Products Affected - Description

• • Naltrexone oral tablet, Accord, 50 mg, bottle, 30 count, NDC 16729-0081-10
  • Naltrexone oral tablet, Accord, 50 mg, bottle, 100 count, NDC 16729-0081-01
  • Naltrexone oral tablet, Avet Pharmaceuticals, 50 mg, bottle, 30 count, NDC 23155-0886-03
  • Naltrexone oral tablet, Avet Pharmaceuticals, 50 mg, bottle, 100 count, NDC 23155-0886-01
  • Naltrexone oral tablet, Major, 50 mg, unit-dose blister pack, 30 count, NDC 00904-7036-04
  • Naltrexone oral tablet, Tagi Pharma, 50 mg, bottle, 30 count, NDC 51224-0206-30
  • Naltrexone oral tablet, Tagi Pharma, 50 mg, bottle, 100 count, NDC 51224-0206-50

Reason for the Shortage

• • Accord has naltrexone tablets on shortage due to a shortage of the active ingredient.
  • Avet has naltrexone tablets on shortage due to a shortage of the active ingredient.
  • Chartwell did not provide a reason for the shortage.
  • Mallinckrodt refuses to provide availability information.
  • Major did not provide a reason for the shortage.
  • Sun has naltrexone tablets available.
  • Tagi Pharma did not provide a reason for the shortage.

Available Products

• • Naltrexone oral tablet, Chartwell, 50 mg, bottle, 30 count, NDC 62135-0242-30
  • Naltrexone oral tablet, Chartwell, 50 mg, bottle, 60 count, NDC 62135-0242-60
  • Naltrexone oral tablet, Chartwell, 50 mg, bottle, 90 count, NDC 62135-0242-90
  • Naltrexone oral tablet, Sun Pharma, 50 mg, bottle, 30 count, NDC 47335-0326-83
  • Naltrexone oral tablet, Sun Pharma, 50 mg, bottle, 100 count, NDC 47335-0326-88

• • Accord has naltrexone 50 mg tablets on intermittent back order and the company is releasing supplies as they become available.
  • Avet has naltrexone 50 mg tablets on long-term back order and the company cannot estimate a release date.
  • Major has naltrexone 50 mg tablets in 30 count unit-dose packages on back order and the company estimates a release date of early-January 2025.
  • Tagi Pharma has naltrexone 50 mg tablets on intermittent back order and the company is releasing supplies as they become available.

• • Naltrexone is an FDA-approved medication with strong affinity to competitive mu-opioid receptor antagonist for treating opioid use disorder (OUD) and alcohol use disorder (AUD). A combination of pharmacological and psychosocial interventions for both OUD and AUD treatments is recommended in the guidelines.
  • Guideline pharmacological recommendations for OUD
  • 1. According to the 2021 VA/DoD Clinical Practice Guideline for The Management of Substance Use Disorders, the main pharmacotherapy for OUD are buprenorphine/naloxone and methadone. Intramuscular extended-release naltrexone is also suggested as an option and is in more favor compared to oral naltrexone.
  • 2. According to the 2021 SAMHSA Guideline Medications for Opioid Use Disorder for Healthcare and Addiction Professionals, Policymakers, Patients, And Families, naltrexone, methadone, and buprenorphine are the three FDA-approved medications that are indicated to treat mild-severe opioid use.
  • 3. According to the 2020 ASAM National Practice Guideline for The Treatment of Opioid Use Disorder, one of the following medications is recommended treatment in patients with OUD: naltrexone, methadone, or buprenorphine.
  • Guideline pharmacological recommendations for AUD
  • 1. According to the 2021 VA/DoD Clinical Practice Guideline for The Management of Substance Use Disorders, the recommended medications for patients with moderate-severe AUD are naltrexone and topiramate (off-label). Acamprosate and disulfiram are suggested as the next line therapy in moderate-severe alcohol use.
  • 2. According to the 2017 American Psychiatric Association Practice Guideline for The Pharmacological Treatment of Patients with Alcohol Use Disorder, naltrexone and acamprosate are recommended therapies to patients with moderate-severe alcohol use. Naltrexone is considered as first choice if patients have co-occurring OUD. Disulfiram is an alternative suggestion for AUD if patients are unable to tolerate naltrexone and acamprosate.
  • 3. According to the 2015 SAMHSA Guideline Medications for The Treatment of Alcohol Use Disorders, naltrexone is indicated for the treatment of alcohol dependence. Acamprosate is the maintenance therapy that supports abstinence in alcohol-dependent patients who are sober at treatment initiation. Lastly, disulfiram is an adjunct therapy for patients committed to enforce sobriety

• • Transitioning between medications in OUD therapy requires careful planning and supervision to avoid withdrawal symptoms.
  • Take caution with transition between opioids due to required dosing conversion.

• 1. Naltrexone. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA.
  2. 2021 VA/DoD Clinical Practice Guideline for The Management of Substance Use Disorders. https://www.healthquality.va.gov/guidelines/mh/sud/
  3. 2021 SAMHSA Guideline Medications for Opioid Use Disorder for Healthcare and Addiction Professionals, Policymakers, Patients, And Families. https://www.samhsa.gov/resource/ebp/tip-63-medications-opioid-use-disorder
  4. 2020 ASAM National Practice Guideline for The Treatment of Opioid Use Disorder. https://journals.lww.com/journaladdictionmedicine/fulltext/2020/04001/the_asam_national_practice_guideline_for_the.1.asp
  5. 2017 American Psychiatric Association Practice Guideline for The Pharmacological Treatment of Patients with Alcohol Use Disorder. https://psychiatryonline.org/doi/10.1176/appi.ajp.2017.1750101
  6. 2015 SAMHSA Guideline Medications for The Treatment of Alcohol Use Disorders. https://store.samhsa.gov/product/medication-treatment-alcohol-use-disorder-brief-guide/