It is easy for mothers-to-be to become overwhelmed with advice about what
they should do to assure the health and safety of their unborn children.
Expecting mothers must make sure they are eating right, getting the proper
amount of exercise and following their doctor’s advice.
Unfortunately, as a recent spate of warnings from the Food and Drug Administration
(FDA) demonstrate, mothers-to-be must also watch carefully which prescription
drugs they are taking to assure the safety of their unborn children.
The Dangers of Topamax
Just a few weeks ago, the FDA reiterated warnings that pregnant women who
take topiramate (sold under the brand name Topamax) – an anticonvulsant
medication used to treat seizure disorders including epilepsy and migraine
headaches – have an increased risk of giving birth to children with
cleft lips or cleft palates. This new warning comes after review of information
compiled by the North American Antiepileptic Drug (NAAED) Pregnancy Registry,
which confirmed a higher incidence of these sorts of birth defects among
children who were exposed to topiramate during the first trimester of
According to the NAAED, women who are currently taking Topamax should seek
advice from their doctors and use birth control to assure that they do
not become pregnant. Pregnant women who currently use Topamax are advised
to continue taking the drug until they receive further advice from their
The FDA has classified topiramate as a Pregnancy Category D Drug, which
means that there is evidence of human fetal risk, but the potential benefits
from the use of the drug by pregnant women may make use of the drug acceptable
despite the risks.
Dangers Continue to Mount
The recent announcements regarding the dangers posed by Topamax are just
the latest in a series of announcements about drugs that have been found
to cause harm to mothers-to-be and their babies.
Earlier this year, the FDA announced that newborns whose mothers had taken
antipsychotic drugs like Haldol, Zyprexa, Seroquel and Abilify during
pregnancy may experience symptoms of withdrawal like agitation and difficulty
breathing and eating for hours or days after birth.
In addition, the Centers for Disease Control and Prevention (CDC) warned
that taking opioid pain relievers like Vicodin, OxyContin and Tylenol
with codeine just before or early on in pregnancy may increase the risk
of birth defects including heart defects and glaucoma.
What may come as a surprise to many is that information about the dangers
prescription and over-the-counter pharmaceuticals may cause to unborn
children is often lacking. The problem is, of course, that it is considered
unethical to involve pregnant women in the kinds of clinical trials required
by the FDA before a drug is considered safe for use.
Despite this lack of data, most pregnant women take prescription drugs
during pregnancy. According to one study, 64 percent of pregnant women
take at least one prescription medication, but most take between three and five.
How Can Mothers-to-Be Keep Themselves and Their Children Safe?
It is widely agreed that women should not go nine months without treating
conditions such as asthma, epilepsy, depression and other serious health
conditions. Going that long without treatment not only puts the health
of the mother at risk, but also her unborn child.
Experts recommend that pregnant women meet often with their physicians
and discuss treatment options for chronic conditions and other health
problems. Although it can, of course, be difficult to determine which
drugs are safe, some changes to drug labeling rules may make it easier
for women to make informed decisions about their care during pregnancy.
The FDA is currently working to finalize a rule requiring each drug label
to list the known pregnancy risks of the drug, as well as information
for doctors. In addition, the FDA is currently working with drug makers
on rules for safely including pregnant women in clinical trials, a change
that would lead to more information about how drugs work during pregnancy.
No matter what, the unfortunate truth is that mothers do not discover that
the drug they took during pregnancy is dangerous to their unborn child.
Indeed, drugs can do the most damage to a fetus during the first trimester,
a time when many women do not even know they are pregnant.
No matter the situation, birth injuries can be devastating both for the
parents and the child. Depending on the nature and severity of your child’s
injury, he may require ongoing medical care, therapy, or even housing
An Attorney Can Help
If your child’s injury was caused by the negligence of your physician
or a pharmaceutical company, they may be liable for expenses such as medical
bills, lost future earnings, pain and suffering, and more.
If your child has been injured, contact an experienced birth injury attorney.
A lawyer knowledgeable about birth injuries can assess your case and help
you get the compensation you and your child deserve. For more information,
contact an attorney today.