The Hidden Dangers in the Delivery Room: Understanding Off-Label Drug Use in Childbirth

The birth of a child should be one of the most joyous moments in a parent’s life. Expectant mothers in Champaign-Urbana and across Illinois place immense trust in their doctors and medical staff to ensure a safe delivery. However, what happens when that trust is broken by the use of medications in a way that was never approved, leading to devastating birth injuries? This practice, known as “off-label” drug use, is a serious concern, and if you or your child has been harmed, a Champaign-Urbana personal injury lawyer can help you understand your rights.

At Holder Law Group, we have seen the tragic consequences of medical negligence. We believe in empowering our clients with knowledge. This post will shed light on the risks associated with off-label drug use during childbirth and what you can do if the unthinkable happens.

What is “Off-Label” Drug Use?

When the U.S. Food and Drug Administration (FDA) approves a drug, it is for a specific purpose, at a specific dosage, and for a specific patient population. This approval is based on rigorous clinical trials to prove the drug is both safe and effective for that intended use. The official information and instructions for the medication are detailed in its “label.”

“Off-label” use occurs when a doctor prescribes a medication for a condition, at a dosage, or to a patient group not covered in the drug’s approved label. While the practice is legal and sometimes beneficial in other areas of medicine, it carries significant risks, especially in the delicate environment of labor and delivery. The FDA provides clear information for patients to understand the distinction between approved and unapproved uses.

Common Off-Label Drugs in Childbirth and Their Risks

In obstetrics, certain drugs are sometimes used off-label to induce or speed up labor. While the goal may be to manage the delivery process, the potential for harm to both mother and child is substantial.

One of the most notable examples is Cytotec (generic name Misoprostol).

• Approved Use: Cytotec is an ulcer medication.
• Off-Label Use: It is used to soften the cervix and induce labor contractions.
• The Danger: The manufacturer and the FDA have issued warnings against its use in pregnant women due to a high risk of uterine hyperstimulation (excessively strong or frequent contractions), uterine rupture, amniotic fluid embolism, and severe harm or death to the baby.

Another commonly used drug is Pitocin (a synthetic form of oxytocin).

• Approved Use: Pitocin is approved to induce or augment labor in specific medical situations.
• Off-Label Danger: When used improperly or at an excessive dosage to speed up a normal labor, it can cause the same uterine hyperstimulation seen with Cytotec. This can lead to:
  • Fetal distress from lack of oxygen
  • Low heart rate in the baby
  • Uterine rupture
  • The need for an emergency C-section

Potential Consequences of Off-Label Drug Misuse

The misuse of labor-inducing drugs can lead to life-altering birth injuries. As experienced medical malpractice attorneys in Champaign-Urbana, we have handled cases involving these tragic outcomes.

Risks to the Infant:

• Cerebral Palsy
• Hypoxic-Ischemic Encephalopathy (HIE), a type of brain damage from oxygen deprivation
• Seizures
• Developmental delays
• Stillbirth

Risks to the Mother:

• Uterine rupture, which can lead to life-threatening hemorrhage
• Emergency hysterectomy, resulting in the inability to have more children
• Severe blood loss
• Death

The American College of Obstetricians and Gynecologists (ACOG) provides clinical guidance for its members, but when individual practitioners deviate from the standard of care and a patient is harmed, it can constitute medical negligence.

What To Do if You Suspect a Birth Injury

If your child suffered a birth injury and you suspect that off-label drug use or other forms of medical negligence were involved, it is crucial to act.

1. Focus on Medical Care: Your first priority is the health of your child and the mother. Seek opinions from specialists and ensure you have a clear understanding of the long-term prognosis.
2. Document Everything: Keep detailed records of all medical treatments, conversations with doctors, and timelines of events.
3. Do Not Blame Yourself: Childbirth injuries are rarely the fault of the parents. Medical professionals have a duty to inform you of the risks and obtain your informed consent.
4. Contact an Experienced Attorney: A birth injury lawyer can investigate your case, consult with medical experts, and determine if the standard of care was breached.

Holder Law Group: Your Advocates in Central Illinois

At Holder Law Group, we understand the complexities of medical malpractice law. We are dedicated to holding negligent medical professionals accountable and securing the compensation your family needs to cover a lifetime of care for an injured child.

If you believe you have a case, please contact us today for a free, confidential consultation. There is no fee unless we win your case. Let our family help yours.