New twist in the Levothyrox affair. The National Medicines Safety Agency (ANSM) publishes the first results of the pharmacovigilance survey launched around Levothyrox, a medicine for treat the thyroid, whose new formula is controversial. The first elements made public in a ANSM press release Wednesday, October 11 rule out the hypothesis of undesirable effects directly linked to the new formula of the drug, put on the market in March 2017. This thesis has been widely accepted so far, since the reporting of disabling side effects by many patients .
The first conclusions suggest that the new formula is not directly involved in the occurrence of the most frequently reported effects, namely: fatigue, headaches, insomnia, dizziness, joint and muscle pain and hair loss. Thyroid imbalances could be the cause of these symptoms according to the ANSM. “This investigation confirms the occurrence of thyroid imbalances for some patients when switching from old formula Levothyrox to new formula Levothyrox”. A finding which could be explained by “a change of specialty or formula which can modify the hormonal balance”.
The conclusions of this interim analysis are categorical: not only “all the undesirable effects testify to a thyroid imbalance in connection with the change of treatment” but in addition “no undesirable effects of a new type, which would be specific to the only new one. formula, has not been found “.
5062 serious cases recorded
These first interim analysis results will certainly not put an end to the controversy or the ongoing pharmacovigilance investigation. The health agency announces the setting up of “a working group made up of health professionals, pharmacovigilants and patients in order to continue the investigations”.
As of September 15, 2017, 14,633 reports had been received by the regional pharmacovigilance centers (CRPV) concerning adverse effects after taking the new Levothyrox. Of this total, 5,062 the most documented cases reported by patients as serious, “that is to say declared as having consequences on family, professional or social life”, have been recorded as a priority in the national database. pharmacovigilance (BNPV) according to the ANSM.
Since October 2, the old formula of Levothyroxmade his back to pharmacy for patients who really couldn’t get used to the new version, and who experience disabling side effects.
News update on #Levothyrox and other levothyroxine medicines https://t.co/b8yPPGyXhB
– ANSM (@ansm) October 11, 2017
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