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The third pharmacovigilance report on Levothyrox, released on Friday, July 6, 2018 by the French Medicines Agency (ANSM), still does not explain the wave of adverse effects seen by 1.43% of patients at the new thyroid drug formula
SUMMARY OF THE LEVOTHYROX CASE . The new formula Levothyrox was claimed by the National Agency for Drug Safety (ANSM) at the German laboratory Merck in 2012 to make the product more stable over time. The change does not concern the active ingredient, levothyroxine, but on other substances excipients: lactose has been replaced by mannitol and citric acid. Nearly 31,000 patients however quickly complained of side effects. Faced with their anger, the health authorities have tried to make available other treatments, while the Levothyrox was in a quasi-monopoly situation, leading a third of them to change drugs, according to the badociation Live without thyroid. 1,200 disgruntled patients also initiated several legal proceedings for aggravated deception, involuntary injury and endangering others.
"The data badysis does not allow (…) to suggest hypotheses to the occurrence of these effects. "
Like the two previous ones, this investigation notes that the undesirable effects are identical to those already known with the old formula of this drug from Merck laboratories, but to" a totally unexpected reporting frequency " . The most common: fatigue, headache, insomnia, dizziness, joint and muscle pain and hair loss. Serious cases (deaths, hospitalizations, disabilities …) concerned 1.3% of testimonials. " The badysis of the data does not identify any patients at risk and does not suggest a hypothesis to the occurrence of these effects ", is it written in this report, which " confirms the findings " of the two previous surveys, published in October 2017 and again in January 2018.
According to the report, the adverse effects attributed to the new Levothyrox formula concern 1.43% of the approximately 2 , 2 million patients treated with this drug for the thyroid, 31,411 patients as of April 17, 2018. According to health authorities, at the end of March 2018, about half a million patients in France had abandoned Levothyrox. For the period covered by this third survey (from 1 December 2017 to 17 April 2018), 14,101 cases were reported. They are added to 5,062 cases of the first report (period from March 27 to September 15, 2017) and to 12,248 of the second report (period from September 15 to November 30, 2017). " The pharmacovigilance data, even in very large numbers, no longer make it possible to progress on this issue and formulate hypotheses ", is it indicated.
Fewer and fewer reports
" As observed in (the second survey), the peak of occurrence of effects in June-July 2017 suggests that, if patients exhibit undesirable effects under (the new Levothyrox) , these effects are manifested in majority and quickly after the change "from the old to the new formula, is it written in the report. " A very significant decrease in the number of reports began since October 2017 (…), perhaps explained by the availability of therapeutic alternatives ", is it also written. 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. The monitoring of the pharmacovigilance declarations for these products, also communicated by the ANSM, " does not bring out any particular signal of pharmacovigilance ", and only allows to note that the undesirable effects reported " are similar "to those of Levothyrox
CG with AFP
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