Tyner Law Firm, P.A.

History and Background

Propulsid is a prescription drug produced by Janssen Pharmaceutical, Inc., of Titusville, N.J., a subsidiary of Johnson & Johnson. It is also known under the names Prepulsid (in Canada) and more commonly as Cisapride. Propulsid was primarily prescribed for patients with severe nighttime heartburn due to gastro-esophageal reflux disease (GERD), a problem that causes stomach acid to back up into the esophagus. This sometimes occurs due to a weakened valve or sphincter that separates the esophagus and the stomach. The backup of acid creates a burning sensation in the chest, which is commonly referred to as “heartburn.” Propulsid helps move food through the stomach, thereby reducing exposure of the esophagus to stomach acid and preventing acid and food particles from washing back into the esophagus.

Side Effects & Signals:

Ų      Difficulty breathing, shortness         of breath
Ų      Cardiac arrhythmia
Ų      Cardiac arrest
Ų      Ventricular tachycardia (Fast        heartbeat)
Ų       Ventricular Fibrillation
Ų      Torsades de Pointes (TdP)
Ų       Brachycardia (Slow or              Irregular Heartbeat)
Ų       Sudden cardiac arrhythmia             death
Ų       QT Prolongation

Legal Issues Surrounding Propulsid

Recent evidence has shown that Propulsid can cause serious cardiac arrhythmia and death from heart failure when taken alone. That risk is amplified when Propulsid is taken with certain other medications. From 1993 to 1998 there were 38 reports of death in the United States involving the combination of Propulsid with other medications. These deaths were due to serious cardiac arrhythmias, including but not limited to ventricular tachycardia and ventricular fibrillation. The US Food and Drug Administration (FDA) has stated that more than 381 cases of heart rhythm abnormalities and over 80 deaths associated with the use of Propulsid have been reported as of March 24, 2000. It is estimated that these numbers represent only 10% of the actual number of deaths and occurrences. The warnings on the label of the drug increased five times since the entry of the drug in the market. Each time the label changed, Janssen revealed a little more about potential heart damage and added additional drugs that were contraindicated.

It is projected that 350,000 Americans took the drug in 1999. Over 30 million prescriptions were written to over 10 million people since Propulsid came to the market in 1993.

DRUG INTERACTIONS WITH PROPULSID

Anti-Depressants

Amitriptyline (Elavil)

Nefazodone (Serzone)
Maprotiline (Ludiomil)

Anti-Fungals

Fluconazole (Diflucan)

Itraconazole (Sporanax)
Ketoconazole (Nizoral)
Sluconazole

Antihisimines

Astemizole (Hismanal)

Anti-Psychotic Medications

Sertindole

Blood Pressure Medications

Bepridil (Vascor)

Anti-Arrhythmics

Procainamide (Procan SR, Procanbid, Pronestyl)
Quinidine (Quinidex, Quinaglute)
Sotalol

Diuretics

Furosemide
Thiazides

Heart Medications

Procaininamide (Procan SR, Procanbid, Pronestyl)
Quinidine (Quinidex, Quinaglute)

Macrolide Antibiotics

Clarithromycin (Biaxin)
Erythromycin (Ery-Tab, E.E.S., E-Mycin)
Troleandomycin (TAO)
Sparfloxacin (Zagan)

Protease Inhibitors (AIDS drugs)

Indinavir (Crixivan)
Ritonavir (Norvir)

Other Agents

Grapefruit juice
Lithium
Levodopa
Medicines for Parkinson’s Disease
Octreotide
Ranifide
Ritonavire
Sparfloxacin
Tetracycline
Troleandomycin

Medical Explanation of Propulsid’s Effect on the Heart

Propulsid, when taken alone and especially when taken with one of the drugs that is contraindicated, can cause increases in the QT intervals and lead to prolonged QT syndrome. A QT interval is the measurement of space between heartbeats. A prolonged QT interval on an electrocardiogram (ECG) illustrates a disturbance in the heart’s normal rhythm and shows that there may be a problem with conduction of electrical impulses through the heart. This can be an indicator of more serious conditions in the future, such as complete heart failure and ventricular fibrillation. If your clients have taken Propulsid and have not had an ECG done, they should be tested as soon as possible.

Propulsid and Children

Even though Propulsid was only approved for use with adults, prescriptions were routinely written for infants, especially premature babies. One Canadian study of over 58,000 babies from seventy-one different hospitals revealed that nearly (20%) twenty percent had received Propulsid. Of the 81 Propulsid-related deaths reported to the FDA since 1993, eleven were children and infants who had been given the drug. Additionally, 20 children suffered heart rhythm disturbances and other complications. Many experts believe that these children were given doses that were too high. They also advised, however, that these children and infants should have been given an ECG before being prescribed the drug.