Somerville, NJ (June 6, 2008) -- ETHICON, INC. today announces revised labeling for REGRANEX Gel, a topical formulation of recombinant human platelet-derived growth factor indicated as an adjunct to the treatment of lower extremity diabetic neuropathic ulcers.
The WARNINGS section of the label has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for it. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to REGRANEX Gel to 2,809 matched comparators. The results were consistent with no overall increase in cancer incidence among patients exposed to REGRANEX Gel, however, there was a five- fold increased risk of cancer mortality in the group exposed to three or more tubes of REGRANEX Gel, based on four cases. The types of cancers varied and were remote from the treatment site.
The BOXED WARNING states "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 Company has worked closely with the FDA to ensure that the REGRANEX Gel label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions. ETHICON, INC. is committed to broadly disseminating this new prescribing information about the safety of REGRANEX Gel through a "Dear Healthcare Professional" letter and its field-based employees.
"We remain confident in the safety and efficacy of REGRANEX Gel when used according to its label," said James C. Hart, MD, Vice President, Global Medical Affairs, ETHICON. "The benefits of REGRANEX Gel have been established in well-controlled studies and confirmed in clinical practice."
REGRANEX Gel, manufactured by OMJ Pharmaceuticals, Inc. for its distributor Ortho-McNeil, is commercialized in the United States by Johnson & Johnson Wound Management, a division of ETHICON, INC.
About REGRANEX Gel
REGRANEX Gel is the only FDA-approved prescription medicine that contains platelet-derived growth factor (PDGF), a substance that helps the body heal. It is applied directly to the ulcer. REGRANEX Gel, in conjunction with good wound care, has been proven to help heal diabetic ulcers more effectively than standard wound care. The product has been on the market for ten years and has been used to treat more than 750,000 patients.
Important Safety Information
REGRANEX Gel is contraindicated in patients with neoplasms at the site of application. An increased risk of mortality secondary to malignancy remote from the site of treatment has been observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. (See Boxed WARNING). However, in a separate analysis of cancer incidence, these results were consistent with no overall increase in cancer incidence (See WARNINGS). REGRANEX Gel should be used with caution in patients with known malignancy. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of this product (eg, parabens). Erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo gel. REGRANEX Gel should not be used in wounds that close by primary intention.
Please visit www.Regranex.com for the full Prescribing Information.
(C) ETHICON, INC. 2008 REGRANEX Gel is a registered trademark of Ortho-McNeil TM, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc.
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Somerville, NJ (June 6, 2008) -- ETHICON, INC. today announces revised labeling for REGRANEX Gel, a topical formulation of recombinant human platelet-derived growth factor indicated as an adjunct to the treatment of lower extremity diabetic neuropathic ulcers.
The WARNINGS section of the label has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for it. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to REGRANEX Gel to 2,809 matched comparators. The results were consistent with no overall increase in cancer incidence among patients exposed to REGRANEX Gel, however, there was a five- fold increased risk of cancer mortality in the group exposed to three or more tubes of REGRANEX Gel, based on four cases. The types of cancers varied and were remote from the treatment site.
The BOXED WARNING states "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 Company has worked closely with the FDA to ensure that the REGRANEX Gel label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions. ETHICON, INC. is committed to broadly disseminating this new prescribing information about the safety of REGRANEX Gel through a "Dear Healthcare Professional" letter and its field-based employees.
"We remain confident in the safety and efficacy of REGRANEX Gel when used according to its label," said James C. Hart, MD, Vice President, Global Medical Affairs, ETHICON. "The benefits of REGRANEX Gel have been established in well-controlled studies and confirmed in clinical practice."
REGRANEX Gel, manufactured by OMJ Pharmaceuticals, Inc. for its distributor Ortho-McNeil, is commercialized in the United States by Johnson & Johnson Wound Management, a division of ETHICON, INC.
About REGRANEX Gel
REGRANEX Gel is the only FDA-approved prescription medicine that contains platelet-derived growth factor (PDGF), a substance that helps the body heal. It is applied directly to the ulcer. REGRANEX Gel, in conjunction with good wound care, has been proven to help heal diabetic ulcers more effectively than standard wound care. The product has been on the market for ten years and has been used to treat more than 750,000 patients.
Important Safety Information
REGRANEX Gel is contraindicated in patients with neoplasms at the site of application. An increased risk of mortality secondary to malignancy remote from the site of treatment has been observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. (See Boxed WARNING). However, in a separate analysis of cancer incidence, these results were consistent with no overall increase in cancer incidence (See WARNINGS). REGRANEX Gel should be used with caution in patients with known malignancy. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of this product (eg, parabens). Erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo gel. REGRANEX Gel should not be used in wounds that close by primary intention.
Please visit www.Regranex.com for the full Prescribing Information.
(C) ETHICON, INC. 2008 REGRANEX Gel is a registered trademark of Ortho-McNeil TM, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc.
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