New findings from the national pharmacovigilance survey on the new Levothyrox formula, initiated by the National Agency of Health Products and Medicines (ANSM), were published Tuesday, January 30, 2018. A report that completes and confirms the results from that of October 2017 .
More than 17,000 reports of adverse effects
"The continuation of the investigation (...) confirms that the adverse effects reported with the new formula Levothyrox are similar to those of the old formula Levothyrox.In fact, the overall analysis of the pharmacovigilance data does not show evidence of new effects in terms of the nature and severity of cases ", explains the ANSM.
A total of 17,310 cases reported between late March and November 30, 2017 were analyzed, representing a percentage of 0.75% of patients reporting adverse events with the new formula Levothyrox.
And to specify that "the most frequently reported adverse effects in the observations are: fatigue / asthenia, headache, insomnia, vertigo, depression, joint and muscular pains, alopecia." Adverse effects already reported according to her with the old formula of Levothyrox "with however an unprecedented and unexpected frequency."
Suspicious deaths, suicidal ideation ... No link established with the new Levothyrox formula
The agency focused particularly on the 339 cases of adverse effects selected "according to the following severity criteria: death, life-threatening, disability / disability, congenital anomalies, hospitalization." 19 cases of suspected deaths had been reported in November 2017 , but the ANSM that there is no link established with the intake of the drug.
Similarly, data on a case of suicide, which led the health authority to investigate 79 cases of suicidal ideation disorders, are not sufficiently complete "to allow for a link between adverse effects of psychiatric disorders with the new Levothyrox formula. "
An investigation far from over
"The analysis of all cases does not allow the detection of new adverse effects with the new formula Levothyrox or explanatory factors, concludes the agency.The data of this survey will continue to be analyzed pharmacovigilance complementary investigations.
Indeed, in the context of the surveillance of Levothyroxine-based specialties (former Levothyrox formula), the ANSM launched in October 2017 a pharmacoepidemiology study based on data from the Health Insurance. The results of the descriptive component are planned for the first quarter of 2018. In addition, a pharmacovigilance survey on the adverse effects of other levothyroxine-based medicinal products available since October 2017 is also in progress. An analysis of the first results is expected in the first half of 2018 so as to have sufficient data. "
As a reminder, a toll-free information number (0.800.97.16.53) is available from Monday to Friday from 9 am to 7 pm to answer patients' questions and any adverse reactions must be reported on www.signalement-sante.gouv. fr.