Contraceptive pill Yasmin continues to stir debate
Following concerns that contraceptive pills containing the synthetic hormone drospirenone carry an increased risk of blood clots, panel members of the US Food and Drug Administration (FDA) met in December to vote on whether the benefits outweighed the risks. They voted 15-11 in favour. However, research carried out by the Washington Monthly and the British Medical Journal (BMJ) has since found that four of the panel members had links to Bayer, the pharmaceutical company that manufactures two of the best known drospirenone-containing pills, Yaz and Yasmin.
Their relationships with Bayer were known to the FDA at the time of the review, but were not considered to be a cause for a "conflict of interest". All four panel members voted in support of drospirenone-containing pills. Meanwhile, another panel member with known concerns about drospirenone-containing products was, only days before the vote, prevented from taking part due to a "conflict of interest".
Such claims have served to further muddy the waters around the controversial pill, and will be of concern to many women - four million according to Bayer - who take Yasmin alone. Although health authorities and the Ministry of Health insist that it requires a prescription, it is still readily available over the counter in pharmacies in the UAE.
Thousands of lawsuits are currently pending in the US over alleged injuries and deaths as a result of the use of such pills, according to Bayer's annual report. Other birth control pills containing drospirenone are Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.
The BMJ claimed last year that, according to studies carried out in the US and UK, the risk of deep vein thrombosis (DVT) was two to three times higher in women between the ages of 15 and 44 who are taking birth control pills containing the hormone drospirenone, than those who are taking pills containing a different hormone, levonorgestrel. A deep vein thrombosis is a blood clot that forms in the veins of the leg and can break loose. If it reaches the lung, it can cause a potentially fatal pulmonary embolism.
"Prescribing lower-risk levonorgestrel preparations as the first-line choice in women wishing to take an oral contraceptive would seem prudent," said the researchers in the British study. They added, however, that the overall risk of blood clots in women taking drospirenone-containing pills was still very low. Microgynon is one of the better-known birth control pills containing levonorgestrel.
Although the results of these studies support earlier findings, others have reported no increased risk. The conflicting claims prompted the FDA to review the studies, culminating in the vote in December.
Most contraceptive pills contain two hormones, oestrogen and progesterone, which prevent the ovaries from releasing eggs and alter the cervical mucus and womb lining to prevent pregnancy. As well as a method of birth control, pills containing drospirenone are sometimes prescribed to treat premenstrual dysphoric disorder (PMDD), polycystic ovaries and moderate acne. They can also help to reduce water retention.
All birth control pills raise the risk of blood clots, and women who smoke, are over 35 or have a history of blood clots in their family are most at risk and should avoid taking oral contraceptives altogether. So how should we react to these findings?
"Yasmin is one of the most used pills," says Dr Meltem Tank, an obstetrician-gynaecologist at the Swedish Medical Centre in Abu Dhabi, "and 99 per cent of women are very happy with it. I haven't seen a case in which Yasmin is causing more clotting than any other pill, in my experience."
Others, though, are more anxious. "Of course I am very concerned about this," says Dr Anna Sepiolo, an obstetrician-gynaecologist based at the Dubai London Clinic in Umm Suqeim. "If people are taking this pill and are worried about it, they should discuss it with their gynaecologist to find which method of contraception is best for them."
Contraceptive pills are not for everyone, she adds. "You need to take into account family history, gynaecological history, surgical history, previous pregnancies and age. There are many different contraceptive methods now, including injections, patches and intrauterine devices. Which one is best depends entirely on the patient."
"You never know, from one year to the next, what they are going to say about the contraceptive pill," says Dr Amira El Sayed, a consultant family physician at Al Mushrif clinic in Abu Dhabi (part of Sheikh Khalifa Medical City) who specialised in obstetrics and gynaecology in Egypt and Saudi Arabia. "The research and studies are going on and on. At one point, everyone was advocating HRT [hormone replacement therapy], saying how it can decrease cardiovascular disease and osteoporosis. And then suddenly, they were saying there is a correlation between it and breast cancer."
When it comes to the contraceptive pill, El Sayed is not a fan, favouring instead a form of intrauterine device (IUD), which is inserted into the uterus and secretes a small amount of the hormone levonorgestrel daily. "The oral contraceptive pill contains two hormones - oestrogen and progesterone - and when you take two hormones it has more side effects. The IUD has a very small progesterone effect - 25 micrograms. Also, you have to remember to take the pill for it to be effective."
However, since IUDs can be implanted and remain in the uterus for up to five years, they are not recommended for women who have yet to have children. "Here, where women often want lots of children," says El Sayed, "and want, for instance, only one year off, I would prescribe them the oral contraceptive pill."
And El Sayed has her own reasons for being wary of the pill. "I myself am a breast cancer survivor and the pill is the only thing I took when I was young, so perhaps that contributed. I am a little wary of giving it to my patients for a long time."
The UK government agency MHRA (Medicines and Healthcare products Regulatory Agency) is advising women not to overreact, though. "If you take Yasmin," reads the Advice for Women section on its website, "there is no need to stop doing so on the basis of these findings. When used appropriately, the benefits of all combined oral contraceptives, including Yasmin, far outweigh the risk of VTE (Venous thromboembolism)."
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Published: March 12, 2012 04:00 AM