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.