Your Health Matters
By Claudia Parks, R.N.

FDAActs to Ensure Thyroid Drugs Don't Lose Potency Before Expiration Date. This headline of a recent news release certainly got my attention- especially, since I have three known family members, plus many friends who take this medication. The U.S. Food and Drug Administration is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life.

This action is being taken in response to concerns that the potency of the drug may deteriorate prior to its expiration date. The change will help improve the quality of the products so that consumers receive the level of medication needed to treat their thyroid disorders. Over 13 million patients use levothyroxine sodium products.

FDA is mandating that levothyroxine sodium products tighten their potency specifications to meet a 95 percent to 105 percent potency specification until their expiration date. The shelf life is the length of time drug can be stored before it degrades to unacceptable levels. Manufacturers and marketers have two years to comply with the revised specification.

Consumers can also help maintain the potency of their medications by storing medications in a dry place at room temperature and avoiding humid, hot environments such as bathrooms, which speed deterioration. Also by keeping the lid on tight.

Some strengths or package types, such as blister packs, degrade more rapidly than others, resulting in varying expiration dates within product lines. In addition, there is variability in expiration dating periods between products from different manufacturers.

A healthy, functioning thyroid gland is critical to regulating a person's overall metabolic function, which consequently impacts a host of other bodily functions. "These medicines are vital to people taking thyroid replacement or suppression therapies," said Janet Woodcock, M.D., deputy commissioner and chief medical officer and acting director of FDA's Center for Drug Evaluation and Research.

Levothyroxine sodium products have been marketed for decades in the United States. This class of drugs is used to treat hypothyroidism, as a thyroid replacement therapy, to suppress the growth of benign goiters and thyroid cancer, and as an adjunct to surgery and radioiodine therapy designed to manage some types of thyroid tumors. For more information: http://www.fda.gov/cder/drug/inf opage/levothyroxine/default.htm

The thyroid gland is in front of the throat, below the Adam's apple and just above the breastbone. It is U-shaped, each end of the U flaring back into a lobe that is about the size of the big toe. The thyroid's hormonal production stimulates or affects almost every important body process, including the body's use of oxygen. Too much or too little of the hormone, called thyroxine, can cause serious health problems.

Hypothyroidism occurs when the thyroid gland produces insufficient amounts of thyroid hormone, thereby slowing all metabolic processes in the body. Symptoms depend on the degree of thyroid deficiency and may develop slowly over many years.

SOME SYMPTOMS MAY BE: Fatigue, lethargy; intolerance to cold; unusual weight gain; constipation; dry, thickened, flaky skin; muscle cramps and weakness; deepened voice; puffiness around the eyes; dry, brittle hair or hair loss; impaired mental faculties.

Risk of hypothyroidism is greater in women over the age of 50. Patient history and physical examination are needed. Blood tests are taken to determine levels of thyroid hormone. Treatment for hypothyroidism will often be a lifelong hormone replacement therapy with the thyroid hormone (thyroxine). Always talk with your doctor if you have questions about your symptoms.

Claudia Parks, RN, is a former doctor's office and emergency room nurse and retired as an educator from Fulton County Schools. She writes Your Health Matters as a public service; the information here is designed to help you make informed choices about your health. It is not intended as a substitute for the advice of your physician. Claudia and her husband now live in the north Georgia Mountains, near Blairsville. Claudia can be reached at YHM@windstream. net