Personal Injury Law

Have Yasmin-Related Blood Clot Side Effect Cases Flown Below Radar In US?

By Tom Lamb

In Europe Reports Of Pulmonary Embolism And Deep Vein Thrombosis Were Made Soon After Yasmin Birth Control Pill Was Approved in 2000

(Posted by Tom Lamb at DrugInjuryWatch.com)

An April 13, 2002 BMJ article, "Dutch GPs warned against new contraceptive pill" (FREE registration required), was published the week before the Yasmin birth control pill was going to become available to women in the United Kingdom.  From that article we learn, now, that Yasmin was the subject of safety concerns right from the start in Europe:

Dutch GPs are being advised by their own professional body not to prescribe a new low dose, monophasic oral contraceptive, marketed under the trade name Yasmin, until studies have established whether it is as safe as other contraceptive pills.

The new contraceptive, which is a combination of drospirenone (a progestogen) and ethinylestradiol, has been available in several European countries since 2000 and was approved by the US Food and Drug Administration last May. It is licensed for use in the United Kingdom, where it is being launched next week.

Last year a 17 year old Dutch girl who had been taking Yasmin died from a venous thrombosis. Although no direct link with Yasmin has ever been shown, 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal, have now been reported in Europe.

The Dutch College of General Practitioners has now reiterated its position that GPs should continue to choose the second generation pill, because of the lack of epidemiological data on the risk of thrombosis from Yasmin.

About a year later, in the February 1, 2003 edition of BMJ, there appeared a brief Drug Points piece, "Thromboembolism associated with the new contraceptive Yasmin", which provided some details about several cases of serious blood clot side effects in women using the Yasmin birth control pill.

Our centre, the Dutch spontaneous reporting system for adverse drug reactions, recently received five reports of thromboembolism as a suspected adverse drug reaction to the new oral contraceptive Yasmin (ethinylestradiol and drospirenone).

A 17 year old woman suddenly collapsed and died after taking the contraceptive [pill Yasmin] for six months. Autopsy showed that she had had a massive pulmonary embolism [(PE)]. No obvious risk factors for thromboembolism, such as smoking, a period of long immobilisation, air flights, or concomitant medication, were evident....

A 28 year old woman changed her oral contraceptive from ethinylestradiol with desogestrel (Marvelon) to ethinylestradiol with drospirenone [(Yasmin)]. Four months later she had thrombosis in one leg and was treated with acenocoumarol. Risk factors or concomitant drugs were unknown.

Another patient, a 45 year old woman, had deep vein thrombosis [(DVT)] in one leg after taking ethinylestradiol with drospirenone [(Yasmin)] for two months, as did a 50 year old woman who took the contraceptive for three months.

A 35 year old woman had pulmonary thrombosis 17 days after she started taking the contraceptive [pill Yasmin]. She had given birth four months earlier.

Only recently in the U.S. have there been products liability lawsuits filed on behalf of women who have developed a pulmonary embolism (PE) or deep vein thrombosis (DVT) after they used Yasmin -- or YAZ, a newer but very similar birth control pill that also contains the so-called "fourth generation" progestin drospirenone (DRSP).

We expect, however, to see an increasing number of Yasmin lawsuits -- and YAZ lawsuits -- as more women learn about the blood clot side effect risks associated with these "fourth generation" oral contraceptives only after they suffered a pulmonary embolism (PE) or a deep vein thrombosis (DVT).

Full post as published by Drug Injury Watch on June 11, 2009 (boomark / email).