Ortho Tri-Cyclen (ethinyl estradiol and norgestimate) is an oral prescription contraceptive medication indicated for the prevention of pregnancy and the treatment of acne. This medication mimics naturally occurring hormones within the female body and acts by preventing egg release from the ovaries. The U.S. Food and Drug Administration (FDA) has issued a number of drug warnings for Ortho Tri-Cyclen, which should be discussed with your gynecologist before you begin treatment with this medication.
Thromboembolic Disorders
Use of Ortho Tri-Cyclen is associated with an increased risk of thromboembolic disorders. Such disorders can include heart attack (myocardial infarction) or development of a blood clot within the legs (deep vein thrombosis), lungs (pulmonary embolism) or brain (stroke). The risk of developing a thromboembolic disorder is highest among women over the age of 35 who smoke while taking Ortho Tri-Cyclen. In one study cited by the FDA, the risk of hemorrhagic stroke -- a condition characterized by bleeding within the brain -- was 7.6 in women who used oral contraceptives and smoked cigarettes. In contrast, this risk was 1.2 for women who used oral contraceptives and did not smoke cigarettes.
Breast and Reproductive Organ Cancer
The FDA reports that women who use oral contraceptives such as Ortho Tri-Cyclen are at an increased risk of developing breast, cervical, uterine and ovarian cancer. This risk progressively declines once treatment with Ortho Tri-Cyclen ends.
Hepatic Neoplasia
Women who use Ortho Tri-Cyclen or other types of oral contraceptives are at an increased risk of developing non-cancerous (benign) liver tumors (hepatic neoplasia). Approximately 3.3 cases of hepatic neoplasia are reported in every 100,000 women who use oral contraceptives, based upon estimates provided by the FDA. This risk appears to increase in women who use oral contraceptives continuously for four or more years.
Ocular Lesions
Eye lesions of the retina have been reported in women who use Ortho Tri-Cyclen. The FDA warns that you should stop using oral contraceptives if you experience loss of vision, eye displacement due to swelling (proptosis) or optic nerve damage (papilledema).
Gallbladder Disease
If you use Ortho Tri-Cyclen, you may be at an increased risk of developing gallbladder disease. Symptoms of gallbladder disease include abdominal pain or bloating, indigestion, nausea and vomiting.
Increased Blood Pressure
Women who take this type of oral contraceptive are at a significantly elevated risk of developing an increase in blood pressure. This risk is higher among older women and tends to increase with prolonged use of this medication. After stopping treatment with Ortho Tri-Cyclen, your blood pressure should return to a normal level. If you have significantly high blood pressure (hypertension), you should not use Ortho Tri-Cyclen.
Irregular Bleeding
While taking Ortho Tri-Cyclen, you can develop abnormal or irregular vaginal bleeding, especially during the first three months of treatment, warns the FDA. If this occurs, speak with your gynecologist to ensure that you are not pregnant and do not have a vaginal infection or disease.
