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Dr Gérald Kierzek (Medical Director)
In response to numerous alerts, the National Medicines Safety Agency asked manufacturers to limit the number of tablets per box and updated its recommendations.
It will soon no longer be possible, with some exceptions, to have a box of 30 Tramadol tablets. The decision is made for security reasons. The National Medicines Safety Agency recalled in a press release dated April 10 that more than 222 reports of overdose of this opioid, which can be very addictive, were reported to it in 2022, including around a hundred serious cases and seven deaths. Consequently, the ANSM asked manufacturers to reduce the number of tablets per box, from 30 to 10 or 15. In 2020, the ANSM had already reduced the maximum prescription duration: beyond 3 months, the Continuing treatment with Tramadol (oral) requires a new prescription.
A risk of addiction that is still too little known
Tramadol is an analgesic from the opioid family that combats pain by acting directly on its perception by the brain. Prescribed for acute pain, it has a risk of addiction and misuse that is too little perceived by the population. A survey conducted by the French Observatory for Analgesic Medicines (Ofma) published in 2022 showed that 3 out of 4 people taking Tramadol do not know the maximum daily dose (400 mg). 9 out of 10 people are also unaware that Tramadol overdose can lead to a risk of respiratory arrest. Passing a box with only 15 tablets is intended to reduce the risk.
The shortest possible treatment so as not to enter the spiral of addiction
Dr. Gérald Kierzek, emergency physician and medical director of Doctissimo, reminds us here of the principle of this prescription:
“The idea is to prescribe a level 1 analgesic (paracetamol, ibuprofen) when possible, and to use level 2 (which includes Tramadol, just below morphine) only during acute pathologies, moderate to intense. But then you need the shortest duration possible! The box of 15 tablets is made to avoid entering into a spiral of addiction, which can affect everyone, it must be remembered.
Like morphine, Tramadol is indeed the cause of increasing misuse. “People will use it for properties other than analgesia, anxiolysis (against anxiety), the euphoric, stimulating, doping side… So pay attention to the dose, the duration, the stopping which must be progressive. And pay attention to patients with a profile, with a history of addiction.”
ANSM recommendations on Tramadol
In its press release, the ANSM website also recalls the advice for proper use of the opioid:
- Respect the dose and number of doses indicated on the prescription, as well as the interval between doses and the duration of treatment;
- If the pain is not sufficiently or quickly relieved by your treatment, consult your doctor again;
- Do not stop your treatment suddenly (this may lead to withdrawal symptoms);
- Store your treatment in a closed place and not accessible to children;
- Return any tablets or capsules that you have not used to the pharmacy;
- Never offer your Tramadol treatment to anyone you know, even if they seem to have symptoms similar to yours.
If a person (child or adult) has ingested Tramadol that was not intended for them, contact a doctor immediately. poison Control Center or an emergency service: 15 (SAMU), 18 (fire brigade) or 112 (all emergencies: medical, fire, security).