While some boxes of Tramadol, this opioid which can be very addictive, can contain 30 tablets, the National Medicines Safety Agency has asked manufacturers to reduce the number of tablets per box.
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Boxes of Tramadol, a pain medication, are reduced from 30 to 10 or 15 tablets, at the request of the National Medicines Safety Agency (ANSM), in order to limit the risks of dependence, according to information revealed by franceinfo on Thursday April 11.
They have arrived “since a few weeks” in pharmacies, specifies Philippe Besset, president of the Federation of Pharmaceutical Unions of France and Health Liberals on franceinfo on Thursday.
Some boxes of Tramadol could contain 30 tablets, which is often too many to treat acute pain that is expected to go away within a few days. According to the National Medicines Safety Agency, more than 222 reports were received in 2022, implicating the drug, including around a hundred serious cases and seven deaths caused by overdoses of this opioid which can be very addictive. The ANSM is therefore launching a new call for vigilance. In recent months, she has asked the 26 manufacturers who manufacture Tramadol to reduce the number of tablets per box.
“Sometimes serious side effects”
“We must treat the pain. When paracetamol, which is the reference medication, is not enough, it is important to have alternatives to provide, but nevertheless, it must be done in a minimal context and above all for as short a time as possible “justifies Philippe Besset. “There are sometimes serious side effects” with Tramadol , he specifies. Beyond serious cases, the patient may feel “dizziness” And “feel nauseous quite frequently”he explains.
Doctor Philippe Vella, medical director of the Medicines Agency, adds that having too many tablets when you don’t need them makes you run “a risk of prolonging the intake of Tramadol, or even increasing the doses” which can lead to “a situation of dependence when the pain has diminished or there is no more pain”. The new packaging, “boxes of 10 to 15 tablets or capsules allow a patient to be treated over a short period of three to four days”explains Doctor Philippe Vella.
Seven deaths in France by overdose in 2022
“We are almost tailor-made with boxes of ten”, explains Philippe Besset. Manufacturers have played the game. They have modified their manufacturing lines and are starting to deliver boxes with fewer tablets to pharmacies. “If, despite everything, there are any tablets left in the medicine cabinet, you must bring them back, we will destroy them”, urges the president of the Federation of Pharmaceutical Unions of France. The major risk being that a child swallows a Tramadol tablet. “This is the most serious risk,” he said. “Do not hesitate to contact the poison control center immediately by calling 15”specifies Philippe Besset.
Tramadol is the cause of numerous overdoses in the United States, but also now in France: seven deaths in 2022, 16 cases of convulsions and 116 seriously affected patients. “The Medicines Agency is right to make these alerts. The situation is better than in other countries in France, but we can always improve and that is the agency’s objective”concludes Philippe Besset.