Opioids: the French drug agency shortens the prescription period for Tramadol


PAIN RELIEF – The Medicines Agency has decided that the prescription period for Tramadol should be no more than 3 months instead of one year, to limit misuse and the risk of dependence on this opioid. A decision that will take effect on April 15.

Tramadol can soon be prescribed only for a maximum duration of 3 months instead of a year before. The Medicines Agency (ANSM), by announcing this decision, explains that it wants to limit the risks of misuse of this drug from the opioid family. The measure will take effect on April 15, the health agency said. It remains vigilant on these products, even if in France the situation is incommensurate with the health disaster in the United States, where prescription opioids caused 17,087 deaths in 2016.

After 3 months, continued treatment with Tramadol (oral), alone or in combination with other molecules (paracetamol in Ixprim for example), will require a new prescription, says the ANSM. “To renew the prescription, the patient will have to come back to the doctor, this will reassess the pain, if he does not take too much and risks becoming addicted,” explains AFP Nathalie Richard, deputy director of analgesic drugs and narcotics. “There are still doctors and pharmacists who don’t know what an opioid is,” she said.

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Unlike other painkillers (paracetamol, aspirin, etc.), opioids, which include drugs that have the same properties as opium, can cause heavy dependence. They therefore expose to a risk of dependence, overdose and respiratory depression which can lead to death. Problems on the rise in France in recent years.

The number of hospitalizations related to the use of opioid drugs almost tripled (+ 167%) between 2000 and 2017, while the number of deaths jumped 146% between 2000 and 2015, with “at least four deaths per week” , according to an ANSM report released in February 2019. In addition, investigators from the addictovigilance network show a “growing misuse” of Tramadol.

It is thus the first opioid analgesic cited in a 2018 survey on problematic uses, both among drug users, but also in the general population for pain treatments. Dependence is observed with signs of withdrawal occurring even when taken at recommended doses and over a short period, leading to persistent taking by patients who no longer have pain.

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“Not the most powerful opioid”

Tramadol is the first analgesic involved in deaths linked to the taking of analgesics, ahead of morphine (DTA survey data 2017), and the second most frequently found on falsified prescriptions presented in pharmacies, behind codeine (OSIAP survey data 2018). It also exposes you to the risk of seizures.

“Tramadol is not the most potent opioid, but the risks of dependence are the same regardless of the opioid (including codeine),” said Nathalie Richard to the AFP. At the same time, she continues, we must continue to treat pain and there is always a favorable risk / benefit ratio for Tramadol, subject to proper use. Tramadol like codeine are weak opioids, prescription since July 2017. Morphine, oxycodone and fentanyl are strong opioids, classified as narcotics, available on secure prescriptions.

Outside of drug users, people who take weak opioids are mostly women, with a median age of 62.

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