Zelnorm Lawsuit

Zelnorm, a tegaserod maleate tablet, was approved in 2002 by the FDA and is used to treat constipated women with irritable bowel syndrome. In 2004 the approval was expanded to treat chronic constipation in both men and women younger than 65. The drug is no longer available in the U.S.

              The hydrogen maleate salt contained in Zelnorm is tegaserod.  tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. The drug’s empirical formula is C16H23N5O.C4H4O4 and the molecular weight is 417.47.

              As the maleate salt in Zelnorm, Tegaserod is a white to off-white crystalline powder and is soluble slightly in ethanol and even less soluble in water.  1.385mg of tegaserod as the maleate salt is equivalent to 1 mg of tegaserod.

              Zelnorm is available for oral use in the 2 mg and 6 mg tablets in blister packs containing 2 mg and 6 mg tegaserod and the following inactive ingredients:

·       lactose monohydrate

·       polyethylene glycol 4000

·       Crospovidone

·       glyceryl monostearate

·       hypromellose

·       poloxamer 188

Zelnorm is also available in 6mg tablets in prescription bottles containing 6mg tegaserod and the following inactive ingredients:

·       lactose monohydrate

·       colloidal silicon dioxide

·       crospovidone

·       glyceryl behenate

·       hypromellose

Zelnorm is used to treat patients less than 65 years of age with chronic idiopathic constipation and for the treatment of women with IBS. Zelnorm’s effectiveness in patients older than 65 years has not yet been established and its efficiency for treatment of IBS with constipation or chronic idiopathic constipation has not yet been studied beyond 12 weeks.

The recommended dose of Zelnorm for patients with Chronic Idiopathic Constipation is 6mg taken orally before meals twice daily. The need for continued therapy should be assessed periodically by patients and their physicians.

 

The recommended dose of Zlnorm for patients with IBS with constipation is 6mg taken orally before meals twice daily for 4 to 6 weeks. An additional 4 to 6 week course can be considered for those women who respond to therapy at the initial 4 to 6 weeks.

Zelnorm® (tegaserod maleate) is available as a marbled, whitish to slightly yellowish, circular flat tablets with a bevelled edge and should be stored at 77°F. The drug need to be protected from moisture as it is soluble.

In 2007 FDA stated that for most patients the benefits of this drug no longer outweigh the risks. This was a result of randomized trails conducted by Novartis that questioned the drugs safety. The data shows that the risk of cardiovascular adverse events associated with use of Zelnorm is higher than with placebo treatment. The FDA notified Novartis Pharmaceuticals Corporation that the company must cease its marketing of Zelnorm. The drug is no longer available in the U.S.

Some side effects and adverse events associated with the use of Zelnorm are:

·       Abdominal Pain

·       Diarrhea

·       Nausea

·       Flatulence

·       Headache

·       Dizziness

·       Migraine

·       Accidental Trauma

·       Leg Pain

·       Back Pain

·       Arthropathy

·       Abdominal distension

·       Upper Abdominal pain

·       Vomiting

·       Dizziness

·       Insomnia

·       Headache aggravated

·       Fatigue

·       Respiratory tract infection

·       Sinusitis

·       Fungal infection

·       Back Pain

·       Myalgi

·       Dysmenorrhoea

·       Pharyngitis

·       Sinus congestion

·       Urinary tract infection

·       Rash

·       Pruritus

              The following are some other events that were reported to occur during treatment with Zelnorm but not necessarily caused by it:

·       Angina pectoris

·       Supraventricular tachycardia

·       Syncope

·       Vertigo

·       Visual disturbance

·       Hemorrhoids

·       Proctalgia

·       Stomach discomfort

·       Fecal incontinence

·       Irritable bowel syndrome

·       Dspepsia

·       Gastroesophageal reflux

·       Gastritis

·       Chest pain

·       Peripheral edema

·       Cholelithiasis

·       Hypersensitivity reactions

·       Increased Creatinine phosphokinase

·       Increased eosinophil count

·       Low neutrophil count

·       Increased appetite

·       Breast carcinoma

·       Depression

·       Sleep disorder

·       Restlessness

·       Dyspnea

·       pharyngolaryngeal pain

·       Miscarriage

·       Menorrhagia

·       Cholecystectomy

·       Flushing

·       Hypotension

 

 

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