Amitiza Lawsuit

What is Amitiza?

Amitiza, which utilizes Lubiprostone, is used to relieve stomach pain, straining and bloating. The drug relieves indigestion and stomach problems by promoting the production of softer and more frequent bowel movements in women who have chronic constipation (infrequent or difficult passage of stools that last 3 months or longer). Amitiza is also prescribed to patients with irritable bowel syndrome (a medical condition that causes cramps or stomach pain, bloating and difficult or infrequent passage of stools). Amitiza belongs to a class of medications called laxatives; it is effective by increasing the amount of fluid that flows to the bowel, allowing the stool to pass more easily.

The first patent for Amitiza expired during the Spring of 2011. At this time, no generic versions are available.

Amitiza comes as a capsule that is taken orally with food twice a day (morning and evening). If you are prescribed Amitiza, you must take it as prescribed; failing to abide by the directions printed on the label or prescription will result in an increase of Amitiza side effects. Furthermore, Amitiza will only relieve your symptoms; it is not a cure.

The United States Food and Drug Administration, in 2008, approved Amitiza for the treatment of IBS in adult women aged 18 and over. This approval marked Amitiza as the only FDA-approved treatment for IBS in the United States.

The efficacy and safety of Amitiza was established in a major study involving 1,154 patients diagnosed with IBS. The majority of patients studied were women. The study revealed that patients treated with Amitiza reported that their IBS symptoms were marginally or significantly relieved over a 3 month treatment period. The efficacy of Amitiza in men was not definitely demonstrated.

Amitiza Side Effects:

Amitiza side effects may be present regardless of situation or adherence to prescription directions. Please inform your doctor if any Amitiza side effects are severe or persistent:

• Nausea

• Stomach pain or bloating

• Diarrhea is the most common Amitiza side effect

• Heartburn and headaches are common Amitiza side effects

• Swelling of the feet, ankles, hands or lower legs are classified as Amitiza side effects

• Tiredness is a Amitiza side effect

• Discomfort in the chest is a Amitiza side effect

Some Amitiza side effects may be more severe; if you experience any of the following Amitiza side effects, please call your doctor immediately:

• Shortness of breath is regarded as a severe Amitiza side effect

• Rashes are severe Amitiza side effects

• Swelling of the lips, mouth, face throat or tongue are all deemed Amitiza side effects

• Tightness in the throat is regarded as a dangerous Amitiza side effect

Other Amitiza side effects may present themselves. Please call your doctor if you experience any adverse reactions while consuming Amitiza.

If you experience insufferable Amitiza side effects, you or your medical professional may file a report with the United States Food and Drug Administration’s MedWatch Adverse Reporting program, located online at http://www.fda.gov/Safety/MedWatch or via phone at 1-800-332-1088.

Amitiza FDA Regulations:

The FDA instituted the following warnings concerning Amitiza; these warnings are found on the back of the Amitiza box:

In clinical trials conducted to study Amitiza in treatment of chronic idiopathic constipation and IBS-C there were reports of dyspnea. This was reported at 2.5% of the treated chronic idiopathic constipation population and at 0.4% in the treated IBS-C population. Although not classified as serious adverse events, some patients discontinued treatment on study because of this event. There have been postmarketing reports of dyspnea when using Amitiza 24 mcg...

...These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30-60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses.

In addition to the above warning, the FDA also lists all Amitiza side effects on the packaging.

Amitiza Lawsuits:

Amitiza lawsuits are filed by users (or user’s family members) who experience debilitating adverse reactions. An Amitiza lawsuit seeks Amitiza settlements to secure compensation for the injured user. Amitiza settlements provide compensation for the user’s medical costs, lost wages from missed work and pain and suffering.

Amitiza is currently one of the only FDA approved drugs for its specific treatment areas. Because of the drug’s effectiveness and meager side effects (rarely is a patient overcome by Amitiza side effects) there are no pending Amitiza lawsuits in the United States. That being said, if you feel victimized as a result of Amitiza-use, or if Amitiza altered your life in an irrevocable way, you should consult an experienced drug or product liability lawyer to initiate an Amitiza lawsuit. In addition to contacting these legal specialists, Amitiza lawsuits may be filed by medical malpractice lawyers. Seeking Amitiza settlements through this legal resource typically requires a claim that places negligence or fault on your prescribing medical professional.

Sources:

1. FDA Approves amitiza for IBS-C retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116889.htm

2. United States National Library of Medicine "Lubiprostone" retrieved from: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000384/

3. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm117700.htm