Pharmacovigilance in hospice/palliative care: rapid report of net clinical effect of metoclopramide

J Palliat Med. 2012 Oct;15(10):1071-5. doi: 10.1089/jpm.2012.0111. Epub 2012 Jul 30.


Background: Understanding the performance of prescribed medications in day-to-day practice is important to minimize harm, maximize clinical benefits, and, eventually, better target the people who are most likely to benefit, especially in hospice/palliative care where there may be limited time to optimize prescribing. Metoclopramide, a benzamide prokinetic antiemetic, is widely used for a number of indications including nausea, vomiting, hiccups, and reflux. It has recently had a new "black box" warning issued by the Food and Drug Administration in relation to tardive dyskinesia to limit use to 12 weeks.

Methods: A consecutive cohort of patients from 12 participating centers in two countries who were having metoclopramide initiated had data collected at three time points--baseline, 2 days (clinical benefit), and day 7 (clinical harm). Additionally, harms could be recorded at any time.

Results: Of the 53 people included in the cohort, 23 (43%) reported benefit at 48 hours, but only 18 (34%) of these people were still using it one week after commencing it. For the other 5, the medication was ceased due to harms. The most frequent harms were akathisia (n=4), headache (n=4), and abdominal pain (n=4). Nine people (17%) had no clinical benefit and experienced harms.

Conclusion: Overall, one in three people gained net clinical benefit at one week. Limiting effects include side-effects that need to be sought actively in clinical care.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antiemetics / adverse effects*
  • Antiemetics / pharmacokinetics
  • Cohort Studies
  • Female
  • Hospices*
  • Humans
  • Male
  • Metoclopramide / adverse effects*
  • Metoclopramide / pharmacokinetics
  • Middle Aged
  • Palliative Care*
  • Pharmacovigilance*
  • Young Adult


  • Antiemetics
  • Metoclopramide