No increase in "serious problems" for new formula confirmed

The new Levothyrox formula did not provoke
"serious health problems" or more hospitalizations, according to
the final report of a study of the Ministry of Health, carried out on more than two million patients and published this Thursday by the National Agency for Health and Medicine (ANSM).

The results of this pharmacoepidemiology study badyzed the number of deaths, hospitalizations and work stoppages of at least seven days, as well as the consumption of drugs between April and June 2017 – at the same time. arrival of the new formula – compared to the period from April to June 2016 for patients taking the old formula (AF).

"A clear increase" in consultations

The badysis followed the wave of unexplained adverse reaction reports that followed Merck's introduction of the new version of Levothyrox in the spring of 2017, modifying some of its excipients and providing additional stability. to the product. The study did not reveal any increase in serious health problems (deaths, hospitalizations, work stoppages …) or consumption of drugs intended to treat declared symptoms (painkillers, corticosteroids, anti-migraine, anti-vertigo, antidiarrheal … ) in connection with the transition to the new formula (NF) of Levothyrox in France.

On the other hand, it shows "a clear increase" in consultations equivalent to 360,000 additional consultations for the entire population treated in France (some three million, mostly women). At these consultations, especially GPs and endocrinologists, focused on the period from August to October 2017, is added a relative increase in the use of certain drugs such as benzodiazepines (usually taken for sleeping or anxiety) .

Alternatives to Levothyrox since 2017

In the study, the risk of death did not differ statistically between the two groups "6.355 in the NF group – new formula (0.6%) and 6.387 in the AF group – old formula (0.6%)". The additional results confirm the main results that do not favor a specific toxicity of the new formula (NF) of Levothyrox, says Dr. Rosemary Dray-Spira, epidemiologist, co-author of the report.

Additional badyzes concern the group of patients (18%) who stopped the NF at the end of 2017 to take another medicine. "At home, too, there was no more hospitalization," remarks Rosemary Dray-Spira. From October 2017, alternatives (L-Thyroxin Henning, Thyrofix, Tcap) to Levothyrox became available.