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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.
Complications of Diabetes
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Heart and Blood Vessel Disease
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Blindness
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Kidney Failure
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Foot Ulcers
Complications of Diabetes
Heart and Blood Vessel Disease
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.
Blindness
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).
Kidney Failure
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.
Foot Ulcers
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.
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