Generic: Tegaserod maleate
Date approved: 2002
Status: Voluntarily withdrawn from market in United States upon request of the federal Food and Drug Administration (FDA)
Approved uses: Short-term treatment of chronic constipation in women with irritable bowel syndrome (IBS); treatment of chronic constipation in patients age 65 and under.
Off-Label uses: Treatment of IBS in men; treatment of idiopathic constipation in patients over 65 years of age
Zelnorm has been linked with a higher chance of stroke, heart attack and chest pain in some patients. Other Zelnorm side effects include abdominal pain, diarrhea and headache.
Zelnorm (tegaserod maleate) is a drug used in the treatment of irritable bowel syndrome (IBS) and manufactured by Novartis. It was approved for short-term treatment of constipation in IBS-affected women and for chronic constipation in patients 65 years and younger. In 2007, Zelnorm was found to cause an increased risk of stroke and heart attacks in patients and Novartis, at the urging of the federal Food and Drug Administration (FDA), withdrew Zelnorm from the market in the United States.
Novartis Recalls IBS Drug Zelnorm
It was hailed as a breakthrough treatment for irritable bowel syndrome (IBS) and constipation. Its ad campaign ran prominently on TV and in the national press. But Zelnorm, the IBS drug produced by Novartis, has been linked to serious side effects, including stroke and heart attack, and now it’s been pulled from store shelves in a voluntary recall. The Zelnorm recall took place upon the urging of the federal Food and Drug Administration (FDA), who analyzed data from nearly 30 clinical trials that showed over 18,000 patients who suffered from adverse cardiovascular events, including stroke, heart attack, and angina.
Serious Cardiovascular Side Effects of Zelnorm
Zelnorm was originally approved in 2002 for the short-term treatment of constipation in women with IBS. It was later approved for treatment of chronic constipation in patients aged 65 and under. The FDA’s data review shows that 0.11 percent of patients who take Zelnorm experience serious cardiovascular events such as stroke and heart attack, compared to only 0.01 percent of placebo patients. This news has shaken Novartis, who previously predicted that Zelnorm would rake in over $1 billion by 2011 and launched a high-visibility ad campaign featuring writing on slender, toned stomachs to tout the new drug.
Though Zelnorm was initially released to rave reviews and “breakthrough drug” predictions, the FDA round-up culminated in Novartis being asked to withdraw the drug. The FDA concluded that Zelnorm’s risks presently outweigh its potential benefits to patients, a fact that Novartis has stringently denied in press releases and interviews. Though there may be a subset of the population for whom Zelnorm is the only viable treatment, those patients will have to wait as the FDA reevaluates the safety of the drug and decides whether to allow Novartis to reintroduce it.
Novartis Denies Zelnorm Side Effects
Though Zelnorm has been linked to serious cardiovascular side effects, Novartis is denying that Zelnorm has any causal connection to these events and insists that the drug can be useful to patients with constipation and/or IBS. However, doctors and the FDA are recommending that patients discontinue use of Zelnorm immediately and speak with their doctor about alternative treatments. If you have experienced chest pain or a cardiovascular event, it is vital that you seek emergency treatment as soon as possible and inform your doctor about your use of Zelnorm. Symptoms of cardiovascular distress include chest pain, dizziness, sudden weakness, shortness of breath, or other sudden impairment.
Zelnorm was only approved for use in the two populations cited above. However, it has also been prescribed off-label for men with IBS and patients who suffer from idiopathic constipation (of unknown cause). These patients were not included in the FDA’s studies. In addition, it is estimated that only between one and ten percent of all serious drug side effects are actually reported to the FDA, so the statistics of adverse Zelnorm side effects could in fact be much higher.
If You’ve Been Affected
If you have experienced cardiovascular side effects while using Zelnorm, contact an experienced unsafe drugs attorney as soon as possible. Your Zelnorm lawyer can help determine whether you should file a Zelnorm lawsuit and/or seek compensation for expenses such as medical care, lost wages and future treatment. Looking for a confidential, quick consultation with a great Zelnorm attorney? LegalView can help connect you to a competent Zelnorm attorney. Just click on the case evaluation form at the top of this page to get started.
Zelnorm Side Effects: Know the Risks
With recent news that Zelnorm, Novartis’ “breakthrough” drug for the treatment of IBS (irritable bowel syndrome), has been taken off of store shelves due to safety concerns, you might be wondering just what risks you take when you take a Zelnorm tablet. Though manufacturer Novartis has denied the FDA’s substantial claims against Zelnorm (the result of an exhaustive analysis of nearly 30 Zelnorm studies), the risks are clear: Zelnorm has been linked to cardiovascular symptoms in roughly one percent of patients, as opposed to 0.01 percent in patients taking a placebo.
Zelnorm: Relief and Risks
Zelnorm was initially approved for the short-term treatment of constipation in women who suffer from IBS in 2002. Zelnorm has since been approved for use in IBS patients under age 65 and has been prescribed off-label to male patients suffering from IBS-related constipation and those patients who suffer from constipation of unknown origin. The drug causes nerve cells to speed the elimination of stools, effectively putting an end to constipation through the imitation of serotonin in the gut. Though Zelnorm has not been found to cure IBS (there is no current cure for irritable bowel syndrome), it was found to relieve pain, pressure and constipation in patients. Some Zelnorm side effects were already well-known before the recall: they include diarrhea, nausea, flatulence, headache, fatigue, and menstrual irregularities. But the FDA study has brought a new subset of side effects to light: “cardiovascular events” that can range from chest pain to full-on heart attack or stroke.
Cardiovascular Events in Zelnorm Patients
Some patients in the FDA studies suffered from chest pain that turned into heart attacks; others had strokes and one died of a heart attack. If you’ve taken Zelnorm, it’s important to know the signs of a heart attack or stroke: sudden onset, disorientation or dizziness, chest pain, and impaired movement or speech. Seek medical care immediately if you experience these symptoms or any other Zelnorm side effects that cause concern. Let your doctor know that you’re taking Zelnorm at the time of treatment to receive the best possible care for your condition.
Zelnorm Alternatives and Legal Options
There are other medications that treat the symptoms of IBS and lifestyle and diet changes that can help mitigate suffering for IBS patients who no longer have access to Zelnorm. However, your medical provider or gastroenterologist is the best person to prescribe the medication or lifestyle regimen that is right for you. If you have experienced cardiovascular events after taking Zelnorm, contact a medical professional immediately, then get in touch with a legal professional to discuss your legal options. You may wish to file a Zelnorm lawsuit seeking compensation for your pain and suffering, medical expenses, and/or lost wages. A good unsafe drugs attorney can help evaluate your potential Zelnorm claim and file suit. Need a referral to a Zelnorm lawyer in your area? Use our free consultation form on the upper right-hand corner of this page for a confidential, completely free case evaluation with an experienced Zelnorm attorney.