42 products). These products are pharmacy-only medicines or prescription-only medicines. There is no registered pharmaceutical product containing hydrocodone, hydromorphone and oxymorphone. While the FDA’s announcement did not highlight any specific adverse event, so far, the Department of Health (DH) has received adverse drug reaction related to codeine (4 cases), fentanyl (6 cases), morphine (11 cases), oxycodone (2 cases) and tramadol (9 cases). The DH has not received any case of adverse drug reaction related to buprenorphine.
Related news on the safe and appropriate use of opioid analgesics was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 11 Sep 2013, with the latest update posted on 14 Apr 2023. Letters to inform local healthcare professionals were issued by the DH on 11 Sep 2013 and 14 Apr 2023. In Feb 2015, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that pharmaceutical products which are controlled-release, extended-release or long-acting opioid analgesics (containing hydromorphone, morphine, oxycodone, oxymorphone, tapentadol, fentanyl, buprenorphine and methadone) should include safety information about the risks of addiction, abuse, misuse, overdose and death, and limitations of use in patients with severe pain for which alternative treatment options are inadequate.
The risks of tolerance, dependence, withdrawal symptoms and respiratory depression associated with the use of opioid analgesics, and the risks associated with using opioid analgesics in conjunction with benzodiazepines or other medicines that depress the central nervous system are documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference” and “AHFS Drug Information”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Dec 20, 2023
Issued at HKT 15:30
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