What is Propulsid?

What does the FDA now say about the drug?

What types of cardiac problems have been reported?

Did all users of Propulsid experience problems?

Is Propulsid used for children?

Are some people at higher risk than others?

Is Propulsid still in use?

What legal recourse do Propulsid users have, if any?

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What does the FDA now say about the drug? 
The FDA has advised doctors about new warnings of cardiac problems associated with Propulsid. They have told Janssen to revise the label to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before prescribing Propulsid. Five times between the date the drug was approved and January 2000, the labeling for the drug was made progressively stronger, warning about life threatening reactions to use of the drug.

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What types of cardiac problems have been reported? 
Propulsid was found to cause heart rhythm abnormalities, resulting in various other medical problems and sometimes death. Patients with no history of cardiac problems were subjected to new difficulties that were caused either by a combination of the drug with antibiotic and antifungal drugs, or through a combination of illnesses. Some of the effects of Propulsid in adults include:

• Sudden cardiac death
• Heart attack
• Irregular heartbeat
• QT interval prolongation

And in children:

• Antinuclear antibody
• Positive anemia
• Haemolytic anemia
• Hypo-glycemia
• Confusion
• Impaired concentration
• Depression
• Apathy
• Visual changes
• Amnesia

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Is Propulsid used for children? 
The approval of Propulsid by the FDA had been only for adult use. A study of approximately 58,000 premature babies showed that about 20 percent of mothers had been given Propulsid. Presently, approximately 11 infant deaths have been associated with Propulsid use. Many doctors used Propulsid to treat babies with heartburn-causing ''gastroesophageal reflux.'' This reflux occurs when stomach acid backs up in the esophagus. Adults call that burning feeling heartburn. Babies react by vomiting. Nearly all babies do that and it is a normal occurrence because the esophagus and stomach are immature at infancy. Ninety-five percent of babies will outgrow the problem by their first birthday, and many are not treated for the condition. However, when the reflux is bad enough that babies become malnourished and don't gain weight, have trouble breathing while vomiting, or the esophageal irritation causes obvious pain, they are treated.

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Are some people at higher risk than others?
Yes. Patients at higher risk included those who were using conflicting drugs, or who had conflicting disorders such as a history of cardiac problems. Patients who used the drug alone, with no alternative therapy or conditions, generally suffered no adverse effects.

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Is Propulsid still in use? 
After years of escalating fatalities and pressure from the FDA, Janssen announced that it would voluntarily stop marketing Propulsid in the United States beginning July 14, 2000. The drug is still used for treatment. However, patients must now meet an even more stringent level of criteria. Physicians must assess each patient and then confirm that there is no alternative therapy, there is no history of cardiac problems, the patient is not taking any conflicting drugs, and the patient took an electrocardiogram and blood tests.

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What legal recourse do Propulsid users have, if any? 
If Propulsid has caused you or a loved one significant physical damage, you may be entitled to compensation. Contact us at Younce & Vtipil to evaluate your rights. It will cost you nothing to speak with an attorney about your potential claim and there is no obligation when you call.

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