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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:
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).
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. 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 20.4% and stillbirth rate of 1.0%. (See Clinical Studies). 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.
Last reviewed on RxList: 11/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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