Johnson & Johnson
The company announced Friday that the Food and Drug Administration is requiring it to add a boxed warning to Regranex, saying that patients who had cancer and used three or more tubes of the gel had an increased risk of dying from cancer. The data comes from a post-marketing study in which four patients who had multiple prescriptions of Regranex died of cancer.
Clearly, the new warning will make doctors reluctant to prescribe Regranex several times to clear up a patient's recurring foot ulcer. Whether it will cause doctors to avoid the drug altogether remains to be seen. Either way, Regranex sales are small enough so that Johnson & Johnson doesn't break them out, so a decline won't likely have much of an effect on the company. That's an advantage of being large.
The very small company BioMimetic Therapeutics
It's clear from the increased number of communications about potential side effects that the FDA is taking its safety responsibilities seriously. Whether it's that using Merck's