Lamotrigine is an anticonvulsant medicine been in the market for more than 25 years with the brand name Lamictal and also available in generics. It is used in the treatment of epileptic seizures and also as maintenance treatment for delaying the occurrence of mood episodes such as depression, mania, or hypomania in patients with the mental health condition – bipolar disorder.

USFDA released a drug safety communication for the potential increased risk of abnormal heart rhythms in patients (having concurrent heart related problems) treated with lamotrigine.

Risk of heart rhythm problems:

Review of safety data by United States Food & Drug Administration (USFDA) has identified an increased risk for heart problems like – irregular heartbeats (arrhythmias) in patients with underlying medical conditions pertaining to heart disease. Evidence from relevant case reports of lamotrigine at USFDA revealed abnormal electrocardiographic (ECG) findings, chest pain, loss of consciousness, and cardiac arrest.

USFDA requested marketing authorization holders to perform in vitro studies for further investigation of this safety concern. However, this safety information is being updated in the prescribing information and patient leaflet documents of lamotrigine.

Important information for Consumers:

Do not discontinue this medicine owing to this potential risk of heart rhythms. Consult your respective health care professional before taking any decision, since they would analyze the benefit-risk profile based on your current medications or medical conditions for safe medicine use.

Inform your doctor if you have any prior history or ongoing medical conditions related to heart for optimizing the safe use of lamotrigine.

Immediately report or consult your healthcare professional if your experience the below symptoms (related to abnormal heart rhythms).

  • Racing heartbeat
  • Skipped or slow heartbeat
  • Shortness of breath
  • Dizziness
  • Fainting

Important information for Health care professionals:

  • Bring awareness to patients or patient care providers or consumers on the potential risk of this medicine.
  • Assess individual benefit-risk analysis based on the patient’s concomitant medication use, concurrent medical conditions especially related heart problems.
  • Consider recommending this medicine ONLY if the anticipated benefits outweighs the potential risks of this medicine in particular patient.
  • Educate patients or patient care providers or consumers of this medicine to report any suspicious adverse effects which could be symptoms of arrhythmia condition (mentioned above).

Voluntary ADR reporting

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby promotes patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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