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Over time, diabetes can lead to heart and blood vessel disease, blindness, kidney failure, and foot ulcers, among other conditions. FDA regulates many products to treat these conditions.
Heart disease is the leading cause of death for people with diabetes. Three out of four diabetes-related deaths are caused by heart and blood vessel (cardiovascular) disease. People with diabetes are 2-4 times more likely to have heart disease than persons without diabetes. Even people with type 2 diabetes who do not have heart disease have an increased risk of having a heart attack. People with diabetes also tend to have other risk factors for heart disease including obesity, high blood pressure, and hardening of the arteries (atherosclerosis). In recent years, FDA has approved drugs that lower blood pressure and reduce the risk of heart attacks and strokes. It has also approved lipid-altering drugs that target abnormalities of cholesterol and triglycerides. For more information about diabetes and heart disease, use the following links:
Adults with diabetes should have yearly eye exams to ensure the health of their eyes and to protect their vision. Over time, high blood sugar levels can damage the blood vessels that feed the retina of the eye. In nonproliferative diabetic retinopathy (NPDR), an early stage of diabetic eye disease, the blood vessels may leak fluid. This may cause the retina to swell and vision to blur, a condition called diabetic macular edema. In advanced or proliferative diabetic retinopathy (PDR), abnormal new blood vessels grow on the surface of the retina. The abnormal blood vessels don't supply the retina with normal blood flow. In addition, they may eventually pull on the retina and cause it to detach. Some cases of diabetic retinopathy can be treated with laser surgery. In this procedure, doctors aim a strong beam of light onto the patient's retina to shrink or seal leaking or abnormal vessels. Laser surgery can't restore vision already lost, so early detection is important. In some advanced cases of PDR, a surgeon may remove the vitreous portion of the eye and replace it with a clear solution (called a vitrectomy). For more information about the diagnosis and treatment of diabetic eye disease, use the following links:
Over time, high blood sugar levels can damage the kidneys. Even when drugs and diet are able to control diabetes, the disease can lead to kidney disease (diabetic nephropathy) and kidney failure. Healthy kidneys act like filters to clean the blood of waste products and extra fluid. Damaged kidneys do not clean the blood well. Instead, waste products and fluid build up in the blood. People with kidney failure must either have dialysis treatment (to substitute for some of the filtering functions of the kidneys) or receive a kidney transplant. FDA regulates dialysis equipment. The agency does not inspect dialysis clinics--that is the responsibility of each state health department--but FDA approves the equipment used in dialysis. Recently, the agency has begun requiring that hemodialyzer filters and tubes be tested and approved in realistic clinical situations. For example, in about eight out of 10 hemodialysis treatments, the equipment is reused to cut costs, although it was originally tested, labeled and approved for one-time use only. FDA is now requiring manufacturers to prove that filters and tubes are safe and effective when reused. FDA is also taking a closer look at water purifying equipment used in dialysis. Pure water is crucial to hemodialysis, since impurities can kill a patient. FDA has recently begun enforcing regulations that require the manufacturers of water purifiers to prove their devices are safe and effective. For more information about the diagnosis and treatment of kidney failure, use the following links:
Adults with diabetes need to take special care of their feet. People with diabetes are at risk for foot injuries due to numbness caused by nerve damage (diabetic neuropathy) and low blood flow to the legs and feet. The most serious injury is a foot ulcer. Diabetic foot ulcers are at very high risk of becoming infected, and sometimes they cannot be healed. Non-healing foot ulcers are a frequent cause of amputation in people with diabetes. Patients with foot ulcers may use wound dressings, skin substitutes, or other treatments to protect and heal their skin. Wound dressings are medical devices that are used to protect ulcerated skin and assist in its healing. They can range from simple bandages that you can buy in the drug store to complex materials that contain antibacterial and antiviral substances. Skin substitutes are products that help in closing the wounds of slow healing ulcers in patients with diabetes. They are made from human cells known as fibroblasts that are placed on a dissolvable mesh material. When the mesh material is placed on the ulcer, it is gradually absorbed and the human cells grow and replace the damaged tissue in the ulcer. FDA has cleared one gel product (becaplermin) that is used as a treatment for diabetic foot ulcers. This product contains genetically engineered platelet-derived growth factor, one of the proteins the body produces to encourage new tissue growth. Clinical studies of the product indicated that the likelihood of complete ulcer closure, after up to 20 weeks of treatment, was greater when becaplermin is used. FDA has consumer information about several new types of treatments for diabetic foot ulcers. For information about each of these products, use the following links:
For more information about foot care for people with diabetes, use the following links:
Updated 5/21/02
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