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ZELNORM® (tegaserod) Notice of Withdrawal from Market


Jeffrey Roberts
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Jeffrey Roberts

ZELNORM® (tegaserod) Notice of Withdrawal from Market

Alfasigma US, Inc.

Jun 30, 2022, 08:00 ET

COVINGTON, La., June 30, 2022 /PRNewswire/ -- Alfasigma USA, Inc. announces the withdrawal of the NDA for ZELNORM® (tegaserod) effective June 30th. Alfasigma USA, Inc. will no longer make the product available in the US marketplace.  

Please know that this decision was not made lightly nor was it based on product efficacy, safety or because of an imposed recall. Our decision to remove ZELNORM® (tegaserod) from the market is strictly a business decision.

Patients will continue to have access to ZELNORM® (tegaserod) for as long as the existing supply of product remains in the trade channel. Alfasigma USA, Inc. urges patients and Health Care Providers to discuss alternative therapies that will meet patient needs.  

Important Safety Information
ZELNORM® ® IMPORTANT SAFETY INFORMATION (ISI)

Indication
ZELNORM® (tegaserod) is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).

Warnings and Precautions

Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular Events (MACE): Stroke, MI, and cardiovascular death have been reported in adults taking ZELNORM® who had an increased risk of developing an adverse cardiovascular event based on their medical history. 
Female patients less than 65 years of age should be assessed for a history of cardiovascular disease and cardiovascular risk factors prior to treatment with ZELNORM® (R). 
Discontinue ZELNORM® (R) in patients who experience an MI, stroke, TIA, or angina. Evaluate the risks and benefits of continued use of ZELNORM® (R) in patients who develop evidence of cardiovascular ischemic heart disease (e.g., coronary artery disease) and/or experience changes in health status that could increase cardiovascular risk during treatment with ZELNORM® (R).

Ischemic Colitis: Ischemic colitis and other forms of intestinal ischemia have been reported postmarketing in patients receiving ZELNORM® (R). Discontinue ZELNORM® (R) in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.

Volume Depletion Associated with Diarrhea: In postmarketing experience, serious consequences of diarrhea including hypovolemia, hypotension, and syncope have been reported in patients treated with ZELNORM® (R). Avoid use of ZELNORM® (R) in patients who are currently experiencing or frequently experience diarrhea. Instruct patients to discontinue ZELNORM® (R) and contact their healthcare provider if severe diarrhea, hypotension, or syncope occur.

Suicidal Ideation and Behavior: Monitor all ZELNORM® (R)-treated patients for clinical worsening of depression and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment. Counsel family members and caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Instruct patients to immediately discontinue ZELNORM® (R) and contact their healthcare provider if their depression is persistently worse or they are experiencing emergent suicidal thoughts or behaviors.

Common Adverse Reactions (incidence >2% and greater than placebo) 
The most common adverse reactions in 3 placebo-controlled trials of ZELNORM® (R) in female IBS-C patients less than 65 years of age: headache (14% vs 10% placebo), abdominal pain (11% vs 10%), nausea (8% vs 7%), diarrhea (8% vs 3%), flatulence (6% vs 5%), dyspepsia (4% vs 3%), and dizziness (4% vs 3%).

Use in Specific Populations

  • Pregnancy: Safety and effectiveness not established
  • Lactation: Breastfeeding not recommended
  • Pediatric use: Safety and effectiveness not established
  • Geriatric use: Not indicated for patients 65 years of age and older
  • Severe renal conditions: Contraindicated
  • Moderate to severe hepatic conditions: Contraindicated

For more information, please see the Medication Guide and full Prescribing Information for ZELNORM® (R) at www.ZELNORM® (R)us.com.  

In order to assist Alfasigma USA, Inc. in monitoring safety, we encourage all healthcare professionals to report any adverse events to Alfasigma USA, Inc. at 1-844-639-9726 or to the FDA at 1-800-FDA-1088 or online at http://www.fda.gov/Safety/MedWatch/ .

If you have any additional questions, please contact Alfasigma USA, Inc. Medical Information at 1-844-639-9726 between the hours of 8:00 a.m. and 5:00 p.m. EST.

About Alfasigma USA, Inc.

Alfasigma USA, Inc. is the American affiliate of Alfasigma, a leading Italian pharmaceutical company. Alfasigma is present in more than 90 countries, with a workforce of around 3,000 people and 5 manufacturing plants. Alfasigma USA, Inc. distributes a portfolio of prescription nutritional products to help individuals who are suffering from GI disorders (VSL#3®) (ZELNORM®), major depressive disorder (DEPLIN®), diabetic peripheral neuropathy (METANX®), and mild cognitive impairment (CerefolinNAC®). Alfasigma USA, Inc. is building on their commitment to making 'Pharmaceuticals with Passion' in the US. For more information, please visit www.alfasigmausa.com or email info@alfasigma.com.

Media Contact:
Morrow Creative
Angel Morrow
Vice President, New Media
amorrow@brucemorrowcreative.com 
On behalf of Alfasigma USA, Inc.

SOURCE Alfasigma USA, Inc.

Source: https://www.prnewswire.com/news-releases/zelnorm-tegaserod-notice-of-withdrawal-from-market-301578099.html


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Any idea what happened?  Man, this has been such a godsend, and now gone, again.  I wonder if it's available in any other country.

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I found out about this from my Doctor a few days ago. He told my they were not making any money. He also said that there was way too many restrictions on who can even get a prescription for Zelnorm. I told him that the price was really high and they stopped providing a coupon a while ago. He is not sure if another company will buy it, but at this point I am guessing the answer is No.  His suggestion is to see if your pharmacy can get some and keep it for you until you can fill it. My concern is it will be their waiting for someone else but it may be worth trying.  He also said to look out of the country. So far I have not found anything, but it might be worth contacting a place directly.  I will keep looking, and I plan to transfer my prescription around town if need be until I can't find it.

This is hard to process. Many of us have been down this road before. I just hope there is better news ahead.

 

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Jeffrey Roberts

Alfasigma had the rights to market the drug in the US; however, the drug is actually owned by USWorldMeds. They acquired it from Novartis. Not sure what the marketing rights are; however, since the FDA re-approved it, perhaps USWorldMeds will find another pharma which could buy the rights from Alfasigma and market it even if they are making little money. This is what happened with Lotronex an IBS-D medication.

It's very sad that Alfasigma put their profits ahead of the value that it brings to IBS-C patients. Sadly, there are no other 5-HT4 medications approved for IBS-C and CIC; however Motegrity (prucalopride) could be something your doctor could consider off-label as it is also a 5-HT4 medication like Zelnorm and is approved for CIC. There is no data to say whether it works the same as Zelnorm, ie: does it help pain + constipation.

If you can afford it, I would try and get your pharmacy to order as much as they can get so that you continue to have access to it for some time before the distributors run out of it.

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Thank you for all of the info. So is it safe to say that there would not be anything available in other countries like there was back in 2007? So far I have tried a Canadian Pharmacy that my Doctor told me about and there isn't any listed on the website. I will call them tomorrow.  The last place I got it in 2019 before it came back to the U.S. doesn't have it either. 

At this point, I'll chase it for a while and then give Motegrity a try.  

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Jeffrey Roberts

Unfortunately Zelnorm is no longer marketed anywhere in the world. Canada withdrew it in 2007.

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