Imported from Germany, old formula of this drug for thyroid is available since Monday under name of Euthyrox. Manufactured by Merck laboratory, such as Levothyrox, Euthyrox will be available "for a limited time and limited quantities [130,000 boxes of 100 tablets in 8 different dosages]" for 22,000 French pharmacies, National Security of Medicines and Health Products (ANSM).
According to Agency, doctors should refore only prescribe Euthyrox as a "last resort", to patients who complain of side effects (cramps, headaches, dizziness, hair loss) related to new Levothyrox. But, says Dominique Martin, Director General of ANSM, "we have recoveries that show that this is not necessarily what happens".
Read also: Levothyrox controversy explained in six points"Postpone problem"
On Monday morning, ANSM sent an information document to health professionals. This document says that prescriptions must imperatively mention name "Euthyrox" and be post-September 14 to make it possible to deliver this drug.
Health authorities estimate more than 9,000 adverse reaction reports for new Levothyrox formula marketed since March.
In total, three million patients take Levothyrox in France ( world's largest market) to treat hypothyroidism or after an operation of thyroid cancer.
Chantal L'Hoir, President of French Association of Thyroid Patients (AFMT), said that "pharmacists do not have enough boxes." It also criticizes " temporary nature of this release to old formula". A petition launched this summer claims 294,500 signatures. Several legal proceedings are also underway.
According to Alain Delgutte of Ordre des pharmacistes, temporary provision of Euthyrox is tantamount to "delaying problem", since "sooner or later, this formula will be suppressed".
Read also: Levothyrox: crisis forces authorities to moveSeveral alternative medicines
Merck intends to generalize use of new formula. France was first country to introduce it, but laboratory said in early September that certification procedures were underway elsewhere.
The new formula of Levothyrox was claimed by ANSM at laboratory in 2012 in order to make product more stable. The change of formula does not concern active principle but on or substances, excipients.
Faced with anger of patients reporting side effects, Minister of Health, Agnès Buzyn, had announced on 15 September return in pharmacy within fifteen days of old formula of Levothyrox and alternative medicines under a month.
According to ANSM, anor drug, L-Thyroxin Henning (Sanofi laboratory), will be available from mid-October. A drug in form of drops, L-Thyroxine (Laboratory Serb), also exists, but it is prescribed as a priority for children and people who have swallowing disorders.
Finally, Managing Director of ANSM announced on Monday that arrival of anor equivalent drug was studied for November: "It is a drug used in a European country, which does not have same excipients" as new formula of Levothyrox.