Medicines | Epilepsy medication has run out in almost the entire country, and there are no substitute medications – “The suffering is unreasonable”

Other for example, the drug Rivatril, used for epilepsy, has an availability problem, and no substitute drugs are available, at least not yet.

The pharmaceutical safety and development center Fimea reported at the beginning of October that the German pharmaceutical company Cheplapharm Arzneimittel has reported a problem with the availability of the 0.5 and 2 milligram packaging sizes of Rivatril. According to the company, the disruption will last until the end of January.

In Finland, Rivatrile is primarily used for the treatment of epilepsy, but also, for example, for panic disorder and neurological dystonia, i.e. a disorder of brain movement regulation.

Reducing the use of the drug is not necessarily easy. Rivatril contains clonazepam, which causes addiction and withdrawal symptoms, for example. Clonazepam is a benzodiazepine, a sedative. If there is no prescription for the medicine, it is classified as a narcotic.

Rivatrile or similar benzodiazepines have been sold openly in street shops in Helsinki for years.

Eastern Finland an experienced neurologist working in the area tells HS that he has had to reduce the dose sizes of his patients and thus give instructions on stretching the adequacy of the medicines already found in the cupboard.

The doctor does not comment on the topic by name in order to guarantee the patients’ privacy.

According to the doctor, the situation is incomprehensible. The doctor says that he has had to instruct some of his patients to reduce the dose sizes much faster than normal.

“It is individual whether it results in more epileptic seizures or withdrawal symptoms. There is a big risk of that. Over the years, I have had patients who have been dosed too quickly. It has resulted in withdrawal symptoms and, in individual cases, epileptic seizures.”

The hope is that the replacement medicine will be available in pharmacies as soon as possible. It is also problematic that no drug is completely equivalent to Rivatril.

Kela does not disclose exact information on the number of users of the medicine. Since Rivatril’s drug substance is clonazepam, its substitutability can however be used to determine the number of people using prescription drugs. In 2021, 17,432 people have been compensated for clonazepam products.

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“The human suffering has been unreasonable.”

Rivatrile Someone with dystonia said on the HS opinion forum in mid-Novemberthat Fimea informed about the end of the medicine when the matter was already very acute.

“There was no time to wean off. As a result, many have stayed up all night and suffered from symptoms typical of dystonia: pain, tremors, muscle spasms and dizziness, as well as withdrawal symptoms. The human suffering has been unreasonable,” wrote the person suffering from Cervical dystonia.

Dissertation researcher Reko Ravela from the University of Helsinki evaluates HS in the opinion section Fimea’s disclosure of information as appropriate. In his writing, he emphasized the responsibility of the pharmaceutical company. Based on the EU directive, the notification of the availability problem came from the pharmaceutical company more than three months late, Ravela wrote.

For the same reason, the availability of the medicine could not be ensured in advance, says the chief physician Antero Kallio From Fime.

“If we had received the information two months before the availability disruption began, we would have had time to take proactive measures and try to ensure that there is enough medicine,” says Kallio.

Medicines that replace Rivatril include, for example, Clonazepam-containing Rivotril and Clonazepam tablets, USP. These do not have a sales license in Finland, but due to the availability problem, Fimea has issued temporary special licenses for their import and sale in October and November. Medicines are sold in different strengths. The doctor can write the medicine with a prescription in the usual way.

Medicines there are differences in prices. A pack of 100 tablets of 2 milligram doses of Rivatril costs around ten euros at the pharmacy. The corresponding price of specially licensed medicines is around 50 euros.

The drug search service of member pharmacies of Apteekkariliitto shows that Rivotrile and Clonazepam tablets, USP are not in the warehouses of pharmacies anywhere in Finland.

Medicines are imported by Tamro and Oriola.

Tamro is told by email that the order quantities received from pharmacies have been large and availability is poor.

“Due to poor availability, we have been able to bring in clearly fewer products than orders have been received. During the rest of the year, however, the product is still coming to Finland,” says the customer group manager Laura Ahonen.

Oriola could not comment on deliveries to individual pharmacies.