Pill poses threat of blood clots, GPs warned

The danger of blood clots in the veins varies between CHCs, ranging from five to twelve circumstances per 10,000 girls a 12 months, in contrast with two circumstances a year per ten,000 ladies who are not utilizing the combined pill. Photograph: Stockbyte/Getty Images

Ladies in England making use of some of the most well-known brands of contraceptive pill are to be warned that they carry a chance of fatal blood clots.

The Medicines and Healthcare Merchandise Regulatory Agency (MHRA) advised GPs the hazards posed by mixed hormonal contraceptives [CHC], which incorporate two diverse female hormones, an oestrogen and a progestogen, were small and the benefits outweighed them but that females must recognize those risks.

The tips for GPs states: “The determination to use any CHC must be taken only following a discussion with the ladies to guarantee she understands: the effect of any intrinsic chance elements on her chance 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 indications and signs of a thrombosis.”

An alert was issued by the MHRA to GPs on 22 January following the European Medicines Agency (EMA) mentioned in November that the merchandise info for CHCs containing specified synthetic progestogen must be updated.

The EMA launched a review after France’s drug security company estimated that about twenty girls die each and every 12 months in France of blood clots linked to contraceptive use.

The EMA concluded: “The benefits of CHCs in stopping undesirable pregnancies carry on to outweigh their risks, and that the nicely-acknowledged chance of VTE [venous thromboembolism] with all CHCs is tiny.”

The company found that the risk of blood clots in the veins varies amongst CHCs, ranging from five to 12 instances per 10,000 girls who use them for a year, compared with two situations every single 12 months per ten,000 ladies who are not making use of CHCs.

A checklist for prescribers offered by the MHRA says a CHC should not be prescribed to specified ladies, including people with a history of a thromboembolic event or with quite high blood pressure, people who have had significant surgical procedure, or have a time period of prolonged immobilisation coming up.

It says the suitability of a CHC need to be mentioned with a female if they have specified risk elements which includes age, obesity and smoking and that if exposed to far more than one of those threat aspects it “might mean a CHC must not be utilised”. The MHRA advises that CHCs containing ethinylestradiol, a synthetic type of oestrogen, in mixture with particular sorts of synthetic progestogen – namely levonorgestrel, norgestimate, or norethisterone – are regarded to have the lowest threat of VTE.

A user card and patient details sheet are also supplied, detailing the risk. The former says: “The overall danger of a blood clot is small but clots can be critical and could in really uncommon situations even be fatal.” Women are warned to look for quick health care attention if they experience signs and symptoms such as significant soreness 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 danger management of medicines division, stated: “Ladies should proceed to get their contraceptive pill. These are really risk-free, hugely efficient medicines for preventing unintended pregnancy and the benefits connected with their use far outweigh the risk of blood clots in veins or arteries.”

Pill poses threat of blood clots, GPs warned