Texas’ abortion drug bill: More side effects and higher costs

Posted: Published on December 30th, 2012

This post was added by Dr P. Richardson

A GOP lawmaker is looking to make Texas the latest state to restrict the use of abortion medications in a way that some experts warn could increase the drugs side effects while making them more expensive.

Anti-abortion activists and legislators cant enact an outright ban on abortion-inducing drugs like mifepristone (formerly known as RU-486). Instead, they have sought to force doctors to strictly adhere to U.S. Food and Drug Administration guidelines that appear to be significantly out of step with the current scientific understanding of how the medications should be used.

Lawmakers have passed abortion drug restrictions in Arizona and Ohio, overcoming legal challenges. The Oklahoma Supreme Court recently ruled that similar legislation in that state was unconstitutional. A North Dakota bill is currently tied up in litigation.

In Texas, state Sen. Dan Patricks bill, which mirrors model legislation drafted by anti-abortion group Americans United for Life, would require doctors who prescribe an abortion drug to follow the protocol outlined in the official drug label approved by the FDA. He introduced similar legislation in 2011 with the AULs support but it didnt pass. Patrick also authored the states controversial pre-abortion sonogram law.

In most states, doctors arent required to abide by the FDA guidelines. And since the FDA only regulates the drug market and not the practice of medicine, off-label treatment isnt against federal law either. In fact, the FDA itself notes that physicians may prescribe a medication off-label as long as they are well informed about the product and base its use on firm scientific rationale and on sound medical evidence.

AUL insists that off-label use of mifepristone can be deadly. While Patrick did not respond to interview requests from The American Independent, he said the intent of [the bill] is to improve the doctor-patient relationship in an email to the Texas Tribune. But the legislations strict adherence to the FDA guidelines worries reproductive health care advocates and medical experts. They say a substantial body of recent research shows that the mifepristone drug label is outdated, potentially creating unnecessary burdens, financial costs, and health risks for women.

During a medical abortion, mifepristone is given to the woman at the clinic. The second round of medicine, misoprostol, is taken a day or two later to help end the pregnancy.

The FDA guidelines say that women should take 600 milligrams of mifepristone. But 2012 World Health Organization guidelines recommend a lower dose of mifepristone. Citing several studies, the report states that 200 mg of mifepristone is the dosage of choice, since it is as effective as 600 mg, and reduces costs when it is followed by a dose of misoprostol.

Some of the language in Patricks bill is ambiguous, but it appears that it would also require women to receive their second dose of abortion pills the misoprostol in the presence of her doctor rather than at home, where it is typically taken. A number of reproductive health advocates find that rule troubling.

According to the National Abortion Federation, the majority of women who take mifepristone will abort within four hours of using misoprostol. Because of this, most women choose to take the misoprostol dose in the comfort of their own home due to painful side effects such as cramping and excessive bleeding that can also occur within the first few hours. Nausea, vomiting and fever are among the other side effects women may experience, according to NAF.

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Texas’ abortion drug bill: More side effects and higher costs

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