Regranex Gel (becaplermin): Is It Too Risky to Use?
Posted by
Armand RossettiNovember 11, 2008 1:25 PMTags: Regranex,
cancer,
studt,
Ethicon,
Johnson & Johnson,
Ortho-McNeil,
FDA,
update,
drug warning,
labeling. insurance,
retrospective Regranex is a prescription gel that diabetic patients apply directly to foot and leg ulcers. On June 6, 2008, The Food and Drug Administration (FDA) posted a follow up communication about their ongoing review of Regranex. In that release, the FDA indicated that it had received information about a study that investigated the possibility of an increased risk of cancer in patients with diabetes who used Regranex.
Regranex is a recombinant form of human platelet-derived growth factor, and it has a biologic activity that is similar to growth factor that the body produces naturally. Since growth factors cause cells to divide more rapidly, Regranex’ manufacturer, Ortho-McNeil (Ortho), continued to monitor studies begun before the FDA approved Regranex in December 1997, for evidence of adverse effects. Ortho Diagnostics was looking for evidence of increased numbers of cancers (Ortho-McNeil is a subsidiary of Johnson & Johnson (J&J)).
The first indication of increased cancers became evident from a study completed in 2001. An additional study using a health insurance database became available in 2003. The 2003 study did not identify any single type of cancer. The increase included all types of cancers.
The retrospective 2003 study was an analysis of a database of health insurance plan patients 19 years or older, with no history of cancer who were either using Regranex or not. The study showed that among patients whose doctors had prescribed Regranex three or more times, there was an increase in the number of patients who had died of cancer. The information was not definitive enough to show whether there was an increase in the number of patients that developed new cancers.
Between March and June 2008,the FDA issued an update to the March Regranex release. The FDA stated that it had completed its review of the insurance study and that it had concluded that the risk of death from cancer in patients who used three or more tubes of Regranex was five (5) times higher than in study patients who did not use Regranex. However the risk of getting new cancers was the same as in non-users in the study, but the duration in the study was not long enough to detect new cancers. As a result, the manufacturer added a new boxed warning to the product labeling:
“When Regranex is used with good ulcer care practices (e.g. removing dead tissue, relieving pressure, controlling infection), it increases the chance of complete healing of diabetic ulcers, a type of ulcer with few other treatment options. Complications from infections of foot ulcers are one of the leading causes of hospitalization in patients with diabetes. FDA recommends that Regranex be used only when the benefits are expected to outweigh the risks described in the labeling. The updated labeling describes the information that led to the new Boxed Warning.
WARNING
An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy. (See CONTRAINDICATIONS and WARNINGS)”.
See also Ortho-McNeil Important Drug Warning, news of Johnson & Johnson’s warning, and the warning from Ethicon.
It is also evident that not treating foot and leg ulcers that result from diabetes can be very risky, leading to gangrene, eventual amputation and possibly death.
Given all of the above, my questions are...even with ulceration that might lead to amputation or death: 1) How complicated is it to successfully determine on a case-by-case basis whether the benefits outweigh the risks; 2) What is/are the alternative(s) to using Regranex; and 3) If the answer to question one is “very complicated”, and the answer to question 2 is “several safe alternatives”, then why not recall Regranex and address the cancer problem without further risking public safety?