Thousands of tablets must be returned to the pharmacy, warns the Medicines Agency.
Nearly a million and a half French people suffer from thyroid problems. Depending on the case, it is either hypothyroidism linked to a reduction or absence of thyroid hormone production or hyperthyroidism caused by an excess of thyroid hormones. The first, more common, occurs mainly in women between 35 and 60 years old. Fatigue, nervousness, depressive symptoms, hair loss, menstrual cycle disorders… are among the symptoms to bear.
The management of these disorders involves in particular drug treatments. Among these, the National Medicines Agency (ANSM) announced on January 23 the recall of several boxes of levothyroxine, produced by the Sanofi laboratory. The ANSM asks pharmacists to “contact the patients concerned by all means to inform them of this recall and allow them to exchange their box of medication for another box from a compliant batch”. Each box contains 100 tablets, so thousands of medications are affected by this recall.
The risk for patients? These medications may present an underdosage of the active ingredient – levothyroxine – and thus induce a return of symptoms linked to hypothyroidism. Patients in possession of a box affected by the recall must return it to the pharmacy. They must not stop or change their treatment without medical advice: “The probability of occurrence of an adverse effect linked to this underdosing is minimal compared to the real risk in the event of abrupt cessation of treatment” specifies the Medicines Agency. In the event of fatigue, weight gain, or chilliness after taking treatment, you should consult your doctor.
The drugs affected by the recall are:
- Lots 3R1PJ and 3R11V of L-Thyroxin Henning 50 µg, scored tablet (levothyroxine, boxes of 100 tablets);
- Lots 3R14C and 3R879 of L-Thyroxin Henning 75 mcg, scored tablet (levothyroxine, boxes of 100 tablets).
The boxes were distributed between October 2023 and June 2024. They are no longer available in pharmacies today. The other dosages (25, 63, 88, 100, 112, 125, 137, 150, 175 and 200 µg) and the other lots of L-Thyroxin Henning 50 µg and 75 µg scored tablet are not affected by the defect and therefore not covered by the recall.