Foot Health and Care

Orthotic Devices and Drugs
by Food and Drug Administration (FDA)

(Page 3 of 5)

Orthotic devices are intended to make the feet more comfortable, minimize stress on the foot, or improve an abnormal or irregular walking pattern. An orthotic device could be a conservative approach to a foot problem, a preventive measure to avoid problems, or a useful support after foot surgery.

According to the American Academy of Orthopaedic Surgeons, orthotic devices commonly used include bunion shield pads, arch pads for people with a flat foot, and heel inserts for people with plantar fasciitis. These devices are sold over-the-counter at drugstores and sporting stores. They can be custom made and also sold by podiatrists, physical therapists, or orthotic companies.

Consumers might do well to try a less expensive OTC orthotic device first. "But if the problem doesn't go away after six weeks, you may need to seek a professional consultation and a custom orthotic may be indicated," says Eddy Gosschalk of Southern California Orthotics and Prosthetics. "People who are at risk for developing wounds or who have an unusual foot shape tend to need a custom orthotic." To create a custom orthotic, a plaster cast is taken of your foot and sent to a laboratory.

Most orthotic devices are considered "Class I exempt" by the FDA. This category means they are exempt from pre-market notification requirements. But they still must be manufactured under a quality assurance program, be suitable for intended use, be adequately packaged and properly labeled, and have establishment registration and device-listing forms on file with the FDA. Legally marketed Class I devices are subject to the least regulatory control because they present minimal potential for harm to the user. But when orthotic devices make a new health claim or a claim for certain treatments, or use a fundamentally different technology, they must go through FDA clearance.

Non-Prescription Drug Products

The types of OTC products for foot health include pain medicines such as nonsteroidal anti-inflammatory drugs and products that treat athlete's foot, corns, calluses, blisters, and warts.

Depending on the intended use, some OTC foot products, such as lotions for moisturizing the skin, are considered cosmetics and not drugs. There are medicated powders and creams to treat athlete's foot. For corns and calluses, there are nonmedicated pads to improve comfort when walking, as well as medicated pads and patches that work to get rid of dead skin. Similar products are used to shrink warts. These products are typically made of salicyclic acid. They should be used with care so that healthy skin isn't harmed, and they should never be used by people with diabetes or poor foot circulation.

Matthew Holman, Ph.D., a scientist in the FDA's Office of Nonprescription Products, says consumers need to pay close attention to drug labels. "Consumers should read the indications, directions, and warnings carefully," Holman says. "A product won't be effective if you are trying to treat a condition that's not in the label. If it says to only use the product on intact skin with no open sores, that's important. If a product isn't working or the condition becomes worse, you need to seek a doctor's advice." People with heart disease, diabetes, and circulation problems should never self-treat because of the risk of infection.

Prescription Drugs

Prescription drugs for treating the feet include pain medicine, antibiotics for infections, and antifungal medicine. For instance, an ingrown toenail may require antibiotic or antifungal treatment if it becomes infected. For bunions and hammertoes, a cortisone injection may be given to relieve inflammation and pain.

Fungal nails make toenails thick, brittle, and discolored to white, yellow, or brown. The fungus grows deep in the nail bed, and it won't go away on its own. It also can spread to other toenails. "Discolored nails aren't always from fungus," says Andersen. "They could also be from trauma due to exercise or psoriasis, so we take a fungal culture to make a diagnosis."

Penlac (ciclopirox), made by Dermik Laboratories of Berwyn, Pa., is an example of a topical antifungal. It is generally used daily for several months for mild to moderate nail fungus. Side effects include irritation and redness around the nails. Oral medications for fungal infections, including fungal nails and athlete's foot, are Lamisil (terbinafine) made by Novartis Pharmaceuticals of East Hanover, N.J., and Sporanox (itraconazole), made by Janssen Pharmaceuticals of Titusville, N.J. These medicines travel through the bloodstream to attack the fungus. The tablets are taken daily for about 12 weeks. It takes about nine months for a healthy nail to grow in.

The most commonly reported side effects of the oral antifungals are headaches and stomachaches. In 2001, the FDA put out a public health advisory about both drugs and announced labeling changes. Both drugs have been associated with serious liver problems resulting in liver failure and death in rare cases. The FDA and the maker of Sporanox also warned against using Sporanox for those who have a heart condition, because of safety concerns.

Patients using these drugs should immediately report symptoms of persistent nausea, anorexia, fatigue, or vomiting, upper right abdominal pain or jaundice, dark urine, or pale stools. A simple blood test is used to check liver function during treatment.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.