Levothyrox : the new formula would not be responsible for side effects

ALLILI MOURAD/SIPA

Published the 12.10.2017 at 12: 05pm

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Lévothyroxeffets indésirablesmédicament

The drug Agency released on Wednesday the long-awaited report on the side effects associated with the new form of Levothyrox. His findings could allow more than one observer wonder. According to the MSNA, the adverse reactions reported since the arrival of the new Levothyrox are due to “an imbalance of the thyroid” caused by the change of treatment, and not to the new formula itself.

This is what emerges from the first results of the survey of pharmacovigilance, according to which ” no adverse effect of a new type, which would be specific to the single new formula has not yet been found “. “Any change of specialty or formula can alter the hormonal balance and may require a readjustment of the dosage ” which may take ” some time “, she says in a press release.

14 633 reports

On September 15, and since the format change in march, ” 14 633 calls were received by the regional centres of pharmacovigilance [CRPV] “, according to the MSNA. Among the adverse effects most commonly reported include fatigue, headache, insomnia, dizziness, joint and muscle pain, hair fall. On 5 062) the most serious cases identified by the MSNA, there are four deaths, but “the link with the Levothyrox is not established,” says the survey report.

The authors of the study wish ” that the establishment of a working group consisting of health professionals, pharmacovigilants and patients in order to continue the investigations “. The survey asks, in effect, on the case of ” there are some patients that exhibit both signs of hypo or hyperthyroidism “.

The new formula of the Levothyrox has been claimed by the MAN in the laboratory Merck in 2012 to, according to it, to make the product more stable over time. The change relates not to the active principle, but on other substances, and excipients.

New alternatives

Face the wrath of patients reporting side effects, the Health minister has announced, in mid-September, the return within fifteen days of the old formula before the arrival of alternative medicines. It has been available in pharmacies under the name Euthyrox – from 2 October, but for a length of time and in limited quantities.

After this transitional solution, the MSNA announced Wednesday that the L-Thyroxin Henning laboratory (Sanofi), which is intended to offer an alternative to patients who do not support the new Levothyrox, would be available on the 16th of October in metropolitan France and from 23 in the overseas territories.

Finally, another drug will be available from November. Until this crisis, Levothyrox was in a situation of quasi-monopoly in France, where it has been prescribed to nearly three million patients.