Side Effects
- Side effects are typical of most oral contraceptives and can include breast tenderness, headache, nausea, breakthrough bleeding, ankle swelling and weight gain. These side effects are typically mild and tend to resolve by the second or third cycle of therapy.
- Rare side effects include venous thromboembolism and hypertension and occur at a same incidence rate as standard oral contraceptives.
Risks
- Diane-35 has many properties in common with estrogen/progestogen combination oral contraceptives and the same contraindications warnings and precautions applicable to this class of drugs should be considered. Other Esrtogen and/or progestogen should not be taken during treatment with Diane-35.
- The risk of pulmonary embolism (PE) is slightly increased among users of oral contraceptives including Diane-35.
- The increased risk of venous thromboembolism (deep venous thrombosis or VTE) is greatest in the first year of use. It is also higher in selected populations: the obese and those with diabetes and hypertension. VTE remains a rare event. A recent review of all published data by Lidegaard, et al. showed no difference in the risk of VTE with Diane vs. standard OCs. The incidence rate of VTE for women aged 15-44 years taking COCs was 3.4/10,000 years exposure and for women taking Diane-35, it was 3.1/10,000 years exposure. The risk of VTE from COCs is much lower than the risk of pregnancy-related VTE. The risk of VTE in pregnancy is 7.0-9.3/10,000 years.
- Women who are predisposed to coronary artery disease should not take Diane-35® or other oral contraceptives.
- The use of estrogen/progestogen combinations can result in an increased risk for the following conditions:
- thrombophlebitis
- arterial thromboembolism
- pulmonary embolism
- mesenteric thrombosis
- neuro-ocular lesions
- myocardial infarction
- cerebral thrombosis
- cerebral hemorrhage
- hypertension
- liver tumors
- gallbladder disease
- congenital anomalies
Monitoring
- Physicians should complete a thorough history and physical exam prior to prescribing Diane-35® as they would with any OC. Therapy can be initiated as long as the patient goes for a completed gynecological exam by her GP or Gynecologist within the next 3-6 months
- Follow-up exams should be scheduled for 3 months after the initial prescription to monitor improvement of acne and to adjust treatment as necessary. Purely from the point of view of Diane-35 it should be annually thereafter by an Ob/Gyn or GP for the gynecology follow up.
