Lotronex is the brand name of a medication that doctors prescribe for some female patients to treat Irritable Bowel Syndrome (IBS). It comes in the form of a pill. It is prescribed specifically for those patients whose main symptom is diarrhea. In addition, it would be prescribed for patients whose IBS symptoms have continued for 6 months or more and who have not obtained relief after using other available treatments.
It is important to know that some people who have used Lotronex experienced serious side effects while taking the drug, including the following:
- Constipation with serious complications such as a ruptured colon;
- Reduced blood flow to the large intestine.
These symptoms can develop very quickly. The person who suffers from them may be admitted to the hospital. The symptoms can lead to blood transfusions, surgery, and death, although this does not happen often. Still, it is a possibility in rare cases.
What Is the History of Lotronex?
Lotronex was granted a patent in 1987 and introduced to the market for use by patients with a doctor’s prescription. The federal Food and Drug Administration took it off the market in 2000 because its investigators discovered that Lotronex could reduce blood flow to the colon. This, in turn, could lead to a medical condition known as “ischemic colitis,” which can be fatal.
In research regarding the negative side effects of Lotronex, the incidence of ischaemic colitis was 2 in 1000 users of the medication. The incidence of severe complications of constipation related to Lotronex, e.g., obstruction, perforation, other complications, and death, was 1 in 1000.
An FDA medical officer reviewed the research. It showed that 27% of patients who took Lotronex experienced constipation. In one trial, constipation occurred in 30% of the subjects who took Lotronex but only in 3% of patients in the placebo group. The researchers reported that many patients dropped out of the study because of constipation.
Nonetheless, Lotronex returned to the market in 2002 because of demand from doctors and patients. This demand was based on the fact that it is an effective treatment for the particular symptoms suffered by some women. But it now comes with enhanced warnings and restrictions on its use.
Patients who take Lotronex are advised to read the Medication Guide that comes with the prescription every time it is refilled. Also, patients are directed to call their doctor immediately if they have certain symptoms, e.g., constipation. They should also call their doctor if their constipation does not improve after they have stopped taking Lotronex.
Prometheus Laboratories Inc. currently markets Lotronex.
Who Should Not Take Lotronex?
The prescribing information brochure for Lotronex says that people with constipation or a history of chronic or severe constipation should not use the medication. Also, people with any of the following conditions in their medical history should not use Lotronex:
- Intestinal obstruction,
- Stricture, or narrowing, of the intestinal tract;
- Toxic megacolon, which is an abnormal dilation of the colon;
- Perforation of the intestinal tract;
- Adhesions in the intestinal tract;
- Reduced blood flow to a part of the large intestine;
- Impaired circulation of the intestine;
- Blood clots, usually in the legs;
- Blood clotting disorder that makes a person more likely to develop blood clots;
- Inflammatory bowel disease;
- Inflammation and ulcers of the colon,
- Diverticulitis, which is the inflammation of abnormal pouches, called “diverticula,” that develop in the wall of the large intestine;
- Severe impairment of the liver so that it cannot perform its basic functions;
- A person should not take the drug fluvoxamine, brand name Luvox, an antidepressant, at the same time as taking Lotronex.
What Should I Do If I Have Been Injured by Lotronex?
If a person believes they have suffered a significant injury because they have taken Lotronex, they will consult a personal injury lawyer. The person may be able to seek damages for the economic loss caused by their injury and their pain and suffering.
Depending on the facts of the case, the person may have a claim for medical malpractice. For example, this claim would be possible if a doctor prescribed Lotronex for a patient with one or more of the conditions listed above. These conditions indicate that a person probably should not take Lotronex. So, if a doctor prescribes the medication for them, it might be a medical error for the doctor.
Another possible claim would be a claim for pharmacy error. For example, if a pharmacist has a complete record of all of a person’s medications and should recognize that a person should not take Lotronex, but fills a prescription for the medication anyways, then this might be a pharmacy error. This could be the basis for a civil lawsuit for damages.
Still another possible claim would be a claim for strict product liability. The strict product liability law makes manufacturers and distributors liable for the harm caused by product defects. A person injured by a defect in a product does not have to prove that negligence on the part of the manufacturers or distributors led to the defect. Rather, an injured person only has to prove that the product was defective somehow, and because of the defect, the person was injured.
Defects in products usually fall into one of three types as follows:
- Warning Defects: A warning defect might be present in a case involving a medication such as Lotronex. If a product presents risks of harm to a user, the manufacturer and distributors must warn consumers about those risks. So, if a person were to suffer an injury from using Lotronex that is not addressed in the warnings for the product, the person would be able to recover damages for that warning defect;
- Manufacturing Defects: These are defects that arise during the manufacturing process for a product. For example, some of the materials used to make a product might contain a flaw or imperfection, resulting in a defect. Or, a chemical used to make some potion or medication might be old and degraded. Or a manufacturer might use the wrong ingredient. Again, if a product injures a person with a manufacturing defect, they should be able to recover damages;
- Design Defects: These are defects that originate during the design phase of a product. Again, if the defect causes a product to injure a consumer, the consumer can recover damages.
An injured person seeks compensatory damages in a lawsuit for negligence or strict product liability. The damages should reimburse the person for their economic and non-economic losses, such as lost income, the cost of medical treatment, and pain and suffering.
Do I Need the Help of a Lawyer for My Lotronex Issue?
If you have suffered serious health issues that you believe are related to your taking Lotronex, you should consult a class action lawyer in your area.
Your lawyer can enlist a medical expert to review your case’s facts and determine whether taking Lotronex may have caused your health issues. If your legal team determines that Lotronex is the cause of your injuries, your lawyer can help you protect your legal rights and get compensation for your injuries. They can also guide you through the legal process from start to finish and answer any questions you may have along the way.
