Observations

FDA Consumer, May-June, 2006 by Raymond Formanek, Jr.

It's only about the size of a walnut, but if it becomes enlarged, inflamed--or worse--a man's prostate gland can be the source of enormous discomfort and worry,

The prostate's main function is to produce semen, the fluid that helps to nourish and transport sperm. Located just below a man's bladder, the prostate surrounds the urethra, a tube that carries urine from the bladder, and semen during sexual climax.

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), prostate problems afflict young and old alike. For men younger than 50, inflammation of the prostate, called prostatitis, is the most common problem.

For men older than 50, it's prostate enlargement, called benign prostatic hyperplasia, or BPH for short. Experts at the Mayo Clinic in Rochester, Minn., say that prostate gland enlargement affects about half of men in their 60s and up to 90 percent of men in their 70s and 80s. Older men also are at risk for prostate cancer, a much rarer condition.

For more on the prostate and the importance of having regular prostate examinations, see our cover story titled "Prostate Health: What Every Man Needs to Know."

About 25 cents of each dollar spent by consumers in the United States involve products regulated by the FDA. Occasionally, a company discovers a problem or a potential problem with one of those products.

One way to deal with the situation is for the manufacturer to initiate a product recall in cooperation with the FDA. While recalling a product that has been widely distributed can pose significant challenges, compared to legal actions, a voluntary recall often can be the best method to handle a problem with a product.

The FDA handles recalls for all the products it regulates--human drugs; devices and radiation-emitting products; biologics such as vaccines and blood products; veterinary products, which include animal drugs and animal feed; cosmetics; and about 80 percent of the foods consumed in the United States. To learn more about recalls, see our feature story titled "The FDA and Product Recalls."

People with Restless Legs Syndrome (RLS) often feel an overwhelming urge to move their legs in an attempt to get temporary relief from the crawling, pins and needles, prickly, or painful sensations they experience. The National Institute for Neurological Disorders and Stroke says that RLS is a common neurological disorder for which there is no cure. Read more about RLS, and the only FDA-approved drug to treat it, in our feature story titled "Treating Restless Syndrome."

We also take a look at a new FDA effort designed to ensure the safety of medical devices, a new health initiative by three HHS agencies aimed at improving cancer treatments, and advice on how to keep up with the latest drug warnings using FDA resources.

Raymond Formanek Jr.

Editor