FDA Looking At Diabetic Foot Drug and HIV Drugs
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
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
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
(END) Dow Jones Newswires