With the growing numbers of claims in the US alleging an increased risk of pulmonary embolism and other severe side-effects from the oral contraceptive Yasmin, a court in New Jersey has requested that the actions be centralised and given mass tort status.

The US litigation includes three "fourth generation" oral contraceptives Yasmin and Yaz products manufactured by Bayer Healthcare Pharmaceuticals and Ocella manufactured by Barr Pharmaceutical Companies. Women who have filed claims in various States allege that they have suffered strokes, DVTs and other problems including raised potassium levels which may increase the risk of complications for women with a range of conditions including obesity, renal problems, diabetes, chronic high blood pressure or a history of stroke and DVT.

The claims allege that the drugs contain oestrogen and progesterone, which suppress ovulation and prevent pregnancy. It is alleged that they also contain drospirenone, an ingredient not found in other oral contraceptives which is alleged to differ from other progesterones in the US and not previously marketed in this country before its use in these 3 drugs. Drospirenone has been associated with health risks not seen in other forms of the hormone.  In August 2009 the British Medical Journal published two studies identifying an increased risk of venous blood clots for women taking drospirenone when compared with women who had taken other oral contraceptives. The BMJ referred to 40 cases in which women had suffered venous thrombosis, including one involving the death of a 17 year old. The BMJ reports that the Dutch College of General Practitioners has recommended that its members prescribe the older forms of second generation birth control pills rather than Yasmin and Yaz. Between 2004 and 2008 in excess of 50 deaths associated with the use of Yasmin and Yaz have been reported to the US FDA. On 5 August 2009 the US Food & Drug Administration issued a warning letter to Bayer after it was alleged to have used low-quality batches of drospirenone from a plant in Germany.

Michelmores' clinical negligence team provide a link to the netdoctor website setting out information on Yasmin, its active ingredients, guidance for use and warnings.  Click here

http://www.netdoctor.co.uk/medicines/100004704.html