FDA warns women of deceptive wonder contraceptive.

FDA warns women of deceptive wonder contraceptive.

When Kathleen Thoren expired some time back, her sister Erika was told that she had died from blood clots inside her brain, which had developed due to the negative effects of the contraceptive Ortho Evra.

A year later, the national guard of foods and drugs, the FDA has issued a warning to all consumers of the drug that they are dangerously susceptible to blood clotting in the brain, since the cause estrogen is found in killer levels in Ortho Evra as compared to regular contraceptive pills.

The cautionary message informs the users that whereas the average birth control drug in the market possesses 35 mgms of estrogen, Ortho Evra contains about 60 percent more. The warning said clearly,” In general, increased estrogen exposure may increase the risk of blood clots."

After admitting the new information, the manufacturer of the drug, the US based Ortho-McNeil Inc and a subsidiary of Johnson & Johnson, acquiesced to print the fresh warning on the drug label, post FDA approval. This will be done with immediate effect. The company's internet site is already carrying the requisite message to inform potential end-users as well as the doctor fraternity.

The company's earlier stand had differed wherein it had not differentiated between side-effects of regular pills and their own product.

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The 'wonder drug' Ortho Evra was launched with much fanfare and glitzy advertising in 2002. It was first brought to the UK in year 2003 and was touted as the most revolutionary drug after the oral contraceptive pill. It is like a patch of plaster worn on the skin and releases hormones progesterone and oestrogen, into the blood. The effect of the patch halts the maturing and delivering of ovary eggs, but simulates the metabolic thought in the body that ovulation has taken place. The downside is that the hormones enter the blood directly, are supplied the whole day, are absorbed into the blood system completely and are eliminated differently, hence the prolonged and high estrogen content in the circulation system, leading to high risk exposure and subsequent clotting. In comparison, regular pills are taken orally and enter the digestive tract first, with 50% of the estrogen being eradicated through the digestive system within a few hours of taking the pill.

Initially, the merits of Evra were enumerated as its avoidance of the digestive system, saving women from the terrible bouts of nausea and freedom from daily intake. The direct entry into the bloodstream was considered a boon to boost effectiveness. Worldwide, around 4 million women are estimated to be using it.

However, with the news of 12 users having died with Evra triggered clotting, the pressure on Ortho-McNeil Inc rose. Four months previously The Associated Press reported that Evra users were dying of blood clotting at thrice the rate of those consuming regular pills. The AP reported the issue intensely, quoting incidents where women as young as 20-25 had died due to blood clotting triggered by Evra and others had suffered severe strokes after consistently using the pill. Their families have reportedly initiated legal action against Ortho-McNeil in retaliation.

In response to the vocal opposition, the company has now gone ahead to delineate risks, saying that women who smoke or are prone to clotting or are suffering some forms of cancer should not be using this contraceptive, as it could prove fatal for them. The director of FPA, Toni Belfield, was of the opinion that instead of putting a blind stop to using the product, women should make highly informed decisions after speaking to their doctors.

Bonnie Jacobs, Ortho-McNeil's representative has said that the company has extended full cooperation to FDA. The company is reported to be conducting a study to research and compare how their drug affects clotting vis a vis regular contraceptive pills.