Saturday, March 12, 2011

Two Drug Warnings for Pregnant or TTC Women

Wanted to let you know about a couple of drugs which pose significant risks to women and their fetuses.

Terbutaline is an asthma drug, available in oral and injectable form. For many years, it has been used "off-label" to prevent or delay pre-term labor, a use for which it was never approved. Despite evidence that the injectable drug doesn't have any benefit after being given for 3 days, and that the oral form of the drug doesn't work at all for this use, some women are still being given the drug in ways which simply don't work, and suffering cardiovascular events as a result. At least 16 pregnant women are thought to have died from the unapproved use of Terbutaline. The FDA has finally stepped up to the plate and now requires Terbutaline to carry a "black box warning" in order to prevent further deaths and injuries.

Here are the new guidelines and warnings re Terbutaline.

Topiramate (brand name Topamax) is a drug used for treatment of epilepsy and prevention of migraines. It is also used off-label for treatment of bipolar disorder. The FDA recently reclassified it as a Pregnancy Category D drug, meaning that it has been demonstrated to pose a risk to fetuses, but that in some cases the benefits to the pregnant woman may outweigh the risks to her child. The FDA took this action after evidence that Topiramate significantly increased the risk of a child being born with an oral cleft (cleft lip or cleft palate).

Here is some info from the FDA re the new risk assessment of Topiramate in pregnancy.

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