- The National Medicines Safety Agency (ANSM) will modify the prescription period for tramadol.
- Tramadol is indeed the opioid most implicated in deaths linked to analgesics.
- The idea is to limit the misuse of this treatment.
It is the most prescribed opioid in France. Tramadol, an opium-derived painkiller, has been the subject of vigilance by health authorities since 2014. This Wednesday, the National Medicines Safety Agency (ANSM) announces that it will modify the duration of prescription of this analgesic: it will pass, from April 15, 2020, from one year to three months.
On the other hand, what does not change is that the patient will have to buy it every month in pharmacies.
The most dangerous opioid?
"We have the opioid crisis in the United States as a backdrop," explains Nathalie Richard, deputy director of analgesic and narcotic drugs at ANSM. If France is still far from the American epidemic (70,000 deaths in 2017), the phenomenon is growing. In fact, between 2000 and 2017, the number of hospitalizations in France linked to an opioid overdose jumped by 167%, and the number of deaths between 2000 and 2015 by 146%.
As we have said, the most frequently used opioid in the country is tramadol. "Various surveillance reports have drawn our attention in recent months to a number of misuses, abuses and dependence on tramadol," explains Nathalie Richard. An addiction that can settle even for a short time and respecting the prescribed doses. These overdoses and addictions spare no one: problematic use concerns drug users, but also people affected by chronic pain. A car accident or a knee operation can therefore become a gateway to the hell of addiction. Besides this drug has a number of side effects to watch for: constipation, vomiting, headache and seizures.
Another worrying feature, this drug is the second most common analgesic found on falsified prescriptions presented in pharmacies, behind codeine. Last but not least, it is the opioid most implicated in deaths from painkillers. "A specific survey on deaths with analgesics in 2016 revealed that out of 84 deaths, 37 concerned patients who used tramadol", specifies Nathalie Richard.
Why limit the duration?
The objective is to limit misuse. "The doctor can reassess the value of the treatment for the patient every three months [and no longer once a year], insists Nathalie Richard. But also carry out a good tolerance assessment to be sure that there is no risk of abuse. Because some patients, seeing the effect of the drug fade, increase the doses alone. The interest, also, is to remind the general public that this opioid, sometimes prescribed systematically at the end of an operation, for example, is not trivial.
Caregivers need to be more educational and explain the side effects and risks. "Doctors have a role to play in identifying patients who are starting to show signs of dependence, in directing them towards structures that treat addiction," emphasizes Nathalie Richard.
Why not have withdrawn it from the market? "Tramadol maintains a favorable benefit / risk balance," she continues. Shortening the period of validity of the prescription does not limit access to this pain reliever. "There should therefore be no carry over to other analgesics."
Global monitoring
This decision, which therefore makes it possible to recall the dangers of this opioid, should above all not push patients to throw their platelets overboard. "The patient must respect the prescribed doses, do not increase the dosage alone, respect the duration of treatment, recalls Nathalie Richard. And do not stop treatment abruptly, but gradually. Because as with all opioids, the patient may experience withdrawal syndrome. Finally, if the pain is not relieved, he must go to see his doctor. "
What about other opioids? A roadmap to prevent and respond to opioid overdoses 2019-2022 was published by the Ministry of Health in July 2019. "The ANSM monitors all opioids over the water," reassures Nathalie Richard. Which specifies that for fentanyl, morphine and oxycodone, three opioids classified as narcotic, the prescription is only valid for one month. As for codeine, the agency had modified access conditions in 2017 so that all codeine medicines are dispensed only by prescription.
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