Visanne Adverse Reactions

Presentation of undesirable effects is based on MedDRA.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Undesirable effects are more common during the first months after the start of treatment with Visanne, and subside with continued treatment. There may be changes in bleeding pattern, such as spotting, irregular bleeding or amenorrhea. The following undesirable effects have been reported in users of Visanne. The most frequently reported undesirable effects under treatment with Visanne are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).
In addition, the majority of patients treated with Visanne experience changes in their menstrual bleeding pattern. Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the WHO 90 days reference period method. During the first 90 days of treatment with Visanne the following bleeding patterns were observed (n=290; 100%): Amenorrhea (1.7%), infrequent bleeding (27.2%), frequent bleeding (13.4%), irregular bleeding (35.2%), prolonged bleeding (38.3%), normal bleeding, i.e. none of the previous categories (19.7%). During the fourth reference period the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (2.7%), irregular bleeding (21.5%), prolonged bleeding (4.0%), normal bleeding, i.e. none of the previous categories (22.8%). Changes in menstrual bleeding patterns were only occasionly reported as adverse event by the patients (see table).
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Visanne are summarized in the following table. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). The frequencies are based on pooled data of four clinical trials, including 332 patients (100%). (See table.)

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Decrease of bone mineral density: In an uncontrolled clinical trial with 111 adolescent women (12 to <18 years) who were treated with Visanne, 103 had BMD measurements. Approximately 72% of these study participants experienced a decrease in BMD of the lumbar spine (L2-L4) after 12 months of use (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.