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Paris, Friday, July 27, 2018 – With the exception of
the introduction in 2015 of a modified composition in Belgium
(introduction which had been accompanied by an increase in
side effects but without causing any controversy because
including good patient preparation), France is the
first country to have "tested" the new formula of Levothyrox.
This formula consists in particular of a replacement of lactose by
another excipient, mannitol, and allows more stability
important product. France was probably chosen for
inaugurate this pbadage among others because the Levothyrox enjoyed
in our country of a quasi-monopoly, a monopoly that no longer exists
today, the crisis that led to the introduction of several
other specialties.
No reason to question the commercialization
General of the New Formula
The great difficulties that accompanied the making available of
the new formula of Levothyrox in France, suspected of being
the origin of many mis-explained side effects and that
many patients do not want to believe only related to
problems of adaptation of the dosage even to a possible nocebo effect,
could have led to questioning its dissemination in
the whole of Europe. Merck laboratories have, however, maintained
and have just received the green light from the European Atomic Energy Agency
drug (EMA). Charged by the latter to drive the "
approval process "and the" verification of
data ", the Federal Institute of Germany has indeed
deliver a positive opinion. The German experts do not have
considered that the French situation should lead to a
because of the new formula. The results of the various studies
pharmacovigilance and control have, it is true, not allowed
to highlight unexpected side effects, or
to explain by a biological cause their frequency suddenly
increased.
Helvetian patients already on the bridge
This European sesame does not mean, however, that the drug will be
soon available on all relevant national markets
(21 countries). Even though Merck reports that the "mandatory steps
required by local health authorities "have already been
validated, in some countries caution may be required in
because of the French experience. The hesitations could be
the largest in neighboring European countries, which have
participated in the supply of France in old formula.
Already the Swiss press was recently echoing mobilizations
patients to refuse the introduction of the new
formula. Nevertheless, the existence in most European countries
alternative treatments could make the choice less
Cornelius.
No shortage of public authorities
Even though the dissemination of the new formula might not
be as simple as this green light from the EMA suggests, it is
an encouraging element for Merck, whose reliability
drug is once again recognized. In the same way,
rejection yesterday by the Council of State of an application filed by
many patients who want to be maintained
perennial " the manufacture and marketing in France of
the old formula of this specialty "weakens the
criticisms of the mismanagement of the case. The
On the one hand, the judges considered that, given the
stocks available today (from the old formula) and
planned by Merck and the public authorities, nothing
seemed to justify the urgency invoked by the patients. By
elsewhere, the " Judge of the State Council Judge considers that no
characterized by a serious deficiency can not be blamed on the Minister of
solidarities of health "indicates a statement of the high
administrative jurisdiction which recalls that since the beginning of the
crisis, different actions have been implemented to respond to
patient's needs and check the composition of the drug.
Both the European authorization and this judicial decision
tend to paint a different picture of the "health scandal" that
some would like to see in the Levothyrox case.
Aurélie Haroche
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