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The third pharmacovigilance report on Levothyrox, released Friday by the Agence du médicament, still does not explain the wave of adverse reactions attributed by some patients to the new formula of this drug for the thyroid.
This announcement comes after the National Agency for the Safety of Medicines (ANSM) confirmed "the good quality of the new formula" Levothyrox.
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"The badysis of the data does not make it possible to identify any patients at risk and does not make it possible to propose a hypothesis at the occurrence of these effects", is it written in the report of the Medicines Agency, which "confirms the findings" of the two previous surveys, published in October and again in January.
"The pharmacovigilance data, even in very large numbers, no longer make it possible to progress on this issue and formulate hypotheses," it says.
The number of reports decreasing since last October
According to this pharmacovigilance report submitted to the Agence du médicament, the number of reports of adverse effects attributed to the new Levothyrox formula is 31 411 at the date of April 17. That is 1.43% of the estimated 2.2 million patients treated with this thyroid medication.
For the period covered by this third survey (from 1 December 2017 to 17 April 2018), 14,101 cases were reported (91.3% women). They are added to the 5062 cases of the first report (period from March 27 to September 15, 2017) and 12 248 of the second report (period from September 15 to November 30, 2017).
Like the two previous ones, this investigation notes that the adverse effects are identical to those already known with the old formula of this drug Merck laboratories, but in much greater numbers. The most common: fatigue, headache, insomnia, dizziness, joint and muscle pain and hair loss. "A very significant decrease in the number of reports began since October 2017 (…), perhaps explained by the availability of therapeutic alternatives," it is written.
1200 complaints against Merck
Before the change of formula in spring 2017, Levothyrox was in a quasi-monopoly situation in France. But because of the crisis that followed, four competitors to its new formula are now available: L-thyroxin Henning, Thyrofix, L-thyroxine SERB, and TCAPS.
According to health authorities, at the end of March 2018, about half a million patients in France had abandoned this drug.
About 1,200 disgruntled patients complained against Merck
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