On March 30, 2007 the drug Zelnorm, used to treat Irritable Bowel Syndrome (IBS) and constipation, was pulled from the market due to serious safety concerns. The Food and Drug Administration asked Zelnorm’s manufacturer, Novartis, to pull the drug in light of new evidence that Zelnorm increases the risk of serious chest pain, heart attacks and strokes. This new evidence indicates that the risk of suffering heart-related adverse events is ten times greater for patients taking Zelnorm, compared to the general population.
If you or a loved one suffered a heart attack, stroke, or other serious injury while taking Zelnorm, you may wish to contact a qualified attorney who can evaluate your case to determine the best way to protect your legal rights. You may be entitled to compensation for your losses and suffering. Please contact our office to speak to a Zelnorm Attorney today for a free consultation.
What is Zelnorm?
Zelnorm (generic zelnorm: tegaserod maleate) is a prescription medication that was first approved in 2002 for short-term treatment of Irritable Bowel Syndrome (IBS) in women whose primary symptom is constipation. Other symptoms of IBS include cramps, bloating, abdominal pain, and diarrhea. The cause of IBS is unknown.
Later in 2004, Zelnorm was approved for the treatment of chronic constipation in women and men under the age of 65.
Zelnorm works to increase movement of stools through the bowel. In some patients, Zelnorm can relieve abdominal pain and discomfort, constipation, and bloating.
The Zelnorm Study
The study that led to the withdrawal of Zelnorm from the market was based on a Swiss government analysis of 29 studies. This meta-analysis discovered that 13 of the 11,614 patients taking Zelnorm in these studies suffered a serious adverse event such as severe chest pain, heart attack, or stroke. One of these patients died as a result of Zelnorm side effects. For comparison, just one out of 7,031 patients who took a placebo (dummy) pill suffered a non-fatal adverse event.
Cardiovascular Zelnorm Side Effects
According to this new evidence, Zelnorm can cause life-threatening cardiovascular side effects including a related Zelnorm heart attack and/or a related Zelnorm stroke. These conditions are life-threatening and require immediate medical attention.
Symptoms of a heart attack can include:
- Intermittent chest pain (angina)
- Shortness of breath
These symptoms affect 2 out of 3 patients in the few weeks prior to a heart attack.
Chest pain, which begins in the middle of the chest and may spread to the back, is a recognizable symptom of heart attack, though it is not present in all patients. Approximately one-third of heart attack suffers do not experience chest pain prior to heart attack. Women appear less likely than men to experience heart attack symptoms. People over 75 and people who have suffered heart failure, stroke, or diabetes are also less likely to present with symptoms.
Other symptoms of heart attack may include:
- Feeling Faint
- Heavy sweating that comes on suddenly
- and heart pounding
If you or a loved one experience these or other unusual symptoms while taking Zelnorm, you should seek medical attention immediately.
Symptoms of stroke depend on the location of the bleeding or blockage in the brain. Early symptoms of a stroke can include:
- sudden paralysis, loss or reduced sensation, and/or weakness to one side body (usually the face and leg)
- sudden trouble with or loss of vision
- difficulty speaking or understanding speech
- loss of balance and/or coordination
- severe headache
If you experience these symptoms, it is important to seek immediate medical attention.
Other serious Zelnorm Side Effects
In addition to serious cardiovascular risks, Zelnorm is associated with other serious side effects. For many years, Zelnorm has been known to increase the risk of serious gastrointestinal complications including:
- severe diarrhea,
- ischemic colitis,
- and other forms of intestinal ischemia.
Since the approval of Zelnorm in 2002, the FDA has received 21 reports of patients suffering serious diarrhea caused by Zelnorm, 20 reports of ischemic colitis, and 3 patients diagnosed with other forms of intestinal ischemia.
Severe diarrhea can cause low blood pressure, dehydration, and fainting, which can require hospitalization. Ischemic colitis and other types of intestinal ischemia are serious conditions whereby the blood supply to the intestines or the colon is cut off or highly restricted. These conditions, which are functionally similar to heart attacks, are potentially fatal because they lead to serious damage or death of intestinal tissues. In some cases, these conditions lead to serious complications that require surgery. Symptoms of these conditions include:
- Sudden mild to severe abdominal pain
- An urgent need for a bowel movement
- Forceful and frequent bowel movements
- Abdominal distention and/or tenderness
- Bloody stool and/or rectal bleeding
- Low back pain
In light of these symptoms, the FDA had previously added a black box warning to Zelnorm to communicate to patients and doctors about these serious risks.
If you experience any of these symptoms while taking Zelnorm, it is crucial to contact your health care provider. If you or a loved one has suffered this serious Zelnorm injury you may be able to seek compensation for your losses with the help of a caring and competent Zelnorm lawyer.
The FDA’s reaction to Zelnorm Risks
In light of this information, the FDA has determined that the risks associated with taking Zelnorm outweigh the potential benefits of using this drug. The agency urges patients who are experiencing usual symptoms while using Zelnorm to seek immediate medical care. Patients who are using Zelnorm are also urged to speak with their doctor regarding a switch to a safer medication.
The FDA has noted that, in the future, Zelnorm may be available on a restricted basis for certain patients. Through a special program, Zelnorm may become available to patients for whom the benefits might outweigh the drugs serious risks. Such patients include those whose doctors have concluded that their disease will not respond to any other treatment except Zelnorm.
Novatis still maintains that Zelnorm carries unique benefits. The company argues that there is still no conclusive evidence that proves Zelnorm causes heart attacks and strokes. Despite these contentions, the manufacturer complied with the FDA order to issue a Zelnorm recall.
Have you been harmed by Zelnorm?
If you or a loved one has suffered a serious injury while taking this drug, you may be eligible to receive compensation for your losses and suffering by filing a Zelnorm lawsuit. Please contact our qualified and experienced Zelnorm attorneys today to learn more about your legal rights and options.