A panel of experts at the federal Food and Drug Administration (FDA) has voted to loosen restrictions on a diabetes drug that has been linked to heart problems. The drug, rosiglitazone (brand name Avandia), was once one of the industry's highest sellers, with an estimated $3 billion in sales per year for its manufacturer, GlaxoSmithKline, until evidence in 2007 revealed that it increased the risk of heart problems. Now Avandia is used by just a few thousand people.
Recently, 13 out of 26 people on the FDA advisory panel voted to amend the restriction on sales, which had been imposed in 2010. The restrictions stated that Avandia could only be used as a last resort medication, after patients had not responded to other drugs, that it be sold only at certain pharmacies, and that physicians and patients must acknowledge that they understand the increased risk of a heart attack. Those who began taking Avandia prior to the imposed restrictions are not affected.
The panel's vote in favor followed the outcome of a review of a clinical trial conducted by the manufacturer, which purported to find that Avandia did not increase the risk of heart problems. Even so, some of the panel members who voted in favor continued to express reservations about the drug. The FDA is expected to follow the panel's lead, as it normally follows its advisory panels' recommendations.
It is fortunate for those who need the drug if Avandia does not pose a greater risk of heart attack or other heart problems. Unfortunately, that is not the case for many medications -- a pregnant woman who takes certain necessary medications, such as antiepileptic drugs -- has an increased risk of giving birth to a child with a birth defect. For instance, Depakote, one drug used to treat epilepsy and migraines, has been revealed to cause birth defects in certain animal studies, and shows evidence of causing birth defects in humans. As a result, Depakote went from being classified as FDA pregnancy category C -- only posing a risk to animal fetuses -- to pregnancy category D, a classification that shows it capable of greater harm. Any woman who takes this medication must take precautions, and must be fully informed of the risks by her physician before she proceeds.
If your child has a birth defect that you believe is due to your taking a dangerous antiepileptic drug while pregnant, you have the option of hiring an experienced attorney and filing a product liability lawsuit against the manufacturer and/or a medical malpractice lawsuit against your physician. You might argue in your product liability lawsuit that the manufacturer created an unreasonably dangerous drug, exposure to which caused your child's birth defect. In your medical malpractice lawsuit, you would argue that your physician had a duty to inform you of all of the risks of a potential treatment, yet failed to do so. As a result, you were unknowingly exposed to a dangerous drug and your child was born with a birth defect.