FDA Looking At Diabetic Foot Drug and HIV Drugs
Dow Jones

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Thursday it's conducting a safety review of Regranex, a Johnson & Johnson (JNJ) gel approved to treat diabetic foot and leg ulcers after a study suggested the product might increase the risk of cancer-related deaths.

The agency said it received information from a study that was conducted using a health insurance plan database of patients with diabetes who were at least 19 years of age and did not have a history of cancer.

The study showed patients who were prescribed Regranex three or more times had an increase in the number of cancer-related deaths compared to those not receiving the product. However, the FDA said there was not enough information to say whether there was an increase in the number of patients who developed new cancers.

"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex, " the agency said in an early communication posted on its Web site Thursday. Early communications are a recently developed tool the FDA uses to tell consumers and health-care professionals that the agency is looking into a particular safety concern, but that it hasn't reached any conclusions.

Regranex was approved in December 1997 and is form of a human platelet-derived growth factor that is applied directly to diabetic foot and leg ulcers.

The FDA said the platelet growth factor has a biologic activity like that produced naturally by the body and causes cells to divide more rapidly. Because of this, the FDA said Johnson & Johnson has been looking for any adverse side effects such as an increase in the number of cancers. The FDA said in that a separate, long-term safety study completed in 2001, there were more cancers in people who used Regranex than in those who did not use it.

The FDA said because there are risks associated with diabetic foot and leg ulcers that do not heal that patients and doctors should weigh the potential risk of using Regranex against the benefits.

Jackie Jankewicz, a spokeswoman for the J&J unit that sells Regranex, said the company is cooperating with the FDA and said the firm is "confident in the safety and effectiveness" of the product. So far about 780,000 patients have used Regranex, mostly in the U.S.

Separately, the FDA said it was also looking at HIV drugs, Ziagen, by GlaxoSmithKline (GSK), and Bristol-Myers Squibb's (BMY) Videx to see if the drugs increase the risk for heart attacks. The FDA said an analysis from a recently published study about heart attack risk is "incomplete," but is currently evaluating the "overall risks and benefits" of the drugs.

- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

  (END) Dow Jones Newswires
  03-27-08 1658ET
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