---

Drugs: Pyridostigmine Bromide

Answer

In the community, pyridostigmine bromide is licensed for the treatment of myasthenia gravis, paralytic ileus and post-operative urinary retention. Based on this information, it would be expected that patients with any of these three medical conditions could receive the drug. The recognised side-effects of a medicine are documented in its product information. This consists of a summary of product characteristics (SPC) for healthcare professionals and a patient information leaflet (PIL) which accompanies the medicine. The SPC and PIL for pyridostigmine are available to view online at: www.medicines.org.uk. Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the yellow card scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines. As of 6 September 2011, the MHRA has received a total of 29 UK spontaneous suspected ADR reports associated with pyridostigmine. These reports describe a total of 77 reactions, two of which had a fatal outcome. A complete listing of all UK spontaneous suspected ADR reports associated with pyridostigmine is available to view on our website at: www.mhra.gov.uk/daps. It should be noted that healthcare professionals and patients are asked to report suspected adverse reactions on a voluntary basis and the submission of a report does not mean that the reaction cited was definitely caused by the medicine. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the underlying disease being treated.

Secondary information

Type

Written question

Reference

11577; 730 c40-1WA

Session

2010-12

Subjects

Side effects Pyridostigmine bromide

Link

View this Written question on www.publications.parliament.uk