For the time being, the sale of this drug, the only basis of baclofen approved for the treatment of alcoholism, has been suspended. the judiciary suspended the sale of Baclocur, o
For the time being, the sale of this drug, the only basis of baclofen approved for the treatment of alcoholism, has been suspended.
The judiciary halted sales of Baclocur, just two days after it began commercialization as the only baclofen-based drug approved for the treatment of alcoholism, it announced Thursday. The administrative court of Cergy-Pontoise agreed on Wednesday with the patient association, Baclohelp, which is considered too low in relation to the dose limits prescribed for the prescription of this drug.
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pending a decision on the merits, the judgment in the urgent procedure (abbreviated procedure) leads to a return to the previous situation: other drugs baclofen can be prescribed to alcoholics, without the legal obligation to limit the dose, he explained to the tribunal in the press release.
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“Risk of rupture treatment”
The court justified its decision by the “risk of rupture treatment” that the limitation of doses allowed with Baclocur was implemented for patients who had previously taken large amounts of baclofen. “The suspension of the judgment on the care given to them”, for its part, reacted Baclohelp, in the judgment, however, “to be very imprudent to rejoice” because “this suspension is a step before the technical” before the decision on the merits.
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The suspension is a new phase in a long dispute between baclofen supporters and health authorities who warn of its risks. This product has been used since the 1970s as a muscle relaxant, but its use has gradually shifted towards the treatment of alcoholism.
This alternative use exploded in 2008 with the publication of the book The Last Glass by cardiologist Olivier Ameisen. Since 2014, baclofen has been approved for the treatment of alcoholism thanks to a recommendation for temporary use (RTU).
“serious doubt” about marketing authorization
Then, in October 2018, Baclocur (Etypharm laboratory) was granted marketing authorization (AMM) by the Medicines Agency (MSNA), making it the only baclofen-based drug approved for alcoholism. This decision came into force on Monday with the start of commercialization of Baclocur.
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But MAN set conditions: a maximum dose of 80 mg/day and a prescription only after failure of other treatments. This prompted Baclohelp to initiate legal proceedings, after several other similar approaches, especially before the State Council.
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In its decision, the administrative court further points out “the inadequacies of the map presented by the laboratory”, which “lead to serious doubts about the legality of the marketing authorization from which he benefited”.
Date of update: June 18, 2020, 5:58 p.m
Categories: Optical Illusion
Source: newstars.edu.vn