LONDON (Thomson Financial) - BioMimetic Therapeutics today responded to a US
Food and Drug Administration (FDA) communication regarding its safety review of
the drug Regranex, Johnson & Johnson's topical gel for the treatment of diabetic
foot and leg ulcers.
The FDA yesterday said there there may be some evidence for increased risk
of death from cancer in patients who had repeated treatments with Regranex.
BioMimetic said that according to the communication, "posting this
information does not mean that the FDA has concluded a causal relationship
between the drug product and the emerging safety issue. Nor does it mean that
FDA is advising healthcare professionals to discontinue prescribing this
product."
In the study referenced in the FDA communication, there also appeared to be
inconsistent data, the company also said.
"One analysis indicated no elevation in risk of cancer while another
analysis suggested that among those who were prescribed Regranex three or more
times, there was an increase in the number of patients who died as a result of
cancer," it added.
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