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Ruling in Risperdal case does not affect Taiwan users: official

2012/04/12 18:26:35

Taipei, April 12 (CNA) Taiwan's Department of Health said Thursday that local patients using the drug Risperdal would not be affected by a ruling in the United States that fined Johnson & Johnson and a subsidiary, the drug's manufacturer, for improperly marketing the drug and downplaying its potential health risks.

The maker of the antipsychotic drug was punished for marketing fraud but not for manufacturing a defective drug, so the ruling does not affect patients using the drug in Taiwan, and there should be no concern, said Tai Hsueh-yung, an official with the department's Food and Drug Administration.

Moreover, the U.S. Food and Drug Administration did not issue a drug alert because of the ruling, Tai said, adding that the case centered on a suit by Medicaid regulators in the state of Arkansas over the company's marketing tactics.

The Arkansas court a day earlier ordered the U.S.-based company and its subsidiary, Janssen Pharmaceuticals, Inc., to pay more than US$1.1 billion in penalties for violating the state's Medicaid fraud laws and statutes on deceptive trade practices by claiming Risperdal to be safer than other drugs.

Under the ruling, the two have to pay US$5,000 for each of the 250,000 Risperdal prescriptions issued to the state's Medicaid patients from November 2002 through June 2006, which brings the total to more than US$1.1 billion.

Arkansas filed a lawsuit in 2007, accusing Johnson & Johnson and its Janssen unit of misleading doctors throughout the state by sending out a letter in 2003 that downplayed Risperdal's potential health hazards, which include weight gain, onset of diabetes and an increased risk of strokes, especially in the elderly.

In response, the Janssen unit said it had acted responsibly and would appeal if its motion for a new trial is denied.

(By Chen Ching-fang and Scully Hsiao)