The side effects of Amitiza

Amitiza (lubiprostone) is marketed by Sucampo Pharmaceuticals. It was approved by the Food and Drug Administration in 2006, Amitiza is prescribed for the treatment and management of constipation. It is sold in India by Sun Pharmaceutical under the brand name of Lubowel. Ranbaxy Laboratories also sells lubiprostone in India under the brand name of Lubilax [1]. Currently, there are no generic formulations of this medication on the market [2].

Uses of Amitiza

Amitiza is prescribed to treat chronic idiopathic -- meaning cause unknown -- constipation (CIC). This is the type of constipation found in women over the age of 18 who are suffering from irritable bowel syndrome (IBS). It can also be used to treat patients who are suffering from constipation that is induced by the consumption of opioids taken for pain management. The effectiveness of this drug has not been established for individuals who are taking alternatives to opioids, such as methadone.

Treatment of children and pregnant women

Amitiza has not yet been cleared for use with children. However, clinical studies are underway to determine the safety of using it with that segment of the population. The manufacturers of Amitiza state that the safety of the drug for pregnant women has not been evaluated. Data obtained from animals suggests that a fetus could be harmed if its mother uses the drug while she is pregnant. In addition, Amitiza has been shown to cause diarrhea in infants who are nursed by women taking this medication. Women should inform their physician that they are nursing, or that they plan to do so, prior to being prescribed Amitiza. A nursing mother should also closely monitor her baby for the presence for diarrhea and inform their doctor immediately of such an occurrence [3].

How it works

Amitiza is formulated to work by prompting the body to increase the amount of fluids that it secretes into the large intestine. This, in turn, may make stimulate a bowel movement and ease off the passing of stool. If the ensuing bowel movement is complete, patients may find relief from symptoms like abdominal discomfort and bloating, reduce the urge to strain while having a bowel movement, and lessen the feeling of incomplete emptying [4].

Side effects of Amitiza

The manufacturer of Amitiza, Sucampo Pharmaceuticals, has acknowledged that taking their drug could produce serious side effects. If a patient suffers from any of the following while taking Amitiza, their physician should be notified immediately [5]:

• Stomach pain;
• Diarrhea;
• Nausea;
• Swelling of the stomach or abdominal area;
• Pressure in the full stomach or bloated feeling;
• Fever;
• Cough;
• Headache;
• Increase in sweating;
• Discomfort in the stomach or abdomen
• Chest pain;
• Blood in the stool;
• Chest discomfort;
• Black and tarry stools;
• General feeling of illness, malice or discomfort;
• Chills;
• Symptoms of a cold or the flu;
• Vomiting;
• Muscle pains and aches;
• Chest tightness;
• Sore throat;
• Runny nose;
• Loss of appetite;
• Shivering;
• Joint pain;
• Loss of bowel control;
• Weakness or tiredness that is unusual;
• Trouble sleeping;
• Shortness of breath.

The following side effects have been deemed as less common by Sucampo Pharmaceuticals. According to the literature that accompanies Amitiza, it is not necessary to seek medical attention if a person who is taking this drug experiences them. It is possible that a healthcare professional could provide that patient with ways to help ease the symptoms though:

• Change in the way things taste;
• Dizziness;
• Painful urination;
• Burning urination;
• Cold sweats;
• Belching;
• Passing gas;
• Heartburn;
• Frequently feeling the urge to urinate;
• Excess gas or air in the intestines or stomach;
• Cloudy urine;
• Bloody urine;
• Pain the lower back or in the side;
• Muscle stiffness;
• Muscle cramps;
• Tingling in the feet or hands;
• Sore throat;
• Upset stomach;
• Feeling unusually tired or drowsy;
• Swollen joints;
• Feeling sluggish or dull;

Experiences of real-life users

The experiences of users of Amitiza paint a less rosy picture of the drug's side effects than the manufacturer's literature. In many cases, it produced side effects that were so bad that patients stopped taking it. One of the most common side effects mentioned was nausea. This nausea tended to affect the patients within about 20 minutes of taking Amitiza. Some users described severe nausea that was so bad that they had episodes of dry heaving but were unable to vomit.

Another common side effect cited by numerous patients is a general feeling of unwellness and malaise that made them feel nauseous and sick all the time. Bloating and swelling were other side effects that was mentioned by numerous users. In fact, the bloating was so noticeable that some patients felt distended and looked like they were several months pregnant. Swelling has also caused symptoms that make it difficult for patients to breathe.

Sucampo Pharmaceuticals has acknowledged that some people experience shortness of breath within the first hour of taking the first does. However, according to their literature, this is a symptom that is expected to resolve itself within three hours without further intervention.

Some people have experienced this side effect again when taking additional doses of Amitiza. The shortness of breath has alarmed some patients so much that they stopped taking the medication. The patient should contact their health care professional if they experience shortness of breath when they take Amitiza [6].

Amitiza and fecal impaction

One side effect that many patients who took Amitiza repeatedly talked about was the fact that the drug makes them feel the urge to move their bowels, but that they were unable to do so. In some cases, the patient noted that they had stomach pain and cramping instead. Other patients mentioned that when they were finally able to move their bowels, their stool was hard and in the shape of a ball.

Interactions with other drugs

The manufacturer of Amitiza states that it can aversely interact with other drugs. Prior to taking this medication, it is important that patients tell their doctor about any over-the-counter and prescription medications they are taking. In addition, there are some drugs, such as methanone, that could affect the way Amitiza works as well as its effectiveness.

Patient conditions that may by impacted by Amitiza

There are a number of conditions that a health care provider should be aware of before prescribing Amitiza. For example, patients who have a compromised liver should inform their health care provider about it before taking this medication.

Because Amitiza has not been fully studied in pregnant women [7], it should only be prescribed to them if the expected benefits outweigh the potential for risk to the developing baby. An infant who is nursing could develop diarrhea if his or her mother is taking Amitiza. This situation needs to be monitored closely to ensure that the nursling's health is not suffering.

While Amitiza is designed to work to combat the constipation that is often the result of a pain management system that includes opioids, if a patient is taking an diphenylheptane opioid - also known as methadone, the healthcare professional needs to be aware of it before prescribing Amitiza.

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