FDA Reviewing Potential Cancer Risk from Regranx, an Ulcer Drug
The FDA was very busy yesterday. I already mentioned about the investigation into the potential link between Singulair and suicide. Now there has been a concern raised regarding a potential risk of cancer from a topical medication used to treat ulcers on feet and legs. The drug, Regranex, is used by diabetics to address ulcers on their feet and legs. For diabetics, such ulcers are serious because if not properly cared for, they could ultimately result in amputation. However, apparently there are several studies using a health insurance database which indicate that for those who were given 3 or more prescriptions of this medication, the deaths from cancer were higher than those who were had less than 3. No particular type of cancer has been identified at this time. The FDA, along with Johnson and Johnson are going to work together to see if there is an actual link.
Look, all medications have risks. All medications have potential adverse reactions. The issue has always been whether the benefits of the drug outweigh the risks. Clearly, assuming this drug does work, the benefit i.e. saving a diabetic from losing a limb, is significant. But depending how significant the potential is to develop cancer if you use that drug, the benefit may clearly be outweighed by the risk. Again, I am happy to see the FDA being very proactive in getting the word out there. Although it appears the first study which indicated this relationship with cancer was completed in 2001.....Yes, 7 years ago. Now the FDA does indicate it is looking at additional data through June 2003 and it does take sometime to gather and evaluate data, but again, that data is almost 5 years old. When you are dealing with the potential of a drug causing cancer, you'd think the FDA and more importantly, the manufacturer of the drug would move a little quicker.
