Measures for the safe use of Keppra 100mg/ml Oral Solution
Several cases of accidental overdose associated with Levetiracetam - Oral Solution have been reported throughout Europe. The majority of cases involved children between 6 months and 11 years of age. Many of these unintentional medication errors occurred due to the use of an incorrect dosing syringe. Measures are now being taken for safety reasons to ensure that only the correct dosing syringes are used in the future when assessing the dosage of Keppra Oral Solution in children. - Keppra is indicated for monotherapy of partial seizures with or without secondary generalization in adults and adolescents 16 years of age and older with newly diagnosed epilepsy. - Keppra is also indicated for the adjunctive treatment:
- partial seizures with or without secondary generalization in adults, adolescents, children, and infants 1 month of age and older with epilepsy.
- Myoclonic seizures in adults and adolescents 12 years of age and older with Juvenile Myoclonic Epilepsy.
- primary generalized tonic-clonic seizures in adults and adolescents 12 years of age and older with Idiopathic Generalized Epilepsy.
Keppra is available as an oral solution and also as film-coated tablets and an infusion solution. The preferred formulation for use in children younger than 6 years of age is the oral solution. Depending on the age of the child and the package size, a 1 ml, 3 ml or 10 ml dosing syringe is included in the package. Action at the EU level During a safety assessment, cases of accidental overdose with Keppra solution were confirmed by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Most cases involved children between 6 months and 11 years of age when the drug was administered with an incorrect dosing syringe (for example, when a 10 ml syringe was used instead of a 1 ml syringe). In these cases, 10-fold overdoses can occur. Levetiracetam overdose often has no symptoms, but it can also lead to drowsiness, restlessness, difficulty breathing, and coma. To avoid future medication errors and the risk of overdose, parents and caregivers will be reminded more forcefully in the future to always use only those dosing syringes for dosing Keppra that were provided with each package. In the future, the individual package sizes will be clearly colored differently on the carton of the packaging and will also indicate the volume of the bottle, the volume of the dosing syringe, as well as the age group of the child for which the respective package size and dosing syringe is suitable. Since there are also several generics of Keppra on the market, the recommended measures also apply to these generics.
Situation in Austria In Austria, the following medicinal products are approved under the name "Keppra": Keppra 100 mg/ml Oral Solution and: Keppra 250 mg film-coated tablets Keppra 500 mg film-coated tablets Keppra 750 mg film-coated tablets Keppra 1000 mg film-coated tablets Keppra 100 mg/ml concentrate for the preparation of a solution for infusion
and the following generic medicines containing the active substance levetiracetam in the pharmaceutical form "100 mg/ml oral solution": Levebon 100 mg/ml oral solution
Levetiracetam Accord 100 mg/ml oral solution
Levetiracetam Actavis Group 100 mg/ml Oral solution Levetiracetam G.L. 100 mg/ml Oral solution Levetiracetam Ratiopharm 100 mg/ml Oral solution Levetiracetam UCB 100 mg/ml Oral solution The BASG has not received any adverse event reports from Austria from the period in question.
BASG recommendations Recommend ations for healthcare professionals:
- Physicians should ensure that the correct age-appropriate dosage form and package size of Keppra is prescribed.
- Pharmacists should ensure that the appropriate pack size of Keppra is dispensed.
- Parents or caregivers should be counseled on how to properly measure the prescribed dose when filling the prescription.
- To avoid medication errors and the risk of overdose, parents or caregivers should be reminded to always use only the dosing syringe that is included with the medication. Once the bottle is empty, the syringe should also be discarded to avoid confusion later.
Recommendations for patients:
- Parents or caregivers should verify that they are using the correct dosing syringe when measuring the dose.
- Only the dosing tip that is included with the medication should be used.
- Once the bottle is empty, the syringe should be discarded (and not kept) to avoid confusion later.
- The Instructions for Use contain clear instructions to minimize the risk of incorrect dosing.
- However, if there is any uncertainty or concern about the proper use of the drug, a doctor or pharmacist should be consulted immediately.
Additional information: Decision of Measures for the Safe Use of Keppra 100mg/ml Oral Solution dated Oct. 14, 2016: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002622.jsp&mid=WC0b01ac058004d5c1
Queries (technical): Dr. Christoph Baumgärtel, Tel: 050555/36004 Email: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel: 050555/25000 Email: presse@ages.at
