Birth control app facing UK inquiry is approved in US as contraceptive

A BIRTH control app under investigation in the UK after reports of unwanted pregnancies has been given the green light to be advertised as a contraceptive by US drug regulators.

The Food and Drug Agency said the app, Natural Cycles, was the first of its kind to be marketed in the US.

Natural Cycles’ algorithm calculates the days of the month a woman is likely to be fertile. It takes body temperature readings and menstrual cycle information into account, building on a traditional method called fertility awareness.

The app costs around £7 per month and has more than 700,000 users. It claims to be the only certified birth control app in Europe. However, it is not regulated by the British Medicines and Healthcare Product Regulatory Agency.

The British Advertising Standards Agency is investigating Natural Cycles over its Facebook advertising campaign in which it described its service as “highly accurate”. In January, doctors in Sweden notified the Swedish Medicines Agency after 37 women who claimed to be using the app became pregnant over a four-month period.

Terri Cornelison, of the FDA’S Centre for Devices and Radiological Health, said: “This new app can provide an effective method of contraception if it’s used carefully and correctly. But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage.”

Clinical studies to evaluate the app involved 15,570 women who used it for an average of eight months. The app had a “perfect use” failure rate of 1.8pc, which means 1.8 in 100 women who use it for one year will become pregnant because they had sex on a day when the app predicted they would not be fertile – or because their contraceptive method failed when they had sex on a fertile day.

The app, created by Swedish couple Dr Elina Berglund and Dr Raoul Scherwitzl, was previously allowed to be sold as a fertility monitor in the US.