Chronic Pain Today

FDA Approves Amitiza for IBS-C
Only drug available in United States for irritable bowel syndrome with constipation

This release contains revisions posted April 30, 2008

The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.

Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.  

“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. “This drug represents an important step in helping to provide medical relief from their symptoms.”

The safety and efficacy of Amitiza was established in two major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8 percent were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least two of the following additional symptoms: 1) fewer than 3 spontaneous bowel movements per week (that did not result from laxative use); 2) hard stools; or 3) moderate or severe straining with bowel movements.  In the studies some patients received Amitiza and others were given a placebo. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12 week treatment period than patients who received placebo. The safety of long term treatment was assessed in a study in which all patients were treated with Amitiza for a duration that ranged 9 to 13 months.

The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing), and heart palpitations.

Amitiza should be taken twice-a-day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.

Amitiza is not approved for use in children and men. It is not to be administered to patients suffering from severe diarrhea or patients with known or suspected bowel obstructions. Its safety and efficacy has not been established in patients with renal or hepatic impairment, pregnant, or nursing mothers.

Amitiza is also approved for the treatment of chronic idiopathic constipation (CIC), but the dose for that indication is higher, 24 micrograms twice a day.

Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc., Deerfield, IL.  As with all FDA-approved products, the agency will monitor Amitiza throughout its life cycle. Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

For more information about Irritable Bowel Syndrome, visit:

National Institute of Diabetes and Digestive and Kidney Diseases—Irritable Bowel Syndrome http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/

Connection to Care (Lyrica)

Company
Pfizer

Contact Information
PO Box 66585
St. Louis, MO 63166-6585
1-(800) 707-8990 (phone)

Resources:

Connection to Care Lyrica Application 

http://www.pfizerfriends.net/Lyrica/C2C.pdf

Click here to visit the program’s web site.

Eligibility:
An annual gross income of less than $19,000 for individuals and less than $31,000 for families. Applicants must not have prescription drug coverage through any public or private programs such as Medicaid, state sponsored drug assistance programs, employee, military, retirement or pension programs. Patients who have reached their caps or belong to “generics only” plans are ineligible to participate in Connection to Care.

Other Information:
THIS APPLICATION IS FOR LYRICA ONLY - For other drugs covered by Connection to Care, see the main program.

To enroll in the program, patients must submit a completed application, a copy of their most recent tax return with supporting financial information and an original prescription from their doctor.

Product(s) covered by program:
Lyrica®

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of “conventional” antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

“It is important that health care professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, M.D., director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research. “The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia.”

Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or “tics.”

Neither class of antipsychotic is FDA-approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called “off-label” use and falls within the practice of medicine.

Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

An explanation of the data and advice for treating patients is available in an FDA notice to health care professionals being issued today.

The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, under the new authority of FDAAA, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

People taking antipsychotic drugs should not abruptly stop taking them. Caregivers and patients should talk to the patient’s health care professionals about any concerns.

The medications involved in this action are:

For more information, see

FDA Information for Healthcare Professionals: Antipsychotics
http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm

FDA Historical Information on Atypical Antipsychotic Drugs
http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm

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To begin your exercise plan designed to help with your chronic pain, you will need to check with your doctor to see what is right for you. However, by starting slow you will eventually need to get up to exercising three to five times a week for half an hour to an hour each time. You will also need to incorporate flexibility exercises, strengthening exercises, and aerobic exercises in your workout.

Flexibility -Flexibility exercises includes yoga, stretches, and pilates. It will help keep you limber and mobile.

Strengthening - Strengthening exercises includes lifting weights. This will build muscle tone and improve bone condition.

Aerobic - Aerobic exercises includes biking, walking, swimming, and dancing. It will keep your circulation good, your heart healthy, and will help aid in weight loss.

Exercise That Increases Pain
Exercising without a proper warm-up or stretching beforehand.
Overdoing your exercise plan or overusing your joints.
To do any exercise that will hinder instead of help your pain condition.

Are You Overdoing Exercise?
You may be overdoing your exercise routine if you are experiencing any of the following:
Increased, or new, pain that lasts an hour past your exercise routine
Lesser range of motion than before your exercise routine
More fatigued after exercise than before it
Weaker after your exercise than before it