Tag: fda
FDA: Breast implants cancer warning
Article via Fortune
The United States Food and Drug Administration (FDA) issued a statement on Wednesday about the seriousness of the known link between breast implants and a rare cancer, anaplastic large cell lymphoma (ALCL). At least 457 women in the U.S. have been diagnosed with breast implant-associated lymphoma, also referred to as BIA-ALCL, and nine of those women have died. The FDA is basing these numbers on medical device reports related to ALCL that it has received since 2010.
Officials at the FDA wrote, “We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL.” Despite being associated with implants, ALCL is not breast cancer. It is a rare blood cancer, a non-Hodgkin’s lymphoma, and can spread throughout the body. As a supplement to its Wednesday statement, the FDA also published a letter asking health care providers to continue to report possible cases of breast cancer-related ALCL to the agency.
The FDA first sounded the alarm on BIA-ALCL back in 2011. The World Health Organization has noted that since the link was identified two decades ago, ALCL has been linked with both implants saline- and silicone-filled implants.
Additionally, implants are linked to a heightened risk of developing ALCL regardless of whether they are smooth or textured. In November, a renewed investigation into the link between textured breast implants and the rare lymphoma forced several companies that manufacture textured implants, including Allergen and Mentor, to state that despite risks, they would not cease production. The companies urged physicians to continue to inform patients of potential risks associated with the implants.
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FDA Barges In on Vape Maker Juul, Seizes ‘Thousands’ of Documents
In its ongoing crusade against rad teens, the Food and Drug Administration announced Tuesday that it made a surprise inspection of the headquarters of Juul Labs, which is under investigation for potentially marketing e-cigarettes to children. The “unannounced on-site inspection,” executed on Friday, resulted in the seizure of “thousands of pages of documents,” according to the FDA.
The surprise inspection of Juul continues an aggressive new chapter in the FDA’s war on the “epidemic” of underage vaping, as FDA Commissioner Scott Gottlieb recently put it. The agency has cracked down on e-cigarette businesses in general and Juul in particular.
“The JUUL inspection, which we completed on Friday, sought further documentation related to JUUL’s sales and marketing practices, among other things, and resulted in the collection of over a thousand pages of documents,” the FDA said in a statement emailed to Gizmodo. “The inspection followed the Agency’s request for information that we issued to JUUL Labs in April for documents that would help us to better understand the reportedly high rates of youth use and the youth appeal of JUUL products, including documents related to marketing and product design.”
In a statement emailed to Gizmodo, Juul CEO Kevin Burns said his company plans to work with the FDA and other parties to prevent underage vaping and characterized the FDA’s surprise inspection on its headquarters as a “meeting.”
“We are committed to preventing underage use, and we want to engage with FDA, lawmakers, public health advocates and others to keep JUUL out of the hands of young people. The meetings last week with FDA gave us the opportunity to provide information about our business from our marketing practices to our industry-leading online age-verification protocols to our youth prevention efforts. It was a constructive and transparent dialogue,” Burns said. “We’ve now released over 50,000 pages of documents to the FDA since April that support our public statements. We look forward to presenting our plan to address youth access in the 60-day time frame as outlined by FDA. We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access.”
While there are hundreds of e-cigarettes on the market, Juul remains the most popular, especially among teenagers, according to Nielsen, which found that Juul represented nearly 55 percent of the e-cigarette retail market as of March.
In late August, the New York Times reported that management within PAX Labs, which created Juul before it spun off into its own company, knew the company’s e-cigarettes were widely popular with teenagers and still failed to tweak its marketing strategy, according to a former senior manager at PAX. Last month, the FDA announced that it had issued 1,300 “warning letters” and fines to brick-and-mortar e-cigarette retailers that the agency said it had busted selling Juul vapes to minors during an “undercover blitz” carried out this summer.
Although e-cigarettes are believed to be somewhat safer than tobacco cigarettes, and users can vape without nicotine, evidence shows they are still not safe, particularly for teens’ still-developing brains.
Article via: FDA Barges In on Vape Maker Juul, Seizes ‘Thousands’ of Documents
FDA recalls heart meds used to treat high blood pressure over cancer concerns
The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”
Officials say NDMA is classified as a probable human carcinogen —a substance that could cause cancer. They said those findings are based on results from recent laboratory tests.
The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”