Safety Information

Published: 12 November 2019

Monitoring

Suspected adverse reaction reports to lamotrigine after changing brands

 

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Background
Products affected
Adverse reaction reports
Information for prescribers
Reporting
References

Background

The funding of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets changed on 1 October 2019 following a five-month transition period beginning 1 May 2019. This communication provides a summary of suspected adverse reactions reported to the Centre for Adverse Reactions Monitoring (CARM) since the transition period started. Medsafe continues to monitor these reports closely.

Products affected

The funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets is now Logem. There were three products funded previously (Arrow-Lamotrigine, Lamictal, Logem).

There are no changes to the funding of lamotrigine 2 mg and 5 mg dispersible tablets.

Lamotrigine is used for the treatment of epilepsy in adults and children from two years of age, and for the treatment of mood episodes in adults with bipolar disorder.

Adverse reaction reports

CARM has received reports from both healthcare professionals and patients. Reports received about patients who have had a change in brand include the following:

  • Changes in seizure control in patients taking lamotrigine for epilepsy. This includes patients who were previously seizure-free and experienced seizures after changing brands, and an increase in seizure frequency in those who were not seizure-free.
  • Changes in mood symptoms in patients taking lamotrigine for bipolar disorder. This includes reports of suicidal ideation or suicide attempt.
  • Other reported reactions include headache, hot flushes, memory loss, rash and tiredness.

Sadly, CARM has also received three cases reporting death as an outcome. All three cases are under Coronial investigation because the cause of death in each case is unknown. Unfortunately, each year there are a number of people with epilepsy who die and no other cause of death can be found. This is called sudden unexplained death in epilepsy (SUDEP). Each year, SUDEP affects about 1 in 1,000 adults with epilepsy and 1 in 4,500 children with epilepsy1.

Please note adverse reactions are reported to CARM based on a suspicion that the medicine could have caused the reaction. A causal link between brand changes of lamotrigine and the adverse reactions described here has not been established.

Information for prescribers

Medsafe recommends prescribers follow the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) advice that lamotrigine brand changes must be managed carefully with close patient monitoring, taking into account factors such as seizure frequency and treatment history2. The evidence that lamotrigine has a narrow therapeutic window is inconclusive at present. However, there is information to show that patients find changing brands difficult3.

PHARMAC has stated they will consider a funding application from a prescriber for a specific brand of lamotrigine for their patients with exceptional clinical difficulties who are unable change to Logem. PHARMAC has also stated they will reimburse some GP visit co-payments. More information is available on PHARMAC’s website.

Reporting

Please report any suspected adverse reactions to lamotrigine to CARM. Reports are confidential – any information that is shared with government departments to improve the safety of medicines in New Zealand is anonymised.

References

  1. Health Navigator. 2017. Epilepsy. URL: www.healthnavigator.org.nz/health-a-z/e/epilepsy/ (accessed 6 November 2019).
  2. Medicines and Healthcare products Regulatory Agency. 2017. Antiepileptic drugs: updated advice on switching between different manufacturers’ products. Drug Safety Update 11(4): 5. URL: www.gov.uk/drug-safety-update/antiepileptic-drugs-updated-advice-on-switching-between-different-manufacturers-products (accessed 22 October 2019).
  3. Epilepsy Society and Epilepsy Action. 2014. Patient experiences of switching between different versions of anti-epileptic drugs. URL: www.epilepsyresearch.org.uk/wp-content/uploads/2015/02/Patient-experiences-of-switching-between-different-versions-of-AEDs.pdf (accessed 8 November 2019).
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