Medications that Cause Birth Injuries Require Clear Labels

The Superior Court of Pennsylvania has recently upheld a jury verdict of $3 million that was awarded to Kelly & Brian Andersen for the cleft palette their daughter developed in 2008 after Kelly Andersen was prescribed Topamax to treat her migraine headaches.

“Topamax is an anticonvulsant drug manufactured by Janssen Pharmaceuticals, Inc. which is a subsidiary of Johnson & Johnson. In their suit, the Andersen’s claimed that Janssen failed to identify Topamax’s potential for causing birth defects on their labels. Even worse, the company did not notify physicians of these potential risks. This created an unnecessary risk for the Andersen’s and many others,” remarked Chicago birth injury attorney John M. Power.

In 2011, the FDA reviewed the risk of birth defects attributed to Topamax and required Janssen to amend their labels. It was a significant move as it is estimated that up to 4% of children will develop cleft palettes when exposed to the drug during the first trimester.

“There are many medications that are known to cause birth injuries. For example, Selectrive Serotonin Reputake Inhibitors (SSRI’s) such as Lexapro, Zoloft, Prozac, and Paxil are commonly prescribed anti-depressants that can cause severe pulmonary problems for newborns. They can also cause cleft lips, Spina Bifida, and limb abnormalities. For this reason, the FDA requires labeling that notifies expectant mothers of these risks,” commented Chicago birth injury attorney John M. Power.

Women who are pregnant have a right to clear labeling of their medications. This includes both prescription and over the counter drugs. It is not outlandish to require pharmaceutical companies to identify the potential birth injuries a medication can cause. Indeed, full disclosure of potential risks is essential to ensuring that patients and their physicians can make safe and informed healthcare decisions.