Australian health authorities have removed a medicine Zelmac for irritable bowel syndrome (IBS) from sale because of safety concerns.
The drug tegaserod maleate, marketed under the name Zelmac, was taken off the market in the United States a few days ago.
The US Food and Drug Administration found that people who took the drug tegaserod maleate or Zelmac had a higher incidence of heart attack and stroke.
The manufacturer of the drug Novartis says most of the patients who had a heart attack or stroke already had cardiovascular disease or risk factors. The company Novartis says that patients with unused supplies of the drug can return them to their pharmacist for a refund.
The Therapeutic Goods Administration included Zelmac tablets, containing tegaserod maleate 6 mg, on its register on 22_January 2002 for the treatment of IBS in women whose main symptoms are constipation and abdominal pain.
Irritable bowel syndrome (IBS) is one of the most common ailments of thebowel (intestines) and affects an estimated 15% of persons in the US. The term, irritable bowel, is not a particularly good one since it implies that the bowelis responding irritably to normal stimuli, and this may or may not be the case. The several names for IBS, including spastic colon, spastic colitis, and mucouscolitis, attest to the difficulty of getting a descriptive handle on theailment. Moreover, each of the other names is itself as problematic as the term IBS.