Zelnorm Side Effects Lawsuit

Zelnorm Lawsuit

Zelnorm Side Effects 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 Lawsuit
Zelnorm Side Effects Lawsuit

              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 Lawsuit
Zelnorm Side Effects Lawsuit

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

 Zelnorm Lawsuit
Zelnorm Side Effects Lawsuit

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