Lotronex May Return
May 20, 2001
For many women suffering from Irritable Bowel Syndrome (IBS), the approval of Lotronex in February 2000 was a blessing. However, the drug was pulled from the market less than six months after it was approved. This was because many patients using Lotronex were diagnosed with ischemic colitis and severe constipation. In some cases, those patients required surgery or hospitalization. The drug left at least five people dead.
When the Food and Drug Administration received this information, it asked the makers of Lotronex, GlaxoSmithKline Pharmaceuticals, to voluntarily remove the drug from the market. Despite the fact that sales had already totaled $55 million and had been projected to generate more than $100 million a year, GlaxoSmithKline agreed with the FDA and pulled the drug.
Now, GlaxoSmithKline has been involved in meetings with the FDA to reintroduce Lotronex to the public. This comes after both GlaxoSmithKline and the FDA received thousands of letters from patients asking for the drug's return. The FDA continues to harbor serious concerns about the drug. In order to bring Lotronex back to the marketplace, GlaxoSmithKline may need to introduce some sort of "risk management" program to address the drug's side effects. In addition, it is not clear whether the FDA will allow the drug to be distributed freely or whether it will be given only in specific circumstances.
Spokespeople for GlaxoSmithKline are aware that if Lotronex does return to the marketplace, there will likely be restrictions on the drug's use. In an internal FDA memo, obtained and released by the consumer advocacy group Public Citizen, conversations between the FDA and GlaxoSmithKline revolved around the difficulty in implementing, monitoring, and enforcing such a risk management program.
-- Article Courtesy of InjuryBoard.com
More ...
- Public Citizen Criticizes Lotronex's Reintroduction
- GlaxoSmithKline Pledges New Restrictions if Lotronex is Reintroduced
- Some Want Lotronex Back
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