Harm Caused by Labor Induction Drugs

1. frequent accidents caused by labor-inducing drugs

In Japan, labor-inducing drugs such as oxytocin and prostaglandin E₂ have been used for planned deliveries in cases where the mother or fetus has some problems, in high-risk deliveries, or to avoid delivery at nighttime or on holidays when it is difficult for medical institutions to provide emergency care. However, since around the 1970s, many maternal deaths and uterine ruptures due to labor-inducing drugs have been reported.

Labor-inducing drugs are essentially useful drugs that can avoid problems related to childbirth if used safely and in accordance with the appropriate dosage and administration as stated in the package insert, and with attention to side effects. Accidents caused by labor-inducing drugs are often due to the way the drugs are used rather than their side effects, such as easy or inappropriate use of labor-inducing drugs, too fast administration, or inadequate monitoring of delivery. This is because physicians used to not pay as much attention to drug inserts as they do now, and they used to prescribe labor-inducing drugs at their discretion. In addition, because the use of labor-inducing drugs allowed doctors to earn fees for medical examinations, there was a profit-driven practice of administering labor-inducing drugs under the name “weak labor” even when they were unnecessary.

In response to a number of accidents involving labor-inducing drugs in the 1970s, since 1974 the “Japan Association for the Protection of Motherhood” has distributed a booklet to obstetricians and gynecologists throughout Japan to warn them against the use of uterine contractions (labor-inducing drugs). The booklet cautions that the effectiveness of labor-inducing drugs varies greatly from person to person and, in rare cases, can have serious effects on mother and child. The booklet was published annually, but in the 1970s and 1980s there was a rash of accidents involving labor-inducing drugs. Despite its knowledge of these accidents and the possibility that they might occur, the former Ministry of Health and Welfare did not revise the accompanying information on dosage and precautions for the use of labor-inducing drugs until 1992, when a victims’ group demanded that it do so.

(2) Establishment of victims’ organizations

Although there have been no class action lawsuits against companies or the government for damages caused by labor-inducing drugs, there have been many medical lawsuits filed against doctors and medical institutions for each case of damage. In 1988, the “Association for the Study of Damage Caused by Induced Labor Induced Drugs” was established, led by victims, in order to identify such individual cases and to lobby the government.

In 1992, the Association for the Study of Damage Caused by Induced Labor Induced Drugs began calling on the former Ministry of Health and Welfare (MHW) to revise the package inserts of labor-induced drugs. However, the situation has not changed, and the “Association for Harm Caused by Induced Labor Induced Drugs” has continued to appeal for the revision of the package inserts for labor-inducing drugs. Currently, we are requesting that “intracerebral hemorrhage” and “premature separation of the normal placenta” be added to the package insert regarding the side effects of labor-inducing drugs.

3. seeking clarification of the actual damage

The actual number of cases of damage caused by labor-inducing drugs is difficult to ascertain because they are medical accidents that occur at individual medical institutions. According to the Association for the Study of Induced Labor Damage, nearly 400 cases of labor-inducing drugs have been reported, but these cases are considered to be just the tip of the iceberg.

The Obstetric Care Guarantee System, which began in 2009, is an important initiative for understanding the damage caused by labor-inducing drugs. Through this system, we are working to analyze cases of children who have suffered severe cerebral palsy as a result of obstetric accidents. In all of these cases, it was found that the maximum dosage of labor-inducing drugs was significantly out of the range of the revised package insert. Although accidents caused by labor-inducing drugs are still occurring today, since the proper use of such drugs is now thoroughly enforced in the package inserts, etc., inadequate delivery monitoring or the use of similar drugs in combination are often regarded as improper use and are not covered by the Adverse Reactions Relief System for Drugs.

In recent years, “painless delivery,” in which anesthesia is used to make labor less painful, has been on the rise. Because “painless delivery” involves the use of labor-inducing drugs, the use of labor-inducing drugs is also on the rise.

Currently, the “Guidelines for the Practice of Obstetrics and Gynecology” prepared by the Japanese Society of Obstetrics and Gynecology and the Japanese Society of Obstetricians and Gynecologists describe the criteria for the use of labor-inducing drugs, and their use is required in accordance with these guidelines.

References

1. Foundation for Regulatory Science of Pharmaceuticals and Medical Devices, 2012, “Lessons Learned from Drug Injury: Voices from Victims Hoping for the Prevention of Recurrence,” Yakuji Nippo Co.
2. Japan Association for Public Publications, 2011, “Knowledge of Drug Hazards You Should Know–To Prevent Health Damage Caused by Drugs,” Jiho.