Claim: Cancer risk seen with J&J foot gel: FDA.
Verdict: SUPPORTS

Retrieved passages:
title: Tacrolimus
text: lymphoma and skin cancers. The risk appears to be related to the intensity and duration of treatment. The most common adverse events associated with the use of topical tacrolimus ointments, especially if used over a wide area, include a burning or itching sensation on the initial applications, with increased sensitivity to sunlight and heat on the affected areas. Less common are flu-like symptoms, headache, cough, and burning eyes. Tacrolimus and a related drug for eczema (pimecrolimus) were suspected of carrying a cancer risk, though the matter is still a subject of controversy. The FDA issued a health warning in March

title: Johnson's Baby
text: 2016, J&J was ordered to pay $72 million in damages to the family of Jackie Fox, a 62-year-old woman who died of ovarian cancer in 2015. She had used Johnson's Baby Powder for many years. J&J claimed that the safety of cosmetic talc is supported by decades of scientific evidence and it plans to appeal the verdict. The British charity, Ovacome was quoted as saying that while there were 16 studies which showed that using talc increased the risk of ovarian cancer by around a third, and a 2013 review of US studies had similar results for genital, but not

title: Pimecrolimus
text: real concern and they are increasingly recommending the use of such new drugs. Importantly, although the FDA has approved updated black-box warning for tacrolimus and pimecrolimus, the recent report of the American Academy of Dermatology Association Task Force finds that there is no causal proof that topical immunomodulators cause lymphoma or nonmelanoma skin cancer, and systemic immunosuppression after short-term or intermittent long-term topical application seems an unlikely mechanism. Another recent review of evidence concluded that postmarketing surveillance shows no evidence for this systemic immunosuppression or increased risk for any malignancy. However, strong debates and controversies continue regarding the exact indications

title: Squamous cell skin cancer
text: much more aggressive, regardless of their location. The risk of SCC, and non-melanoma skin cancers generally, varies with the immunosuppressive drug regimen chosen. The risk is greatest with calcineurin inhibitors like cyclosporine and tacrolimus, and least with mTOR inhibitors, such as sirolimus and everolimus. The antimetabolites azathioprine and mycophenolic acid have an intermediate risk profile. Diagnosis is confirmed via biopsy of the tissue(s) suspected to be affected by SCC. For the skin, look under skin biopsy. The pathological appearance of a squamous cell cancer varies with the depth of the biopsy. For that reason, a biopsy including the subcutaneous tissue

title: Modified risk tobacco product
text: make reduced risk claims or change warning label statements. , the FDA has accepted no applications for MRTP status and denied 18 applications. All applications for MRTP status to date have been for snus products, except for a single application for a heat-not-burn tobacco product (Philip Morris' iQOS). An MRTP application submitted by smokeless tobacco maker Swedish Match in 2014 was the first ever accepted for review by the FDA. On June 11, the 135,000-page MRTP application was submitted electronically to the FDA in compliance with formatting and data requirements. Swedish Match sought approval to remove warnings about mouth cancer,

title: Sunscreen Innovation Act
text: adjusted annually for inflation). The Melanoma Research Alliance supported the bill. In a video produced by the group, a melanoma survivor said that "when I heard that there were actually ingredients that the FDA is basically holding hostage, it infuriates me, it's crazy." The Centers for Disease Control and Prevention reported that in 2010 over 60,000 Americans were diagnosed with melanoma. The most common form of cancer in the United States is skin cancer. In 2009, chemical company and sunscreen manufacturer Ashland Inc. "significantly expanded its existing sunscreen production facilities in Columbus, Ohio, after the FDA announced it expected to

title: Johnson & Johnson
text: still went ahead and made the product available. In February 2016, J&J was ordered to pay $72 million in damages to the family of Jacqueline Fox, a 62-year-old woman who died of ovarian cancer in 2015: the company said it would appeal. By March 2017, over 1,000 U.S. women had sued J&J for covering up the possible cancer risk from its Baby Powder product; the company says that 70 percent of its Baby Powder is used by adults. In August 2017, a California jury ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian

title: Regeneron
text: of adult patients' atopic dermatitis. Approved by FDA on 28 March 2017. It is reported to cost $37,000 per year. KEVZARA (sarilumab injection) is an interleukin-6 (IL-6) receptor antagonist for treatment of adult patients with rheumatoid arthritis. Approved by FDA on 22 May 2017. LIBTAYO (cemiplimab injection) is a monoclonal antibody targeting the PD-1 pathway as a checkpoint inhibitor, for the treatment of patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Approved by FDA on 28 September 2018. Trap Fusion Proteins: Regeneron’s novel and patented Trap

title: Fluciclovine (18F)
text: Fluciclovine (18F) Fluciclovine (F), also known as anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid (FACBC), or as Axumin (brand name), and colloquially as anti-3[18F] FACBC or F18, is a diagnostic agent "indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels." Most imaging tests have not been able to localize recurrent prostate cancer when the PSA is mildly increased. Axumin scans were compared to [C]-tagged choline PET scans, another FDA approved PET scan that can assist in this situation, and to biopsy results. Fluciclovine tagged PET scans appear to more sensitive than CT

title: Cancer vaccine
text: of a phase III clinical trial. The approval is for a subset of kidney cancer patients who are at intermediate risk for disease recurrence. It awaits approval in the US and EU. but will need a new trial for FDA approval. Interim results from a phase III trial of talimogene laherparepvec in melanoma showed a significant tumour response compared to administration of GM-CSF alone. Oncophage was approved in Russia in 2008 for kidney cancer. It is marketed by Antigenics Inc. Sipuleucel-T, Provenge, was approved by the FDA in April 2010 for metastatic hormone-refractory prostate cancer. It is marketed by Dendreon

title: Fluorouracil
text: Fluorouracil Fluorouracil (5-FU), sold under the brand name Adrucil among others, is a medication used to treat cancer. By injection into a vein it is used for colon cancer, esophageal cancer, stomach cancer, pancreatic cancer, breast cancer, and cervical cancer. As a cream it is used for actinic keratosis, basal cell carcinoma, and skin warts. When used by injection most people develop side effects. Common side effects include inflammation of the mouth, loss of appetite, low blood cell counts, hair loss, and inflammation of the skin. When used as a cream, irritation at the site of application may occur. Use

title: Canagliflozin
text: medication without first talking to their doctor. On December 4, 2015, the FDA issued another safety communication for SGLT2 inhibitors, indicating that it would require new warnings to be added to the canagliflozin label about elevated blood acid levels and urinary tract infections. A June 29, 2016 report on the ongoing cardiovascular outcomes trial for canagliflozin (CANVAS) revealed interim findings of new safety concerns including heightened risk of bone fracture that was found to increase with the duration of treatment. On May 16, 2017, the FDA concluded that canagliflozin causes an increased risk of leg and foot amputations. The FDA

title: Modified risk tobacco product
text: The FDA has also accepted applications from the R. J. Reynolds Tobacco Company for removing warnings from its Camel Snus product and from Philip Morris International for permission to market its heat-not-burn tobacco product iQOS as safer than a traditional cigarette. At the conclusion of public meetings hosted by the FDA on April 9–10, 2015, the Tobacco Products Scientific Advisory Committee (TPSAC) voted against recommending a labeling change that would give Swedish Match's snus product a modified risk designation. The committee tied 4-4 in a yes or no vote when asked whether the snus product demonstrated substantially lower risk compared

title: Amcinonide
text: to begin production of Amcinonide cream in 2002 after proving the product was bioequivalent to Cyclocort products already on the market. This was the first generic Amcinonide product to be sold in the United States, thus introducing a lower-priced alternative for patients with applicable dermatological ailments. In 2003, Fougera Pharmaceutical became the main competitor to Taro after acquiring FDA approval for production of 0.1% Amcinonide cream. In 2009, Taro Pharmaceuticals was warned by the FDA that they were not meeting good manufacturing practices for their ointment and that their final product was non-sterile. Following additional FDA investigations, this was eventually

title: Sirolimus
text: mortality due to an increased risk of infections. According to the FDA prescribing information, sirolimus may increase an individual's risk for contracting skin cancers from exposure to sunlight or UV radiation, and risk of developing lymphoma. In studies, the skin cancer risk under sirolimus was lower than under other immunosuppressants such as azathioprine and calcineurin inhibitors, and lower than under placebo. Individuals taking sirolimus are at increased risk of experiencing impaired or delayed wound healing, particularly if they have a high body mass index (i.e., a BMI of ≥30 kg/m). Sirolimus is metabolized by the CYP3A4 enzyme and is a

title: Mesoblast
text: in patients who are resistant to traditional treatments. Preliminary data from two interim analyses planned under the protocol provided encouraging results. The Phase 3 trial is ongoing. On September 30, 2014, Mesoblast announced that its Japanese partner, JCR Pharmaceuticals Co Ltd (JCR), filed with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to receive approval for manufacturing, marketing, and product registration of the allogeneic or "off-the-shelf" Mesenchymal Stem Cell (MSC) product JR-031 for the treatment of acute graft versus host disease (GVHD) in children and adults. Mesoblast plans to file production registration with the U.S. FDA in 2016 and will

title: Arbonne International
text: the risk of contamination with the Pseudomonas aeruginosa organism. In January 2013, Health Canada advised of Arbonne's voluntary recall of one batch of branded facial moisturizer for men. Arbonne's testing found that the batch contained the bacterium Aerococcus viridans. In January 2014, the Australian Competition & Consumer Commission (ACCC) recalled sample tubes of branded day cream due to the presence of bacteria Enterobacter gergoviae. In June 2016, Arbonne voluntarily recalled multiple lots of branded liquid eye liner. The products contained unacceptable levels of bacteria: Staphylococcus saprophyticus, Staphylococcus xylosus, and Staphylococcus lentus. In October 2017, the ACCC recalled one lot of

title: Mohs surgery
text: for uncomplicated, non-melanoma skin cancer of less than one centimeter in size. On these parts of the body, the risks exceed the benefits of the procedure. Due to high risk of recurrence among other reasons, Mohs surgery could be considered for skin cancers on hands, feet, ankles, shins, nipples, or genitals. In 2012 the American Academy of Dermatology published appropriate use criteria (AUC) on Mohs micrographic surgery in collaboration with the following organizations: American College of Mohs Surgery; American Society for Mohs Surgery; and the American Society for Dermatologic Surgery Association. More than 75 physicians contributed to the development of

title: Chemence
text: the Nexcare brand. In 2005, Chemence Medical began manufacturing its own line of FDA-registered medical device products including Liquid Skin skin protectant, Derma+Flex liquid bandage, Derma+Flex gel tissue adhesive (CE marked), Salon Safe liquid bandage, Sure Close wound closure kit, Derma+flex QS gel tissue adhesive, Gluture veterinary glue, Exofin tissue adhesive, Exofin micro and Exofin Fusion skin closure system. In 2007, the company negotiated the sale of the intellectual property rights for the RITE-LOK range of industrial adhesives and sealants to 3M. In 2011, 3M rebranded the RITE-LOK product range to Scotch-Weld. In 2012, Chemence Ltd. re-launched their own range

title: Epoetin alfa
text: on February 16, 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings. In addition, on March 9, 2007, drug manufacturers agreed to new black box warnings about the safety of these drugs. On March 22, 2007, a congressional inquiry into the safety of erythropoeitic growth factors was reported in the news media. Manufacturers were asked to suspend drug rebate programs