Propulsid Linked to Child Death

Propulsid is linked to child death along with its other severe side effects. It has been linked to different heart problems including heart arrhythmia and heart attack. Propulsid is manufactured by Janssen pharmaceutical, a subsidiary of Johnson and Johnson. It was approved by FDA in 1993. Even then FDA asked for labeled warning related to rare cases of increased heartbeats.
A number of children died due to cardiac arrhythmias after using Propulsid. One of such case is of 3-month-old Scott. He died due to sudden infant death syndrome as a side effect of Propulsid use, in October 1997.

A lawsuit has been filed in Pennsylvania court accusing Janssen to be liable for death of a 9-month-old boy. It also named the doctor, who administered the drug to the baby. Gage Stevens, a 9-month-old boy had reflux had been administered by the drug Propulsid within a pediatric study approved by the FDA. This study was being performed by researchers at the University of Pittsburgh. The boy died due to cardiac arrhythmia after using the medicine in 1999.
Propulsid is brand name for cisapride. It comes in both tablets and suspension. Propulsid contains Cisapride as main active ingredient. Propulsid or Cisapride is used for treatment of heartburn, which occurs due to gastric reflux. It regulates the acid level in esophagus. Cisapride increases the rate of digestion. It also increases bowel movements and strengthens the muscle between stomach and esophagus.
Doctors prescribe it for purposes not listed in medical guide too based on their clinical judgment. Use of this medicine has been restricted to U.S. market only.
Use of Propulsid could lead to many serious side effects. Some of them could be dangerous. It could cause dizziness, fainting feeling, irregular or fast heartbeat, heart attack, chest pain, mood or mental changes, pain in stomach or other stomach problems, allergic reactions, breathing trouble and feeling of passing out.

Propulsid suspension has been prescribed by at large by pediatricians to treat gastric reflux. Reflux can hinder infants’ digestion. This medicine was never proved effective or safe for infants.
The British Medicines Control Agency rejected sales of Propulsid to be continued. They even opposed restricted access scheme, as they did not deemed it fit to protect public health. The British have also warned earlier regarding any use of Propulsid in infants and children. It was opposing the idea of prescribing Propulsid to infants and children up to age 12. The use of Propulsid was restricted in U.S. only due to safety conce
s associated with it.
Many reports related to cardiac problems and death in patients, especially in infants and children attracted FDA attention to Propulsid side effects. Finally in January 2000 FDA announced about the link of Propulsid to heart arrhythmia. This led to recall of this drug by its manufacturer Johnson and Johnson very same year. But the lawsuit against side effects of Propulsid kept pouring in. Even now Johnson and Johnson, manufacturer of Propulsid, are facing numerous lawsuits related to heart related problems due to use of Propulsid.
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