The lawyers at our firm are currently investigating potential lawsuits on behalf of people who were injured following treatment with Regranex. Regranex is a topical medication used by diabetics to treat foot and leg ulcers. In June 2008, the Food & Drug Administration (FDA) announced the addition of a black box warning – the agency’s most urgent safety warning – to the Regranex label because patients who used the gel were at a higher risk of dying from cancer. Our Regranex side effect lawyers are offering free consultations to anyone injured as a result of treatment with this drug.
Regranex, manufactured by Johnson & Johnson, was approved by the Food & Drug Administration (FDA) in 1997. Regranex speeds the cure of foot and leg ulcers, open sores that either do not improve or are slow to heal, in diabetic patients. Without proper treatment, the sores can lead to complications that require lower-leg amputations. Since it came on the market, Regranex has been used by more than 750,000 patients.
The Regranex side effect lawyers at our firm believe that the formulation of this drug makes it more likely that frequent use may lead to increased cancer deaths. 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 cause cells to divide more rapidly, and they have been associated with tumor growth. For that reason, Regranex is contraindicated for use in people with a history of skin cancer.
Since it was first marketed, Johnson & Johnson has continued to monitor studies begun before Regranex was approved for any evidence of adverse effects such as increased numbers of cancers or cancer deaths. The FDA announced in March 2008 that it was reviewing the safety of Regranex after two studies indicated that it put patients at higher risk of cancer death. The first, a long term safety study completed in 2001, indicated there were more cancers in people who used Regranex than in those who did not use it.
Following the report of the study completed in 2001, an additional Regranex study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not.
The second Regranex study, released in 2008, found an increase in the number of cancer deaths among patients who had been prescribed Regranex three or more times. No single type of cancer was identified, but rather deaths from all types of cancer combined were observed. Those findings prompted the FDA to announce it was taking a closer look at the study, and the agency began its Regranex safety review.
Regranex Black Box Warning
The FDA review of the study, which compared 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed, confirmed the risk of cancer death. The FDA said it found a five-fold increased risk of cancer deaths in the group exposed to three or more tubes of Regranex. While the study found no evidence that Regranex was linked to a higher rate of new cancers, the follow-up study has not gone on long enough to rule out this possibility.
Those findings prompted the FDA to announce the new Regranex black box warning. The information on the retrospective study is included in the 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.
“In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex,” Susan Walker, MD, director of the FDA’s Division of Dermatological and Dental Products, said in a statement. “Regranex is not recommended for patients with known malignancies.”
Legal Help for Victims of Regranex Side Effects
Our Regranex side effect lawyers believe Johnson & Johnson should have done more to warn users about the dangers associated with this drug. Growth factors are known to be associated with accelerated tumor growth, so the risk was evident even prior to the publication of the above mentioned Regranex studies. At the very least, Johnson & Johnson should have warned of the increased cancer death risk following the publication of the first study showing this link.
If you or a loved one suffered serious side effects following treatment with Regranex, you may have valuable legal rights. Please fill out our online form or call our office at 1-800-YOURLAWYER (1-800-968-7529) to speak to one of our Regranex injury lawyers about your case.