Recent Opioid Discontinuations and Withdrawals
Opioid product withdrawals from the market are complex events driven by various factors, including regulatory scrutiny, abuse potential, and manufacturer decisions. Keeping track of these changes is crucial for patient safety and effective pain management. Several significant opioid products have been discontinued or voluntarily withdrawn in recent years, impacting patients and prescribers globally.
Fentanyl Lollipops (Actiq, Fentora) Voluntarily Withdrawn
In September 2024, manufacturers of fentanyl lollipops, including brand names such as Actiq and Fentora, announced they would cease all promotion and sales. This decision followed years of regulatory scrutiny and legal challenges regarding inappropriate marketing and off-label prescribing, which contributed to high addiction rates. These transmucosal immediate-release fentanyl (TIRF) products were intended for opioid-tolerant cancer patients with breakthrough pain, but their misuse in non-tolerant individuals increased risks. Prescribers were advised to transition patients to non-TIRF treatments following the withdrawal agreement.
Oral Opioids Discontinued in Australia (MS Mono, Sevredol, Dilaudid, Jurnista)
In early 2024, Australia's Therapeutic Goods Administration (TGA) announced the discontinuation of several widely used oral opioid products. This included MS Mono and Sevredol (morphine sulfate) products, though alternatives are available. Dilaudid (hydromorphone) oral liquid was discontinued in August 2021, with intermittent global supply of alternatives. Jurnista (hydromorphone) prolonged-release tablets were also discontinued in April 2023, requiring special access schemes for alternatives. These discontinuations have created challenges for Australian pain patients.
Historical Landmark Opioid Withdrawals
Several significant opioid withdrawals in the past have reshaped the market and prescribing practices:
- Original OxyContin (2013): The FDA removed the original OxyContin formulation from the U.S. market in 2013 due to its high potential for abuse. Purdue Pharma replaced it with a tamper-resistant version to deter crushing and other methods of misuse.
- Reformulated Opana ER (2017): Manufacturer Endo International voluntarily withdrew reformulated Opana ER (oxymorphone) in 2017 at the FDA's request. This action followed an outbreak of HIV and hepatitis C linked to individuals injecting the manipulated drug.
- Darvon and Darvocet (2010): The FDA requested the withdrawal of propoxyphene-containing medications Darvon and Darvocet in 2010 due to evidence of serious, potentially life-threatening heart rhythm abnormalities.
Comparison of Key Discontinued Opioids
| Opioid Product | Active Ingredient | Year of Withdrawal | Reason for Discontinuation |
|---|---|---|---|
| Original OxyContin | Oxycodone HCl | 2013 | Non-abuse-deterrent formulation led to significant misuse and addiction. |
| Reformulated Opana ER | Oxymorphone HCl | 2017 | Linked to serious disease outbreak (HIV, Hep C) from injection after manipulation. |
| Fentanyl Lollipops | Fentanyl | 2024 | Misleading marketing and inappropriate off-label prescribing led to public health risk. |
| Darvon/Darvocet | Propoxyphene | 2010 | Evidence of serious heart rhythm abnormalities posing significant safety risk. |
| Jurnista | Hydromorphone | 2023 | Manufacturer decision impacted patients in Australia. |
The Impact of Discontinuations and the Role of Alternatives
The discontinuation of opioid products poses challenges for patients managing pain. Suddenly stopping or rapidly reducing opioids can lead to severe withdrawal symptoms, increased pain, and psychological distress. The FDA requires labeling changes to warn against abrupt cessation and emphasizes the need for medically supervised tapering.
Healthcare providers can consider various non-opioid alternatives for pain management. These offer effective relief with reduced risks compared to opioids. Options include:
- Non-opioid medications: Acetaminophen, NSAIDs (ibuprofen, naproxen), and certain antidepressants or anti-seizure drugs.
- Non-pharmacological therapies: Physical therapy, exercise, acupuncture, massage, meditation, and cognitive-behavioral therapy (CBT).
- Interventional pain management: Nerve blocks, radiofrequency ablation, and spinal cord stimulation for targeted relief.
Patient and provider education on alternative therapies is essential as the market changes. Resources from organizations like the CDC can help guide these transitions.
Conclusion
The landscape of prescription opioids is continuously changing. Recent and historical discontinuations, such as fentanyl lollipops, Darvon, and original OxyContin, highlight the ongoing effort to balance pain relief with patient safety and public health. Patients affected by these changes should work closely with their healthcare provider to transition to appropriate alternative pain management strategies for safe and effective outcomes. These regulatory actions reflect a continued focus on safer prescribing and a more comprehensive approach to managing pain and mitigating addiction risks.
References
- CDC: Nonopioid Therapies for Pain Management: https://www.cdc.gov/overdose-prevention/hcp/clinical-care/nonopioid-therapies-for-pain-management.html
- FDA: Harm reported from sudden discontinuation of opioid pain medicines: https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
- TGA: About the supply of oral opioid products: https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-supply-oral-opioid-products
