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Tipranavir Warning Issued by FDA Explained Further
  "HIV Drug Tied to Eight Deaths Draws an Added FDA Warning"
Wall Street Journal
July 3, 2006
WASHINGTON -- The Food and Drug Administration and Boehringer Ingelheim Pharmaceuticals say 13 patients taking the company's Aptivus (tipranavir) HIV drug had bleeding in the brain, and eight of them died.
The FDA and the company said there were 14 events of bleeding in 13 patients who were among 6,840 HIV-infected people participating in clinical studies of the drug. Aptivus was granted conditional approval last year to treat HIV in combination with Abbott Laboratories' Norvir.
The FDA posted a statement and a "Dear Health-care Professional" letter from the company on its Web site Friday.
Boehringer Ingelheim Pharmaceuticals, a unit of Germany's Boehringer Ingelheim GmbH, added the warning on the fatal and nonfatal bleeding episodes to the drug's black-box label. That label already warned of liver failure and some deaths in patients. A black box is the strictest FDA warning a drug can carry.
Boehringer Ingelheim said in a statement that it "is confident about the benefit of Aptivus...for patients within its labeled indication."
The FDA and the company said that further investigation is ongoing but that many patients who experienced an intracranial hemorrhage had other medical conditions including head trauma and recent neurosurgery. Many patients were also on other medications, including anticoagulants and antiplatelet agents, which may have played a role in the hemorrhages.
Separately, the FDA granted the first tentative approval for a three-ingredient tablet to treat HIV infection in adults.
The drug, by Aurobindo Pharma Ltd. of Hyderabad, India, and will be sold in 15 developing countries as part of a U.S. government program to make less expensive HIV drugs available to poor nations. The tablet can't be approved for use in the U.S. because of existing patents, but the FDA said Friday that it meets all of the agency's manufacturing quality and clinical safety and efficacy standards required for marketing in the U.S.
The product contains active ingredients in widely used antiretroviral drugs Epivir, Retrovir and Viramine. GlaxoSmithKline PLC makes Epivir and Retrovir; Boehringer Ingelheim makes Viramine.
Health and Human Services Secretary Michael Leavitt said the approval "marks a significant step forward in our commitment to clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries," noting that a combination tablet simplifies treatment of HIV.
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