Bayer to update labels for Yaz and Yasmin: FDA

Reports from the Royal Women's Hospital show that more than one million women in Australia take the pill, yet some of them may not be aware of the risks involved with certain oral contraceptives.

In the US health officials are calling for stricter labelling on new generation birth control pills Yaz and Yasmin.

The decision comes after a review by the American Food and Drug Administration into health and marketing practices at Bayer.

Regulators said the company had failed to pass on important research findings showing an increased risk of blood clots among women using these versions of the pill.

In a report that was released earlier this week (December 6), panellists said that research about the effects of the compound drospirenone – a type of progestogen – on women were known to the brand and more needed to be done to uphold acceptable health standards.

"Because of the consistency in recent reports for an increased risk, product labelling should reflect that very real possibility," they said.

According to the Therapeutic Goods Administration (TGA) most oral contraceptives contain two types of hormones namely, oestrogen and progestogen, which work together to stop the body ovulating.

Earlier this year a British medical journal published two reports warning women that taking Yaz or Yasmin could increase their risk of developing potentially-fatal blood clots.

And any women taking these versions of the pill have since been advised to contact a doctor if they show signs of persistent leg pain, severe chest pain or even shortness of breath in countries such as Australia, Canada and the US.

In July, the Australian TGA suggested that women with prescriptions for Yaz or Yasmin contact their medical professional if they experienced any discomfort while using these drugs.

Cynthia Pearson, executive director of the National Women's Health Network, represents one of the many consumer groups that feel the drugs should be taken off the market due to their adverse effects.

Speaking about the decision not to update their labels, as well as the risk of blood clotting in older women, Ms Pearson said: "While it's rare, it's heartbreaking when this happens. When there are safer options available, we can't let this continue."

In the US, Yaz has for many years been one of the top-selling contraceptives on the market – with sales reaching the US$374 million mark last year.

The product's popularity with women of all ages may have been boosted by its ability to effectively treat acne and severe mood swings such as premenstrual dysphoric disorder.