The National Agency for the Safety of Medicines and Health Products warns against a drug based on clomiphene citrate, a treatment against female infertility that can cause vision problems.
- Treatment with clomiphene citrate stimulates ovulation. It is prescribed in first intention to treat certain sterilities, to induce ovulation during a course of PMA, or to find the cause of an absence of periods.
- 47,000 women take it each year and new safety data show that this drug can cause partial or total blindness which does not always resolve after stopping treatment.
- It is recommended to respect the prescribed dosages, to interrupt the treatment if visual disturbances appear and to consult a doctor quickly.
The 47,000 women in France who take a treatment against infertility based on clomiphene citrate and the doctors who prescribed them are called to be vigilant. This treatment, which allows, among other things, ovarian stimulation can impact vision.
Partial or total blindness adds to the potential adverse effects
In a review published on June 27, 2023the National Agency for the Safety of Medicines and Health Products (ANSM) warns: “Recent safety data from international pharmacovigilance reports and scientific publications highlight new visual adverse effects associated with treatment with clomiphene citrate, used in the event of fertility disorders in women”.
While visual changes – such as spots in the visual field, blurred vision or even phosphenes (flashing in the visual field) – are known side effects of this drug, new serious problems have been reported. “These can, in some cases, lead to partial or total blindness which does not always resolve after stopping treatment. No specific risk factors are identified, but a higher duration of use and dosage recommendations have been reported in a few cases”says the document.
Treatment should be discontinued in the event of visual disturbances.
This medicine, pointed out, is used to treat certain sterilities, to find the causes of an absence of periods or to induce ovulation during a course of a PMA. For the ANSM, it is essential that patients are informed of the visual risks associated with this treatment and that they respect the prescribed dosages.
The notice warns that the occurrence of visual disturbances during its use (previous or current treatment cycle) is a contraindication, and the use of the treatment must then be stopped. The agency also recommends that patients: “if unusual visual disturbances appear, you must immediately interrupt your treatment and consult a doctor”.
“If no other cause of visual disturbance is identified, your treatment with clomiphene should be permanently discontinued. Your doctor will order a complete ophthalmological examination and other treatment may be offered to you if necessary”, concludes the organization.
