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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A woman in her mid-30s developed iatrogenic maniac symptoms or Hashimoto's encephalopathy-associated maniac symptoms during treatment with letrozole for infertility.
The woman started receiving treatment with letrozole 2.5 mg/day for infertility. She had a history of hypothyroidism controlled with levothyroxine sodium [levothyroxine] and had additionally been receiving aspirin, folic acid and unspecified prenatal vitamins. She reported a history of unspecified depression but denied substance use disorder, previous manic episodes or psychiatric hospitalisations. During the fourth month of letrozole therapy, her obstetrician noticed increased energy and irritability. She reported that she had been experiencing these symptoms for the past three weeks. She also reported that...
- Dlugolecki LM, et al. Manic symptoms in the context of anti-thyroid antibodies and letrozole infertility treatment. Personalized Medicine in Psychiatry 13: 19-21, Mar-Apr 2019. Available from: URL: http://doi.org/10.1016/j.pmip.2019.01.003 - USA