The French Food and Drug Administration is under investigation for handling changes in thyroid drug formulations

France's drug regulator has been investigated
for publishing misleading information related to thyroid treatment drugs sold by Merck in Germany.

The story begins five years ago, when thousands of patients complained about the serious side effects
of Levothyrox's new formulation.
France has an estimated 300 Tens of thousands of people use the drug to treat hypothyroidism
.

Merck phased out earlier formulations
a few months ago.
The company explained that this formulation change was made at the request of the French National Agency for the Safety of Medicines and Health Products (ANSM) and that the new formula is bioequivalent to the original formulation
.
Merck insisted that no changes were made to the active ingredients, but did not initially publish bioequivalence results
.

In response to complaints and about 300,000 people signing a petition demanding used drugs, ANSM took the unusual step of asking Merck to put the original formula back on the market
.
ANSM, though Bioequivalence data were not initially published, but reports of side effects were subsequently analyzed
.
In 2018, ANSM insisted the drug was of "good quality.
"

But at the time, French regulators launched an investigation that searched Merck's office over concerns that the company was cheating patients who complained of memory loss, weight gain and heart palpitations
.
Meanwhile, Merck was accused in a civil lawsuit of not providing sufficient information
about the formula changes.

Earlier this year, France's Supreme Court upheld a ruling requiring Merck to pay 982 each of the more than 3,300 people with thyroid problems USD
.
Two months ago, a judge ruled that an investigation
should also be opened into the way the company provided drug information.
A lawyer for Merck at the time told Reuters that the company would cooperate with regulatory authorities, but that the investigation did not involve the new formulation
.

In a statement, ANSM insisted that it "has never denied the difficulties some patients have experienced during the transition to a new levothyroxine formulation and is working every day for the safety and well-being of their patients
.
" ANSM Every effort will be made to establish the truth, but charges against itself are strongly opposed because the institution itself has not committed a criminal offence
.
”

But a statement from a medical adviser to the French Thyroid Association said the ANSM's
responsibility was clear.
ANSM Information about the necessary adjustments to the formulation was never communicated to the public or professionals, which would have prevented many patients from suffering adverse effects
.