Naldemedine-induced Opioid Withdrawal Syndrome in a Patient with Breast Cancer without Brain Metastasis

Ishii, Koji; Yamashita, Haruna; Yamaguchi, Midori; Komatsu, Yuya; Ryu, Emi; Morishita, Satoru; Matsuo, Kumi; Kamada, Masatsugu; Ikeda, Tsunako; Ashizawa, Kazuto; Hara, Tetsuya

doi:10.2169/internalmedicine.3098-19

Cited by 8 publications

(6 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Naldemedine is a PAMORA, and the mechanism of action suggests that efficacy may be greater for a shorter duration of opioid exposure. Administration of naldemedine from the initiation of opioids may also reduce the risk of developing the opioid-withdrawal symptoms that can be seen when naldemedine is started during opioid administration [22,23]. On the other hand, the factor "naldemedine prescription within 2 days of opioid initiation" was not extracted as a significant factor in the present study.…”

Section: Plos Onementioning

confidence: 59%

Factors associated with non-response to naldemedine for opioid-induced constipation in cancer patients: A subgroup analysis

et al. 2022

View full text Add to dashboard Cite

Background Opioid-induced constipation (OIC) is one of the most common adverse events of opioid therapy and can severely reduce quality of life (QOL). Naldemedine is the orally available peripheral-acting μ-opioid receptor antagonist approved for OIC treatment. However in daily clinical practice, some cancer patients show insufficient control of OIC even while receiving naldemedine. Objective To identify factors associated with non-response to naldemedine in cancer patients. Methods This study retrospectively analyzed 127 cancer patients prescribed naldemedine at Seirei Hamamatsu General Hospital in Japan between November 2016 and June 2021. For the regression analysis of factors associated with OIC, variables were extracted manually from electronic medical records. Naldemedine had been prescribed by the attending physician after the presence of OIC had been defined with reference to Rome IV diagnostic criteria. Naldemedine was evaluated as “effective” in cases where the number of defecations increased at least once in the first 3 days after starting naldemedine. Multivariate logistic regression analysis was performed to identify factors associated with non-response to naldemedine. The data used were from the group of patients who received naldemedine in our previous study. Results Factors significantly associated with non-response to naldemedine included chemotherapy with taxanes within 1 month of evaluation of naldemedine effect (odds ratio [OR] = 0.063; 95% confidence interval [CI] = 0.007–0.568), and addition of or switching to naldemedine due to insufficient efficacy of prior laxatives (OR = 0.352, 95% CI = 0.129–0.966). Conclusion The identification of factors associated with non-response to naldemedine prescribed for OIC may help improve QOL among cancer patients.

show abstract

Section: Plos Onementioning

confidence: 59%

Factors associated with non-response to naldemedine for opioid-induced constipation in cancer patients: A subgroup analysis

et al. 2022

View full text Add to dashboard Cite

show abstract

“…To the best of our knowledge, there is only one report of opioid withdrawal syndrome due to naldemedine administration (Ishii et al, 2020), and although moderate physical symptoms occur 1 h after administration, it is not accompanied by severe psychiatric symptoms such as those observed in this case. It should be kept in mind that, as in this case, there may be some cases which mainly present with severe psychiatric symptoms.…”

Section: Discussionmentioning

confidence: 54%

Naldemedine-induced opioid withdrawal syndrome with severe psychiatric symptoms in an advanced cervical cancer patient without brain metastasis

et al. 2021

View full text Add to dashboard Cite

Objective Naldemedine, an oral peripheral μ-opioid receptor antagonist, was developed for the treatment of constipation, a side effect of opioid use. Naldemedine is not generally recognized as causing opioid withdrawal in which associated symptoms affecting the central nervous system. Method From the series of cancer patients undergoing symptom management, we report a case treated with naldemedine for constipation in relation to the use of opioids for cancer pain and who displayed severe psychological symptoms associated with withdrawal immediately after the use of naldemedine. Results The patient was a 36-year-old woman diagnosed with cervical cancer Stage IIB, PS3. When the patient, who was using oxycodone hydrochloride hydrate (80 mg/day) for ileal pain, was started on naldemedine for constipation, she complained of sweating after just 5 min and hallucinations after 1 h. The patient also displayed physical/behavioral abnormalities such as diarrhea and hyperactivity, and psychological abnormalities such as aggression toward staff. Despite the psychiatric symptoms worsening over time, there were no abnormalities in terms of blood biochemical data, and no brain metastasis was observed on MRI. Based on the Clinical Opiate Withdrawal Scale, these symptoms were judged to indicate opioid withdrawal. Naldemedine was discontinued due to naldemedine-related opioid withdrawal syndrome and, thereafter, the psychiatric symptoms diminished, with no recurrence of similar symptoms observed to date. Significance of results If mental and behavioral abnormalities occur in patients receiving naldemedine, it is necessary to consider the possibility of opioid withdrawal syndrome as a differential diagnosis.

show abstract

“…A feature of this case was the appearance of withdrawal syndrome 4 months after the start of naldemedine administration. The cases of naldemedine-induced withdrawal syndrome reported to date differed significantly in that the onset of symptoms was observed within 1 h after administration (Ishii et al, 2020; Ishida et al, 2021). The cause of the appearance of OWS at 4 months after administration of naldemedine is unknown, and future research is required to clarify this.…”

Section: Discussionmentioning

confidence: 99%

“…She had been receiving naldemedine for 4 months and anxiety and sweating were prominent. OWS was suspected based on previous reports of OWS due to naldemedine (Ishii et al, 2020; Ishida et al, 2021) and it was decided to discontinue naldemedine treatment and follow-up.…”

Section: Case Reportmentioning

confidence: 99%

See 1 more Smart Citation

Opioid withdrawal syndrome developing after long-term administration of naldemedine

Ishida

Uchida²,

Yabuno

et al. 2022

Pall Supp Care

View full text Add to dashboard Cite

Objective One of the side effects of opioid administration is opioid-induced constipation (OIC). To address this side effect, the oral peripheral μ opioid receptor antagonist naldemedine was developed. As this drug does not cross the blood–brain barrier, it is thought that it does not lead to opioid withdrawal syndrome (OWS) with central nervous system symptoms. Methods Here, we report a cancer patient who presented with symptoms centered round anxiety and irritation 4 months after administration of naldemedine for OIC and who was diagnosed with OWS after close investigation. Results The patient was a 65-year-old female who had surgery for stage IB endometrial cancer 4 years previously, but experienced recurrence involving the pelvis 2 years later. Medical narcotics were used to control pain, but naldemedine was started to control subsequent constipation. When naldemedine-related OWS was suspected and the administration of naldemedine discontinued, the above symptoms disappeared within two days, and no recurrence was observed thereafter. Significance of the results For patients receiving naldemedine, it is necessary to consider the possibility of OWS regardless of the period of administration in order to maintain patient quality of life.

show abstract

Naldemedine-induced Opioid Withdrawal Syndrome in a Patient with Breast Cancer without Brain Metastasis

Cited by 8 publications

References 9 publications

Factors associated with non-response to naldemedine for opioid-induced constipation in cancer patients: A subgroup analysis

Factors associated with non-response to naldemedine for opioid-induced constipation in cancer patients: A subgroup analysis

Naldemedine-induced opioid withdrawal syndrome with severe psychiatric symptoms in an advanced cervical cancer patient without brain metastasis

Opioid withdrawal syndrome developing after long-term administration of naldemedine

Contact Info

Product

Resources

About