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Lotronex entered the market in February 2000 as a treatment for women with irritable bowel syndrome (IBS). However, while clinical trials revealed ischemic colitis, a potentially-fatal bowel disorder, as a side effect, the FDA still approved the medication generically known as alosetron hydrochloride.
Side Effects
One of the more evident side effects in clinical trials, ischemic colitis reduces blood flow to the point of causing intestinal damage. Even non-fatal cases may require surgery.
During trials, patients given Lotronex also experienced severe constipation resulting in hospital stays or surgery.
Out of the test group and, eventually, patients prescribed Lotronex, 1 in 2,000 people went through ischemic colitis and 1 in 1,000 had severe constipation.
Recalls
GlaxoSmithKline first recalled Lotronex nine months after approval. During that period, the manufacturer received three warnings, and was required by the FDA to add an updated cautionary label and provide patients with a medication guide.
At the time of recall, the FDA had record of 66 reported ischemic colitis cases and 61 of severe constipation. Out of this group, there were four possibly related deaths, and others became permanently disabled.
However, Lotronex came back into the market in 2002, when the FDA approved it with the Supplemental New Drug Application. Prescription, this time around, had more restrictions: Only specialists could recommend it to women with severe IBS.
As well, a risk management program provided physicians and patients with more comprehensive resources regarding side effects and benefits. The program requires all patients prescribed Lotronex to sign a contract stating the patient understands all risks.
Nevertheless, the risk management program has resulted in confusion and has allegedly opened manufacturer Prometheus Laboratories to more legal liabilities. As of May 2013, the company that purchased Lotronex from GlaxoSmithKline in 2007 filed a Citizen Petition criticizing the FDA’s implementation of Risk Evaluation Mitigation Strategies (REMS) – particularly that it’s unprecedented, unclear, has no standardization or agreed-upon process, and exposes them to antitrust issues.
Lawsuits
Class action lawsuits began almost immediately after the first recall in 2011. If you experienced Lotronex’s life-threatening side effects, lawyers such as Trantolo & Trantolo’s team have been managing and directing cases. To be eligible, plaintiffs for current cases must have been prescribed it between 1999 and 2000 or more recently without an REMS contract.
