Vikela ("morning after pill") over the counter
As of Dec. 17, 2009, Vikela 1.5 mg tablet (levonorgestel) was made available without a prescription to women of all ages by a decision proposed by the Federal Office for Safety in Health Care (BASG). When used correctly, Vikela is a relatively safe method of preventing unwanted pregnancy after unprotected sexual intercourse or when a contraceptive method fails. The drug was approved in Austria in 2005.
Emergency contraception is most effective when taken preovulatory (before ovulation), and administration of levonorgestel in a single dose of 1.5 mg or 2x750 µg is medically safe. The prescription requirement meant that rapid and timely availability within 72 hours of unprotected intercourse was not available to many women.
Currently, Vikela is available without a prescription in Belgium, Finland, France, the Netherlands, Sweden, Norway, Denmark, Estonia, Iceland, Latvia, Luxembourg, Portugal, Slovakia, Switzerland, and the United Kingdom.
Side effects in clinical trials:The following table shows the frequency with which side effects have been reported in clinical trials.
Side effect | Frequency of occurrence in two clinical studies* (in percent) |
Nausea | 14-24,3 |
Lower abdominal discomfort | 14-15,6 |
Fatigue | 14** |
Headache | 10-21,3 |
Dizziness | 10-12,6 |
Tightness in the chest | 8-12,9 |
Vomiting | 1-7,8 |
Heavy menstrual bleeding | 15,5*** |
Diarrhea | 4** |
Bleeding | 31** |
Delayed menstruation | 5-19.9**** |
*Study 1 (n=544): Contraception, 2002, 66, 269-273
*Study 2 (n=1359): Lancet, 2002, 360:1803-10.
** Not reported in study 1.
*** Not reported in study 2.
**** Definition: delay defined as more than seven days.
The side effects mentioned usually disappear within 48 hours of taking Vikela. Breast tenderness, spotting, and intermenstrual bleeding were observed in up to 30 percent of women and may persist until the following, possibly delayed, menstrual bleeding. Hypersensitivity reactions of the skin have been reported after taking Vikela.
Notice:
BASG / AGES PharmMed point out that an emergency contraceptive in no way replaces a regular contraceptive method; likewise, it does not protect against sexually transmitted diseases. It also does not prevent pregnancy in every case, especially if there is uncertainty about the exact time of unprotected sexual intercourse. Therefore, a check-up by a gynecologist specialist is strongly recommended!
Further information:
Further inquiries:
Univ-Prof. Dr. Marcus Müllner
Phone: +43 (0) 664 839 81 43
E-mail: pr_pharmmed@ages.at
