Cyotec was approved by the FDA on March 17, 1999 to help prevent gastric ulcers in patients taking anti-inflammatory drugs, such as aspirin, for arthritis pain. However, many obstetricians have also been prescribing Cyotec off-label as a labor-inducing drug.
Since Cyotec was not intended to be used for this purpose, many women and children suffered from a variety of birth-related injuries as a result.
Cyotec Side Effects
The manufacturer of Cyotec, G.D. Searle & Co., never conducted clinical trials in order to determine Cyotec’s safety when given to pregnant women, as the drug was never intended for this purpose. In fact, Searle never marketed the drug for any purpose other than as an anti-ulcer prescription.
In the end, off-label Cyotec use put pregnant women and their babies at an unnecessary risk of severe, and often life-threatening, side effects.
- Increased incidence of jaundice
- Fetal distress caused by uterine hyper stimulation
- Fluid overload from the IV use
- Increased blood loss postpartum
- Amniotic fluid embolism
- Uterine rupture
- Increased risk of instrumental or surgical delivery
- Birth defects
Mothers who had previously undergone a cesarean section were at a higher risk of dangerous side effects, such as uterus ruptures, birth injuries and death of the mother and/or child.
In August 2011, Searle sent a drug alert to physicians warning of Cyotec risks and indicating that the drug should not be used to induce labor. Shortly after, the FDA issued a Safety Alert which reiterated the risks outlined in Searle’s letter.
Physicians have an obligation to provide quality healthcare while ensuring the safety of their patients. If they prescribed a drug for unapproved purposes, doctors should be held accountable for putting patients at risk. Through a medical malpractice lawsuit, Cyotec victims may be able to recover losses such as medical expenses, pain and suffering, or wrongful death benefits related to their experience.