What are some important things I should know about Lotronex?
Lotronex – How Does It Work?
While the precise mechanism of action of Lotronex was never fully understood, one hypothesis was that Lotronex blocks the action of serotonin at 5-HT3 receptor sites in the enteric nervous system, thus slowing colonic transit time and preventing IBS diarrhea-predominant symptoms. In other words, Lotronex somehow affected the action of serotonin (a neurotransmitter found in abundance in the gut), thus preventing painful cramps and slowing colon contractions to reduce diarrhea.
Lotronex Side Effects
While clinical trials of the drug showed few side effects, reports of serious and even deadly adverse reactions to the medication began cropping up shortly after its FDA approval. In some patients the drug caused side effects so severe they resulted in hospitalization and even death.
Through the end of the year 2000, sixty-three patients taking Lotronex developed ischemic colitis, an interruption of the blood supply to the large intestine which results in severe internal damage. Seventy-five patients experienced severe constipation. Most of the patients who developed these problems required hospitalization. In all, the FDA has on record 141 cases of severe gastrointestinal complications in patients who took the drug, and five deaths. As a result of these problems, Lotronex was pulled from the US market in just nine months after it debuted.
Lotronex Action Group
In response, a group of IBS patients who had experienced great success with Lotronex formed the Lotronex Action Group, a non-profit patient group seeking renewed access to the drug. The Lotronex Action Group believes Lotronex to be safe if dispensed properly, and that the benefits of Lotronex far outweigh the potential risk for adverse side effects. The LAG has urged the FDA not to lose sight of the patients, and to realize that the medical community has been slow to recognize IBS as a legitimate disorder that can have debilitating side affects.
The LAG wanted taken into account their concerns that efforts for reintroduction of the only effective treatment for some IBS patients suffering from severe diarrhea and abdominal pain will be derailed due to a lack of understanding of the severity of the symptoms IBS can cause. The LAG also maintained that although claims have been made that severe side effects have been linked to Lotronex, it appears that less than a fraction of 1% of the 300,000 people taking the drug were affected.
Moreover, the LAG contended that no data has been released proving that those who suffered from side effects were ever properly diagnosed with IBS and were also good candidates for Lotronex in the first place. The Lotronex Action Group lobbied the FDA for immediate re-release of Lotronex while avenues for continued marketing were explored between the manufacturer, GlaxoSmithKline, and the Food and Drug Administration.
In response to the pressure from both the pharmaceutical industry and the Lotronex Action Group, the FDA announced June 7, 2002 the approval of a supplemental New Drug Application (sNDA) that allows severely restricted marketing of Lotronex, to treat only women with severe diarrhea-predominant irritable bowel syndrome (IBS). The approved sNDA for Lotronex includes a risk management program to ensure patients and physicians are fully informed of risks and possible benefits of Lotronex.