Parker Waichman LLP

Regranex Gets New Cancer Death Warning

Regranex, a gel used to treat foot and leg ulcers in diabetics, has been linked to an increased risk of cancer death, prompting the drug’s maker to add a new black box warning to the Regranex label.  According to the  Food & Drug Administration (FDA) patients who use three or more tubes of Regranex are […]

<"https://www.yourlawyer.com/topics/overview/regranex">Regranex, a gel used to treat foot and leg ulcers in diabetics, has been linked to an increased risk of cancer death, prompting the drug’s maker to add a new black box warning to the Regranex label.  According to the  Food & Drug Administration (FDA) patients who use three or more tubes of Regranex are five times more likely to die from cancer as those not exposed to the Johnson  & Johnson drug.

Regranex was approved in 1997, and since then, has been used in more than 750,000 patients.  Regranex  is a  recombinant form of human platelet-derived growth factor that has a biologic activity that is much like that produced naturally by the body.  Growth factors have been associated with increased tumor growth, and Johnson & Johnson has been monitoring Regranex for any evidence of increased cancers or cancer deaths.

The FDA announced it was beginning a safety review of Regranex in March.  According to the FDA notice announcing the black box warning, a retrospective study which compared 1,622 patients who used Regranex to 2,809 otherwise similar patients who did not found a five-fold increase in  cancer deaths in the group exposed  to three or more tubes of Regranex.  No single type of cancer was identified, but rather deaths from all types of cancer combined were observed.   While the study found no evidence that Regranex was linked to a higher rate of new cancers,  the FDA said that the study has not gone on long enough to rule out this possibility.

The information on the retrospective study is included in the new  black box, which has been placed in the “Warnings” section of the Regranex label.  The new black box warning advises doctors to use caution when prescribing the drug to patients who have cancer.

“An increased rate of mortality secondary to malignancy was observed in patients treated with three 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,” the boxed warning states.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Thank you Parker Waichman for helping me with my case. You know what you are doing. They are very professional, I would say they are the best. Thanks to Jorge Peniche for helping me feel that I need it.
anyelo robles
4 years ago
5 Star Reviews 150
I worked with Shelly Davis for the past few years regarding my Dad’s 911 claim. My Dad passed away from being at ground zero on 911 due to cancer he developed while working in construction there. Shelly provided the quickest and most efficient information while working with me on this claim. She was quick to get back to me and was always there when I had questions. She was courteous and professional, I highly recommend using Shelly Davis from Parker Waichman.
Lauren Bertman
2 months ago
5 Star Reviews 150
Thank you Parker Waichman. Working with Christina Morace through this long process made it easy and rewarding. Always pleasant to speak with and answered any of my questions and concerns. She kept me informed on all the documents needed on a timely basis and all the updates on my case. I sincerely recommend this Law Firm for the professional and knowledgeable workers. Thank you Carrie Hargrove Erskine
Carrie Hargrove
4 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
  • (718) 469-6900
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
  • (973) 323-3603
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
  • (212) 267-6700
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
  • (631) 390-0800
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard, Suite 108
Bonita Springs, FL 34134
  • (239) 390-1000
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
  • (718) 469-6900
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
  • (516) 466-6500
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
  • (800) 968-7529