The conditions for prescribing and dispensing topiramate, a drug prescribed alone or in combination to treat epilepsy and prevent the onset of migraines, were updated on May 2, 2023.
[Mis à jour le 3 mai 2023 à 10h07] Prescribing conditions for topiramate, a second-generation antiepileptic drug, have been modified May 2, 2023by theMedicines Agency (ANSM)for girls, adolescents, women of childbearing age and pregnant women, in order to limit exposure during pregnancybecause of risks of neurodevelopmental disorders for the unborn child. From now on, the prescription of topiramate (Epitomax and generics) must be carried out annually by a neurologist or pediatrician. Renewal is possible by any doctor in the meantime. The patient and the neurologist or the pediatrician must sign a care agreement every year, establishing that the patient has been informed of the risks of the treatment for her unborn child in the event of pregnancy. Furthermore, dispensing in pharmacies can only be done on presentation: of a prescription drawn up by a neurologist or a pediatrician dating back less than a year or of the care agreement signed by the patient (or by her legal representative ), as well as by the neurologist or pediatrician.
What are the new conditions for dispensing Topiramate in 2023?
The ANSM has modified the conditions for prescribing and dispensing drugs containing topiramate for girls, adolescents, women of childbearing age and pregnant women on November 2, 2022 for topiramate treatment initiations and May 2, 2023: for patients undergoing topiramate treatment:
Beginning of treatment
- Since November 2, 2022, a topiramate drug can only be prescribed the first time by a neurologist or pediatrician;
- During this first prescription, the patient must sign with her medical specialist care consent form who certifies in particular that she has been informed of the risks for the unborn child in the event of exposure during pregnancy and of the need for effective contraception. For minor patients, this care agreement is signed by the parents.
Since May 2, 2023, the patient must consult her neurologist or the child’s pediatrician, at least once a year to reassess the need to continue treatment or not., particularly with regard to a pregnancy project. During this consultation, she must again sign the annual care agreement form. In the meantime, the general practitioner can renew the prescription.
Delivery of treatment in pharmacy
To obtain the medicine or that of the child, the patient must present the annual prescription from the neurologist or the pediatrician, as well as the annual co-signed care agreement form for the initiation of treatment or for the continuation of treatment.
It is important to fully understand the risks associated with exposure to these drugs during pregnancy and the associated precautions. Do not hesitate to ask health professionals:
- An effective method of contraception should be used throughout the treatment;
- In the event of a pregnancy project, you should not stop your contraception before having been able to discuss with the doctor who must adapt the care to the pregnancy project.
- In the event of pregnancy, treatment should not be stopped without having discussed with the doctor.
Definition: what is topiramate?
Topiramate is a second-generation antiepileptic drug. It is a monosaccharide (simple sugar) marketed in the form of tablets or capsules depending on the dosage.
Indications: when to take topiramate?
Topiramate is primarily used in the treatment of partial epilepsy, generalized seizures or seizures associated with Lennox-Gastaut syndrome (rare brain condition). It is administered alone in adults and children over 6 years of age, or in combination with another antiepileptic from the age of 2 years. In addition, topiramate can also be used in adults at preventive aim as basic treatment of migraine. The administration is daily and not punctual in order to reduce the number of migraine attacks. The duration of treatment, of the order of several months, is variable depending on the patient.
How does topiramate work?
Its mode of action remains unknown. However, certain studies have made it possible to put forward hypotheses relating to the mechanisms of action involved. Topiramate would notably induce a increased gamma-aminobutyric acid (GABA) activity): substance naturally produced by neurons.
Trade names: what medicines contain topiramate?
The commercial specialty Epitomax® contains topiramate in dosages of 15 mg, 25 mg, 50 mg, 100 mg and 200 mg, just like the generics available:
- Topiramate Accord
- Topiramate BGR
- Topiramate Mylan
- Topiramate Sandoz
What are the side effects of topiramate?
The side effects of topiramate are numerous. The most common are diarrhoea, nausea, nasopharyngitis, depression, fatigue, dizziness or even a feeling of drowsiness. Other effects like a loss of appetite, impaired language, attention and memory can be observed.
What are the risks of Topiramate if taken while pregnant?
Children exposed to topiramate during pregnancy are at risk of:
- Major malformations: cleft lips and palate (cleft lip and palate), damage to the genitals (hypospadias) and reduction in the size of the head and brain (microcephaly). According to the latest studies, the observed risk of major malformations is up to 8.2%.
- Risk increased by low birth weight newborn;
- Risk of neurodevelopmental disorders: a risk of developing autism spectrum disorders which is between 2 and 6%; a risk of occurrence of intellectual disability which is between 1 and 8%.
Does topiramate make you lose weight and why?
The reason why topiramate causes weight loss has not been identified with certainty. Firstly, the possible loss of appetite caused by taking topiramate would lead to weight loss. On the other hand, animal studies have shown that topiramate block lipogenesis (production of fat in the body). In France, this medicine is not indicated for weight loss. A prescription with such an objective would lead to a diversion of its use. Due to the potential risks, it is available only by prescription and should not be taken for any indication other than epilepsy and migraines.
What are the contraindications of topiramate?
In pregnant women or women of childbearing age and who do not have an effective method of contraception, topiramate is contraindicated in the treatment of migraine And contraindicated in the treatment of epilepsy except in cases of absolute necessity (ineffectiveness of other treatments or intolerance to other treatments). Before starting treatment, patients should be informed of the significant risk of malformation in the event of pregnancy. A pregnancy test should be performed in women of childbearing age to exclude the risk and effective contraception should be administered throughout the treatment. The choice of contraceptive is made in consultation with the doctor because topiramate can reduce the effectiveness of some pills. Additionally, the drug should not be taken in case of known allergy to any of the components.
– Public drug database
– Treatise on obesity medicine and surgery: Drug treatments for obesity, 454. Editions Lavoisier, 2011.