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Drugs

FDA Orders Recall of Lotronex Due to Severe Side Effects

Strategic Insights

— 1 min read

The Food and Drug Administration (FDA) has asked the manufacturer of Lotronex, a treatment for irritable bowel syndrome, to remove the drug from pharmacy shelves after dozens of patients suffered serious side effects and at least three died. The FDA cited severe constipation and ischemic colitis, a lack of blood flow to the colon, as the primary concerns. Lotronex had been on the market for less than 10 months and had been approved to help patients with chronic diarrhea.

Key Takeaways:

  • At least three patients have died, and five have suffered from severe side effects, including constipation and ischemic colitis, while taking Lotronex.
  • The FDA has ordered the manufacturer, Glaxo Wellcome, to stop selling the drug due to its severe side effects.
  • Lotronex was the first drug approved to help patients with irritable bowel syndrome, a condition affecting up to 15% of Americans.
  • The FDA had speeded its review of Lotronex due to its potential benefits but received reports of problems soon after its approval.
  • Public Citizen, a consumer group, had been calling for a recall since months ago, citing the drug's risks outweighing its potential benefits for patients with irritable bowel syndrome.
  • This is the third prescription drug recalled by the FDA this year, following Propulsid and Rezulin.
  • The FDA has been approving drugs more quickly, which has raised questions about the safety of medicines reaching patients.

Statistics:

  • 70 patients have suffered from severe side effects, including constipation and ischemic colitis, while taking Lotronex.
  • 300,000 women in the United States have tried Lotronex since its approval.
  • 15% of Americans suffer from irritable bowel syndrome, a condition affecting up to 15 million people in the United States alone.
  • 7 prescription drugs have been taken off the market since September 1997 due to safety problems, including Redux, a diet drug.
  • Since 1979, the FDA has reviewed its drug recalls and has not found a disproportionate number in recent years.
  • Lotronex had been on the market for less than 10 months before being recalled.

Sources:

  • The New York Times, March [no date provided]
  • Food and Drug Administration (FDA) press release [no date provided]
  • Glaxo Wellcome press release [no date provided]
  • Public Citizen press release [no date provided]

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