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Propulsid Severe nighttime heartburn treatment drug

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Propulsid® (cisapride) is manufactured by Janssen Pharmaceutica, a wholly owned subsidiary of Johson & Johnson.  It is a treatment for severe nighttime heartburn and acid reflux disease but it is not an antacid.  An antacid works by reducing the amount of acid in the stomach; Propulsid works by preventing food and stomach acid from entering the esophagus.  This is accomplished by causing the constriction of the muscles between the esophagus and the stomach.  The drug was approved by the FDA in 1993 despite safety concerns and risks of detrimental effects on the heart.  Propulsid was removed from the United States market on July 14, 2000.

Propulsid® was removed from the market because of safety-related concerns.  However, it is estimated that 30 million Americans were exposed to Propulsid during the time that it was marketed.  According to the FDA, between 1993 and 1999, the use of cisapride was responsible for 341 reports of heart rhythm abnormalities and up to 80 deaths.  To date, Propulsid has been cited in at least 300 deaths and over 400 reports of heart rhythm abnormalities.  Heart rhythm abnormalities include irregular beating and pumping of the heart, which can be fatal if sufficiently severe.  Many children dies because the medication was not properly prescribed and parents/patients were not properly warned about the dangers of Propulsid.

A major concern with the use of Propulsid® is the fact that the medication was not widely studied in pregnant women, meaning that there was little data regarding fetal impacts at the time Propulsid was in use.  However, extrapolation from animal studies that linked harm to the fetus indicates a great potential for fetal harm.  Because of this, and the fact that cisapride has been shown to be present in breast milk, it is certain that nursing infants were exposed.  This can result in unintended harm to children.  Propulsid has also been shown to be more dangerous to the elderly.

Propulsid use may cause or exacerbate many health-related conditions and/or symptoms:

 

  • Abdominal pain or cramping
  • Abdominal or stomach bleeding
  • Blurred vision or other vision changes
  • Cardiac arrest / Heart Attack
  • Chest Pain
  • Constipation
  • Diarrhea
  • Dizziness and Disorientation
  • Drowsiness, affecting alertness
  • Dryness of mouth
  • Faintness (feeling faint)
  • Headache
  • Heart disease or irregular heart rhythm
  • Heartbeat, fast or increased rate
  • Heartburn, indigestion, and gas
  • Intestinal blockage
  • Kidney disease
  • Low potassium blood levels or
  • Lung disease
  • Nausea
  • Runny nose
  • Seizures
  • Shortness of Breath
  • Sudden Infant Death Syndrome (SIDS)
  • Swelling of the face, feet, hands, and lower legs
  • Tiredness or weakness
  • Tremor
  • Ventricular arrhythmias/tachycardia/fibrillation
  • Weight gain

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