FDA Approved Fentanyl For Cancer Pain

Abstral transmucosal tablets (fentanyl) to aide in pain management for adults with cancer has now been granted U.S. Food and Drug Administration approval for immediate release. Transmucosal medications are given on the inside of the mouth, applied to the soft surfaces (inside cheek, gum, tongue, nasal passages or throat) where they dissolve quickly.

According to Dr. John Jenkins, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, this is a valuable step for patients with cancer pain to offer choices for the treatment of their breakthrough pain.

Abstral is signified for the management of advanced pain in patients with cancer that are 18 years old and older, who already use opioid pain medications constantly and who require and are able to safely high doses of an additional opioid medicine. The term breakthrough pain that comes on quickly for short time spans and is not relieved by a patient's usual pain management plan. These patients are considered opioid tolerant due to their current opioid medicine usage. Only the health care professionals which are skilled in Schedule II opioids to treat pain should prescribe this medication product.

Abstral is only available through a REMS program, which is intended to decrease the risk of misuse, addiction and overdose. This program states that pharmacies, distributors and health care professionals who prescribe this medication to outpatients are required to enroll in the programs to prescribe, dispense and distribute this medication. The FDA has a standardized key parts of the REMS program to expedite the adoption of a single shared system. These key parts include REMS document, the Patient-Prescriber Agreement and the enrollment form. These parts can be used by all sponsors of immediate release transmucosal fentanyl products to devise individual REMS programs such as the program approved for Abstral.

Dr. Jenkins states is an essential step toward decreasing the burden on the healthcare system of putting into action REMS programs. When they are totally executed, FDA expects the subscribers, pharmacies and distributors of all immediate transmucosal fentanyl products will be able to use standardized materials and a single shared system to place in use the REMS program.

The safety of this medication has been evaluated in 311 opioid tolerant cancer patients with breakthrough pain. Two hundred and seventy patients were treated in multiple dose studies which lasted from one to four hundred and five days with an average time span of 131 days and with 44 patients being treated for at least one year.

Noted common negative reactions of this medication include nausea, constipation, drowsiness, headache. There have been a few severe negative reactions which have included death and have been reported in other patients who use immediate release transmucosal fentanyl products. These deaths are stated to have occurred due to improper patient selection and/or improper dosage.

There are alternative treatments which may aide in the reduction of cancer pain:

Acupuncture

Acupuncture is used to provide relief for symptoms of cancer and cancer treatments. In some cases it has been known to provide relief from side effects like nausea, vomiting and other related symptoms.

Chiropractic

Chiropractic can be beneficial to a cancer patients overall health. By adjustments and connection of the musculoskeletal dysfunctions it can most of the times decrease the stress on the nervous system. This then restores the body's ability to heal and function more properly.

Chiropractic treatments can provide relief for pain and stiffness in the muscles and joints which are caused by intense surgery, chemotherapy and radiation. It can also decrease numerous other symptoms which include pain in back and neck, sciatic nerve pain, headaches, nausea, pain when walking and pain or numbness in hands and feet.

Naturopathic

The goal in naturopathic medicine in cancer patients is to provide support for the patients metabolism during treatments. Lessen side effects from the treatments. Aide in boosting the bodies immune system. Improve energy, well-being and overall quality of life.

Some of the therapies used consist of vitamins and minerals. Herbs that work with the body's own chemistry are gentle and have few side effects.

A few alternative practitioners in or around Detroit:

Detroit Community Acupuncture

4100 Woodward Avenue

Detroit

313-831-3222

Acupuncture & Herbs Miracle

23700 Orchard Lake Road Suite K

Farmington Hills

248-504-4989

A & L Chiropractic Center

24281 Middlebelt Road