Topamax Pregnancy Risk Label Change
The United States Food and Drug Administration (FDA) now requires that Topamax labels carry strict warnings for pregnant women. Recent research shows that women who take Topamax while pregnant have a much higher risk of delivering infants with cleft lip or cleft palate (collectively known as oral clefts).
Doctors prescribe Topamax for migraine headaches or epileptic seizures. The new label will warn women of the risks of Topamax before taking the drug. The changes will also help doctors become more aware of the possible problems facing pregnant women who take this medicine.
Growing List of Harmful Medication for Pregnant Women
Doctors began researching the effects of medicine on unborn children in the 1960s. Until then, doctors knew little about medications’ potential for causing birth defects. Thalidomide was one of the first drugs known to cause birth defects and was linked to many babies being born with shortened and deformed limbs. Since then, researchers have studied the effects of drugs to make sure they are safe for pregnant women to take.
Because it is unethical to knowingly give pregnant women a drug that might harm them or their unborn children, drug dangers in pregnancy take a long time to appear. As drugs spend more time on the market, more dangers are realized through post-market research.This means the FDA, doctors and patients have to wait for enough people to take the drug that trends of the negative side effects emerge. For instance, one popular asthma medication, terbutaline, turned up unexpectedly as a cause for heart problems in pregnant women. Yet another study showed that strong pain relievers like Tylenol with Codeine and Vicodin can be dangerous to unborn babies if taken early in pregnancy. In some cases, opioid pain relievers even caused problems if taken just before pregnancy occurs.
Doctors Might Not Realize Drugs are Harmful
Researchers work as quickly as possible to find out which medicines are harmful for pregnant women. Unfortunately, many different medications can endanger an unborn child or a pregnant mother. In most cases, doctors do not realize there is a problem with a medication until a trend of birth defects becomes evident. Only after a pattern of infant illnesses becomes prevalent can doctors say that a medicine might have caused the problem.
Even Over-the-Counter Medicine Could Cause Problems
Prescription medications are not the only possible sources of danger for pregnant women and their unborn children. Some over-the-counter drugs can cause injury. Many experts tell pregnant women to avoid common medicines like Ibuprofen during the later parts of their pregnancies to avoid excessive bleeding during childbirth. Decongestants with pseudoephedrine can also seriously harm a fetus early in pregnancy.
If you or someone you love has a child with birth defects that you think might have been caused by a drug, contact our office right away. You may be eligible for compensation to pay for your child’s ongoing medical needs. Our experienced and professional attorneys will meet with you at no cost and help you choose the best course of action for your situation.