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Johnson & Johnson's foot ulcer medication, Regranex, has had a U.S. Food and Drug Administration warning added to its label stating that using large amounts of the cream could increase the risk of cancer.

The warning, the FDA's strongest, states that patients who use three or more tubes of Regranex over a 20-month period of time are five times more likely to die of cancer. The black box warning advises doctors to be cautious in prescribing the medication to patients with malignancies.

In March 2008 the FDA released a warning that current data showed that there was the possibility of an increased cancer risk with the use of Regranex.

The increased warning is based on data from a retrospective study that compared cancer incidence and mortality in 1,622 patients exposed to Regranex to 2,809 similar patients that had not been exposed to the drug. The study found no increase in the incidence of cancer unless patients had been exposed to three or more tubes of the drug.

"Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it."

[Source: U.S. Food and Drug Administration]