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Zelnorm was a prescription medication doctors prescribed for short-term treatment for women over 65 years of age with irritable bowel syndrome (IBS) and constipation (IBS-C). They also gave it to patients of all ages who had chronic constipation.

On March 30, 2007, the U.S. Food and Drug Administration (FDA) requested that Novartis Pharmaceuticals stop marketing Zelnorm (tegaserod maleate). The FDA made this decision after a new study found a higher chance of heart attack, stroke, and chest pain in patients taking Zelnorm.

Novartis discontinued the drug but rereleased it in 2019. However, as of 2022, it was no longer available due to business reasons.

This page will provide an overview of Zelnorm, its dangers, and the pharmaceutical company's discontinuation of the drug. It will also discuss legal options for people who became sick after using this drug.

What Conditions Did Zelnorm Treat?

Doctors used Zelnorm to help women who suffered from severe constipation and irritable bowel syndrome (IBS). Zelnorm was a serotoninergic neurogenetic modulator that increased serotonin levels in the large and small intestines.

This drug worked by speeding up the movement of the patient's stools through the bowels. Quicker bowel movements helped reduce diarrhea and constipation.

FDA Warnings to Zelnorm Patients

While the drug was still on the market, the FDA warned Zelnorm patients about several health risks associated with the drug. They urged patients to contact their healthcare providers to discuss other treatments.

Some of the health issues the FDA warned about included:

  • Severe chest pain
  • Shortness of breath
  • Ischemic colitis
  • Bloating
  • Suicidal thoughts and behavior
  • Dizziness
  • Severe diarrhea or bloody diarrhea
  • Acute abdominal pain
  • Sudden onset of weakness
  • Rectal bleeding
  • Difficulty walking or talking
  • Angina
  • Heart attack and other cardiovascular risks
  • Transient ischemic attack (mini-stroke)​

In addition to these severe health conditions, there were other possible side effects of Zelnorm. The FDA warned patients to see their doctor if they experienced worsening symptoms and side effects.

There were patients for whom no other treatment options were available and for whom the benefits of Zelnorm outweighed the risks of serious side effects. FDA tried to work with Novartis to offer Zelnorm for those patients through a particular program with a medication guide. The matter is moot since the drug company removed the drug from the market.

Who Should Not Take Zelnorm?

The FDA and other experts warned certain patients against taking Zelnorm. People with underlying conditions were at an increased risk of developing severe health issues after taking the drug.

People with the following risk factors should avoid taking Zelnorm and similar drugs:

  • High blood pressure
  • Kidney disease
  • Prior cardiovascular events
  • Liver problems
  • Gallbladder issues
  • Intestinal blockage
  • History of high cholesterol
  • Obesity
  • Sphincter of Oddi issues​

As with any other drug, seek medical advice before starting any prescription medication. Tell your doctor about any medicines, over-the-counter drugs, or supplements you are taking. This is to help avoid any adverse drug interactions.

Legal Rights for Patients Who Suffer an Injury From Prescription Drugs

All medications have potential side effects. Drug manufacturers must make their products as reasonably safe as possible by using methods such as clinical trials. They must also inform the medical community and the public of known risks associated with their drugs.

If a manufacturer fails to do so, the courts may hold them legally responsible for patient injuries. Patients who suffer an injury due to inadequate warnings or the unreasonably dangerous nature of a drug can sue under product liability.

When your product liability attorney files your lawsuit, they'll demand specific damages. Types of damages you may receive include the following:

  • Medical bills and future medical expenses
  • Lost wages and lost future income
  • Pain and suffering
  • Punitive damages

The courts rarely award punitive damages in product liability cases. They reserve these damages for cases where the defendant's behavior was egregious or intentional.

Zelnorm - Getting Legal Help

If you or a loved one experienced dangerous symptoms or health issues after unusual medical conditions while using Zelnorm, contact your doctor or other healthcare professional. You can learn more about an attorney's role in a pharmaceutical liability case here

You may also wish to meet with an experienced local product liability attorney to discuss your case. They can explain your legal rights.

If you're a health professional with information about Zelnorm, you can file a report with the FDA by calling 1-800-FDA-1088.

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