With a prayer and a pill, how could it fail?

MEDICAL MATTERS:THE PILL was 50 years old last Saturday. Or was it? No one is really sure when to celebrate its birthday. Ten years ago, the US Food and Drug Administration (FDA) honoured the occasion on June 23rd, the date that it gave formal approval for Searle to market its new product, Enovid. This year, the agency is celebrating on May 9th, which coincides with the period 50 years ago when it announced its intention to approve the pill after it asked the pharmaceutical company to fine-tune its application.

The combined oral contraceptive (to give it its formal medical name) broke ground other than the huge social change it presaged. It was also a landmark in how regulatory agencies dealt with safety issues surrounding new drugs. The pill had a rocky initial road, with rising concerns about its safety.

In November 1961, a case report in The Lancet said a young woman had developed a blood clot and died while taking the pill. Within months, two similar fatalities were reported in the US, and nine months later the FDA had reports of other women on the pill who had suffered blood clots.

By 1965, the FDA had established its first permanent advisory panel, the Obstetrics and Gynecology Advisory Committee, primarily to track the safety of the pill. Indeed, many of the routine steps now used to assess drug safety throughout the world, such as routine referrals to outside experts and the ongoing assessment of a medicine’s safety, emerged in response to concerns about the pill’s safety.

The combined contraceptive has continued to develop in many ways in the intervening years. The oestrogen dose in modern pills is much less than in the original, substantially reducing the risk of deep venous thrombosis.

Newer forms of oestrogen and progestogen – the other hormone used in the combined pill – have emerged. And the delivery methods, in particular, have mushroomed: you can now apply a skin patch; have a rod containing the ingredients inserted under your skin as a long-term option; or use a vaginal ring containing the combined contraceptive agents.

Other than different formulations, probably the biggest driver of change has been the impetus to produce a pill with the lowest effective dose and the cleanest side effect profile.

Apart from rare cardiovascular events, pill users may experience a number of side effects including nausea, tummy bloating, breakthrough bleeding, breast discomfort, mood change and a reduced libido. For women who experience nausea, it may be worth trying Evra, a patch attached to the skin on a weekly basis.

Another problem is bloating. “This is considered to be an oestrogen effect,” says Dr Mary Davin Power, a continuing medical education tutor with the Irish College of General Practitioners. She suggests trying a lower oestrogen dosage if bloating persists.

For women with a reduced libido, she suggests moving to a 20 microgramme pill or trying a non-oral formulation. Moodiness is probably related to the progestogen component of the pill, so changing to a more oestrogenic version may help.

“However, typically combined oral contraceptive effects are mild and self-limiting, so new users or those who have recently switched pills should be advised to try to persevere with any given brand for three months,” she says.

So what are the latest pills to hit the market? Both Yaz and Yasminelle contain a progestogen called drospirenone, which differs in having diuretic properties; this feature should help reduce problems with fluid retention.

Qlaira contains oestradiol valerate, a “natural oestrogen”, and is presented in a unique “step down, step up” dosing.

However, for more forgetful souls, it could be a nightmare. It has the most complicated missed-pill routine I have ever seen.

I’ll finish on a lighter note. In the early days of contraceptive use in Ireland, some doctors took perverse pleasure in advising women to use the Angelus as a reminder to take their daily pill.

With a prayer washing down the pill, sure how could it fail?