MHRA Drug Safety Update May 2017
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (vol 10, issue 10, May 2017) has been published and includes articles on:
- Finasteride: rare reports of depression and suicidal thoughts;
- New e-learning modules on reporting suspected adverse drug reactions; and
- Letters sent to healthcare professionals in April 2017, including reminder of retigabine (Trobalt) withdrawal.
In September 2016, an important communication was sent to professionals who specialise in the treatment of epilepsy to inform them of the withdrawal of retigabine (Trobalt®) from the market in June 2017. This product is being discontinued because of limited and declining use.
The letter outlines advice for healthcare providers to begin seeking alternative treatment for affected patients, and to withdraw treatment with a gradual dose reduction over at least 3 weeks. No new patients should start retigabine treatment.
Retigabine (Trobalt®) is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
Practices are advised to search for patients who are currently receiving prescriptions for retigabine and plan their alternative treatment, consulting with secondary care clinicians as appropriate.
Drug Safety Update volume 10 issue 3, October 2016: 2.