Safety Information

Published: 6 November 2019

Monitoring

Everet (levetiracetam) - supply and potential seizure control issues for patients

 

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.

The Centre for Adverse Reaction Monitoring (CARM) has informed Medsafe that patients are having difficulties with an ongoing stock shortage of Everet (levetiracetam). Some patients, who have had to change the strength of the tablets they use, have experienced a breakthrough seizure.

There have been supply issues with certain strengths of Everet (levetiracetam) film coated tablets. Everet (levetiracetam) is available in 250 mg, 500 mg, 750 mg and 1000 mg strengths. As a result, patients have been using other strengths to make up the correct dose of their medicine. All supply issues are expected to be resolved by mid-December.

There is no pharmaceutical reason for these events as the medicine formulation is the same for all strengths (direct scale). There have been no changes to the quality or manufacture of the medicine. Levetiracetam is completely absorbed.

Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Additional information
Regulatory actions
Reporting

Advice for consumers and caregivers

If you experience any symptoms that indicate to you that your epilepsy is not being controlled talk to your doctor immediately.

Medsafe cannot give advice about an individual’s medical condition.

Information for healthcare professionals

Medsafe has been advised that there have been supply issues with Everet (levetiracetam) tablets due to manufacturing delays.

The formulation for each of the strengths is the same; the tablets are different sizes. This medicine is highly soluble and completely absorbed when given orally so there should be no difference in exposure when using different strength tablets to achieve the therapeutic dose.

Since Medsafe has been informed that some patients have nevertheless experienced difficulties, please closely monitor anyone who needs to change the tablet strengths they are taking. It may be necessary to consider a dose adjustment for some patients, particularly those with difficult to treat epilepsy.

All supply issues are expected to be resolved by mid-December.

Products affected

Product name Sponsor
Everet 250 mg, 500 mg, 750 mg, 1000 mg film coated tablets REX Medical Limited

Additional information

Advice on how to take this medicine and known side effects can be found in the consumer medicine information (CMI) and data sheet.

Search for consumer medicine information and data sheets

Regulator actions

Medsafe is continuing to monitor the rate and pattern of occurrence of this issue.

Reporting

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /