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Dr Gérald Kierzek (Medical Director of Doctissimo)
Medical validation:
October 31, 2023
According to an alert from the Medicines Agency, certain boxes of Levothyrox present a quality defect. What are the risks ? And how to react if you are concerned? Dr. Kierzek, medical director of Doctissimo, answers us.
Once again, Levothyrox is making headlines. According to the latest bulletin from the National Medicines Safety Agency (ANSM), a batch of Levothyrox 25 µg would present a “very small excess of 0.4% of the maximum acceptable limit for active ingredient“. Update on this announcement.
All boxes from batch G01U7X are recalled
While the new formula of Levothyrox has given rise to several legal proceedings, a batch of this drug is now recalled.
“We have been informed by the Merck laboratory of a very small exceedance of 0.4% of the maximum acceptable limit of active ingredient for batch G01U7X of Levothyrox 25 µg (scored tablet, boxes of 90 tablets)“, indicates the ANSM in its press release.
The Agency nevertheless specifies that the other dosages (50, 75, 88, 100, 112, 125, 137, 150, 175 and 200 µg) and the other batches of Levothyrox 25 µg are not affected by this quality defect, which occurred during of the “manufacturing of medicine“.
However, even if the risk of side effects linked to this small overdose is “very minimal“, pharmacists are invited to “contact the patients concerned so that they are informed of this recall and that their boxes are replaced by another compliant one“.
For information, the targeted batch of Levothyrox 25 µg was distributed in pharmacies from mid-July.
What is the right course of action to take?
First, it is recommended to check your batch number.
If a reference other than “G01U7X” is written on your box, you are not affected by this recall.
Then, you should definitely not stop or change your treatment without medical advice.
“The probability of occurrence of an adverse effect linked to this small overdose is very minimal compared to the real risk in the event of abrupt cessation of treatment.“, warns the ANSM.
A warning, which Dr Kierzek validates.
“Patients are at greater risk of stopping this medication than of continuing it. + 0.4% active substance, that’s nothing. Conversely, stopping the medication can have serious repercussions. You should therefore not stop this treatment spontaneously.“, he assures.
As for people who own the recalled batch, the Agency invites them to return their box to the pharmacy, where the pharmacist will exchange it with a new compliant box.
If you experience symptoms suggestive of hyperthyroidism, such as palpitations, excessive sweating, a feeling of heat, hand tremors, mood or sleep disorders, etc., it is recommended to consult your doctor (if necessary, he will carry out a check of your TSH) and also make a declaration on the reporting portal.