Monday, February 3, 2014

Contraceptive pill poses risk of blood clots

The Guardian reports Feb 2nd on the risk of fatal blood clots associated with the contraceptive pill but then down play the story and minimize the risks. The question that arises immediately is are the risks being minimized for ideological reasons? Is access to the contraceptive pill considered to be more important than a woman’s life or health?
The article references a report that France’s drug safety agency has found a link between sometimes-deadly blood clots and third- and fourth-generation contraceptive pills. The National Agency for Drug and Health Product Safety (ANSM) in France estimates about 20 women die each year in France of blood clots connected to contraceptive use.

The Guardian article reads
Women in England using some of the most popular brands of contraceptive pill are to be warned that they carry a risk of fatal blood clots.

The Medicines and Healthcare Products Regulatory Agency (MHRA) told GPs the risks posed by combined hormonal contraceptives [CHC], which contain two different female hormones, an oestrogen and a progestogen, were small and the benefits outweighed them but that women should understand those risks.

The advice for GPs states: "The decision to use any CHC should be taken only after a discussion with the women to ensure she understands: the effect of any intrinsic risk factors on her risk of thrombosis [eg deep vein thrombosis, pulmonary embolism, heart attack and stroke]; the risk of thromboembolism with her CHC; that she must be alert for signs and symptoms of a thrombosis."

An alert was issued by the MHRA to GPs on 22 January after the European Medicines Agency (EMA) said in November that the product information for CHCs containing certain synthetic progestogen should be updated.

The EMA launched a review after France's drug safety agency estimated that about 20 women die each year in France of blood clots connected to contraceptive use.

The EMA concluded: "The benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE [venous thromboembolism] with all CHCs is small."

The agency found that the risk of blood clots in the veins varies between CHCs, ranging from five to 12 cases per 10,000 women who use them for a year, compared with two cases each year per 10,000 women who are not using CHCs.

A checklist for prescribers provided by the MHRA says a CHC should not be prescribed to certain women, including those with a history of a thromboembolic event or with very high blood pressure, those who have had major surgery, or have a period of prolonged immobilisation coming up.

It says the suitability of a CHC should be discussed with a woman if they have certain risk factors including age, obesity and smoking and that if exposed to more than one of those risk factors it "may mean a CHC should not be used". The MHRA advises that CHCs containing ethinylestradiol, a synthetic form of oestrogen, in combination with certain kinds of synthetic progestogen – namely levonorgestrel, norgestimate, or norethisterone – are considered to have the lowest risk of VTE.

A user card and patient information sheet are also provided, detailing the risk. The former says: "The overall risk of a blood clot is small but clots can be serious and may in very rare cases even be fatal." Women are warned to seek immediate medical attention if they experience symptoms including severe pain or swelling in either leg, sudden unexplained breathlessness, weakness or numbness of the face, arm or leg.

Dr Sarah Branch, deputy director of the MHRA's vigilance and risk management of medicines division, said: "Women should continue to take their contraceptive pill. These are very safe, highly effective medicines for preventing unintended pregnancy and the benefits associated with their use far outweigh the risk of blood clots in veins or arteries."