Diabetes Gel Regranex Linked to Cancer

Regranex Users Have 5 Times More Cancer Deaths

June 6, 2008 -- Diabetes patients who use Regranex gel to treat dangerous foot and leg ulcers may have a fivefold higher risk of dying from cancer, the FDA today warned.

The FDA will ask Regranex maker Ethicon (a division of Johnson & Johnson) to put a "black box" warning label on the drug. The black-box warning is FDA's highest warning level.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," Susan Walker, MD, director of the FDA's Division of Dermatological and Dental Products, says in a news release. "Regranex is not recommended for patients with known malignancies."

The cancer finding comes from an FDA review of a postmarketing survey that suggested there might be a link between Regranex and cancer.

"FDA has now completed its review of the study and has concluded that the increase in the risk of death from cancer in patients who used three or more tubes of Regranex was five times higher than in those patients who did not use Regranex," the FDA reports.

Despite this fivefold increase in risk, the finding is based on only four excess cases of cancer, according to an Ethicon news release.

"We remain committed to the safety and efficacy of this product when used according to its label," Ethicon spokeswoman Jackie Jankewicz tells WebMD.

Regranex is a medicine that is a genetically engineered form of a human growth factor that helps wounds heal faster. It is a huge benefit to diabetic patients with slow-healing wounds on their legs or feet that often result in amputation of the affected limb.

Because Regranex makes cells grow faster, there has been concern that it will also make cancer cells grow more quickly. That's why Ethicon has monitored patients since the drug was approved in December 1997.

There's no evidence that Regranex causes new cancers, although the follow-up study has not gone on long enough to rule out this possibility.

Answer:

Your level is currently NormalHigh (hyperglycemia).Low (hypoglycemia).

If the level is below 70 and you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Your blood sugar level is slightly high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is currently normal. However, if you are concerned about diabetes speak with your physician. There may be other risk factors that increase your risk for diabetes.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Your blood sugar level may be high, depending on when you last ate. If you have not eaten for at least 8 hours, your blood sugar should be less than 100. If you've eaten within the last 2 hours, your blood sugar should be less than 140. You should call your health care provider and ask if you need laboratory tests to check for diabetes. If you are pregnant always consult with your health care provider.

Blood sugars consistently above 180 warrant prompt medical attention.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Your blood sugar level is high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. If you are pregnant always consult with your health care provider.

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