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A causal relationship between ovarian hyperstimulation and ovarian cancer has not been determined. However, because a correlation between ovarian cancer and nulliparity, infertility, and age has been suggested, if ovarian cysts do not regress spontaneously, a thorough evaluation should be performed to rule out the presence of ovarian neoplasia. Careful attention should be given to the selection of candidates for Clomid therapy. Pelvic examination is necessary prior to Clomid treatment and before each subsequent course (see CONTRAINDICATIONS and WARNINGS). The purpose and risks of Clomid therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of Clomid therapy is ovulation for subsequent pregnancy. The physician should counsel the patient with special regard to the following potential risks: Visual Symptoms. Advise that blurring or other visual symptoms occasionally may occur during or shortly after Clomid therapy. It should be made clear to the patient that, in some instances, visual disturbances may be prolonged, and possibly irreversible, especially with increased dosage or duration of therapy. Warn that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting (see WARNINGS). The patient should be instructed to inform the physician whenever any unusual visual symptoms occur. If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation performed. Abdominal/Pelvic Pain or Distention. Ovarian enlargement may occur during or shortly after therapy with Clomid. To minimize the risks associated with ovarian enlargement, the patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort, or distention after taking Clomid (see WARNINGS). Cases of hypertriglyceridemia have been reported. Preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment with Clomid are associated with a risk of hypertriglyceridemia. Periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia (see ADVERSE REACTIONS). Please refer to the DOSAGE AND ADMINISTRATION section for recommended dosage and treatment duration. Inform the patient that there is an increased chance of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy, when conception occurs in relation to Clomid therapy, nolvadex 10 mg antiestrogens nolvadex. The potential complications and hazards of multiple pregnancy should be explained. Spontaneous Abortion and Congenital Anomalies. Inform the patient that the available data suggest no increase in the rates of spontaneous abortion (miscarriage) or congenital anomalies with maternal Clomid use compared to rates in the general population. During clinical investigation, the experience from patients with known pregnancy outcome (Table 1) shows a spontaneous abortion rate of 20. Among the birth anomalies spontaneously reported as individual cases since commercial availability of Clomid, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by Clomid, but this has not been supported by data from population-based studies.
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