ZOFRAN – BLESSING OR CURSE?

Zofran (Ondansetron developed by GlaxoSmithKline) is primarily an antiemetic (anti-nausea) prescription drug, widely used to counter the effects of post-operative and chemotherapy-induced nausea and vomiting.

Once considered rather safe by medical standards, Zofran became the 20th largest selling prescription drug in the world, earning billions of dollars for its parent company. Since Zofran was an effective antiemetic, doctors started prescribing it to pregnant women to counteract stubborn morning sickness.

That is when serious problems began to develop. Many women experience the worst symptoms of morning sickness in the first trimester – one of the most critical periods of fetal development.

If a drug or substance is going to manifest bad reactions during a pregnancy, then the initial three months of development will be the proving grounds.

MEMORIES OF THALIDOMIDE

As with the German manufactured Thalidomide during the 1950’s, this highly effective anti-nausea drug was considered quite benign and was even available overseas without a prescription. And yes, Thalidomide was extraordinarily safe – except for unborn children in their first trimester. For them, it was a teratogenic horror, mutating some of them into armless, handless or legless infants – and others born with deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness.

With Zofran, the results are not as dramatic – but the possibilities of severe birth defects are still there.

Certain studies initially indicated Zofran was found to have no negative influence on a pregnant woman’s health or the health of their unborn child. However, those initial studies were terribly wrong.

It is now known taking Zofran can lead to serious birth defects – this according to the FDA (U.S. Food and Drug Administration).

STILL OK FOR USE IN PREGNANT MOTHERS

What is hard to fathom, however, is that Zofran can still be legally prescribed to pregnant women for combatting morning sickness! Allowing a known injurious substance to be prescribed and used by pregnant women makes one wonder what in the world the FDA is thinking of.

The major deformities potentially attributed to Zofran include:

  • Heart defects
  • Musculoskeletal abnormalities
  • Deformities of the mouth
  • Jaundice (high level of blood bilirubin)

GLAXOSMITHKLINE SUED

There are currently at least two lawsuits against GlaxoSmithKline, alleging the company never engaged in clinical research to ascertain if their drug was safe for pregnant women or their developing fetuses, as well as pushing Zofran to doctors as an anti-nausea agent for morning sickness, even though it was never approved for such a use.

In 2012, GlaxoSmithKline agreed to pay a staggering three billion dollars in civil settlements for illegally marketing pharmaceutical drugs, including Zofran for use in pregnant women. Since 1991, they’ve paid out $7.56 billion in criminal and civil penalties. However, with profits approaching eight billion dollars a year, it seems these penalties and settlements are just a cost of doing business for this pharmaceutical giant.

RISKS ASSESSED

In 2011, a study initiated by the Centers for Disease Control and Prevention stated Zofran can double risks of birth defects.

Independent Danish studies monitoring over 900,000 women revealed that heart defects in infants increased by double if their moms were taking Zofran during pregnancy.

However, another Danish study of 600,000 women found little correlation between birth defects and Zofran use.

INFORMED CONSENT

If your physician does recommend Zofran for morning sickness, he or she is obligated by law to inform you fully as their patient of the possible risks involved, including risks to your unborn child.

The bottom line is this: It’s your body and your child. Are several months of morning sickness too high a price to pay for a healthy baby? When it comes to your unborn child, always choose the safest course of action.

If you have taken Zofran and your child has experienced birth defects, it is highly advisable to consult with an attorney specializing in product liability and/or medical malpractice litigation. Legal firms like Terry Bryant in Houston have been helping victims in Texas for 30 years in achieving just compensation and justice for their rightful legal claims.