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The US Food and Drug Administration on Thursday announced the approval of?the first generic version of EpiPen.The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition of anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.Allergies from food, bug bites, medications and latex can cause life-threatening reactions.The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.There are two other brand products on the market for a severe allergic reaction: Adrenaclick and Auvi-Q.The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's EpiPen."Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the approval.In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand. 1488

The U.S. Army has announced previously-scheduled leadership changes at Fort Hood as well as an investigation into the chain-of-command actions surrounding the case of Spc. Vanessa Guillen.Gen. Michael X. Garrett, commanding general of U.S. Army Forces Command, is directing that Maj. Gen. John B. Richardson IV formally assume duties as deputy commanding general for operations of III Corps and acting senior commander of Fort Hood.The change will take effect on Sept. 2.Army officials say the change in leadership was previously-scheduled and will enable "continuity of command" as III Corps returns from its role leading the Combined Joint Task Force-Operation Inherent Resolve.Maj. Gen. Richardson previously served as FORSCOM's director of operations from 2019-20 and was selected in March 2020 by the Department of the Army to serve as the next DCG for III Corps.Maj. Gen. Scott Efflandt will continue to serve as the deputy commanding general for support and will remain at Fort Hood to assist with the reintegration of III Corps as they return from their mission supporting Operation Inherent Resolve.With Maj. Gen. Efflandt remaining at Fort Hood, the Army will announce the name of a new commander for the 1st Armored Division, which Efflandt had previously been designated to lead. That announcement is expected in the coming days.The Army also announced that Sen. Garrett will appoint Gen. John Murray, commanding general of Army Futures Command, and one of the Army’s most senior commanders, to lead an in-depth investigation into the chain-of-command actions related to Spc. Vanessa Guillen.There are currently several investigations underway at Fort Hood. The Army says those investigations are tasked with reviewing a wide range of topics and concerns. According to the Army, Gen. Murray will roll those efforts into a more complete and comprehensive investigation that will delve into all activities and levels of leadership.Murray’s investigation, which will be conducted under the provisions of Army Regulation 15-6, is separate from the Independent Review of Fort Hood, which began in August.Full release: This story was first reported by Sydney Isenberg at KXXV in Waco, Texas. 2228

The US Food and Drug Administration has raised alarm about one way people might access opioids to misuse and abuse: their pets.As America's opioid epidemic rages, some pet owners could be stealing pain medications intended for their furry friends, according to a statement from FDA Commissioner Dr. Scott Gottlieb."We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals -- just as they do for people," Gottlieb said in Wednesday's statement."But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use," he said.Gottlieb also said there hasn't been much information about responsible opioid prescribing for veterinary medicine professionals, and so the FDA developed a resource guide on what veterinarians need to know.The resource includes information on state and federal regulations, alternatives to opioids and how to properly safeguard and store opioids, as well as how to identify if a client or employee may be abusing opioids and take action with a safety plan."While each state creates its own regulations for the practice of veterinary medicine within its borders, including regulations about secure storage of controlled substances like opioids, veterinarians should also follow professional standards set by the American Veterinary Medical Association in prescribing these products to ensure those who are working with these powerful medications understand the risks and their role in combatting this epidemic," Gottlieb said."Veterinarians are also required to be licensed by the Drug Enforcement [Administration] to prescribe opioids to animal patients, as are all health care providers when prescribing for use in humans," he said."These measures are in place to help ensure the critical balance between making sure animals can be humanely treated for their pain, while also addressing the realities of the epidemic of misuse, abuse and overdose when these drugs are diverted and used illegally by humans."The FDA statement came one week after a perspective paper in the American Journal of Public Health called for the veterinary, public health, pharmaceutical and regulatory communities to dedicate time and resources to addressing the issue of prescription opioid diversion in veterinary medicine."I was thrilled to see the FDA commissioner make a statement that not only validated our findings but also demonstrates why research is so important for good policy," said Liliana Tenney, a senior instructor with the Colorado School of Public Health at the University of Colorado Anschutz Medical Campus and deputy director of the Center for Health, Work & Environment, who was a co-author of the paper.Tenney was unaware of the FDA statement until CNN contacted her for an interview, she said.The paper included data from a 24-item online survey that 189 veterinarians in Colorado completed in collaboration with a local veterinary society. The survey, which was about the possible abuse and misuse of opioids by pet owners and the role veterinarians play in prevention, was administered in summer 2016, Tenney said.The survey results showed that 13% of the veterinarians were aware that an animal owner had intentionally made an animal ill or injured -- or seem to be ill or injured -- to obtain opioid medications."This is significant for two reasons. These providers want to ensure the treatment of pets," Tenney said. "If this is truly the case and pet owners are intentionally harming animals, that's an animal rights issue. If opioids are being prescribed and aren't getting to the pets that need them because these drugs are being diverted, that's a public health issue."The survey results also showed that 44% of the veterinarians were aware of opioid abuse or misuse by either a client or a veterinary practice staff member, and 62% believed that they had a role in preventing opioid abuse and misuse."We recognize that this ... sample, representing 10% of the society's members, has limited generalizability and cannot be used to extrapolate to all practices. Nonetheless, these data are sufficient to warrant immediate action," the authors wrote.American Veterinary Medical Association spokesman Michael San Filippo emphasized in a statement Wednesday that the association has provided resources for veterinary staff to help combat this issue and the association will continue to monitor the situation."Though our animal patients are not the ones struggling with opioid addiction, concerns about misuse and diversion are top-of-mind for the veterinary profession, and the AVMA is actively involved in providing resources to practitioners describing alternative ways to treat pain and minimize opioid use," the statement said."While the limited data available suggests diversion from veterinary practices isn't a widespread problem, that doesn't mean we should pretend it doesn't exist," it said. "In fact, AVMA policy calls for further research to determine the prevalence of veterinary drug shoppers and to further clarify the degree to which veterinary prescriptions are impacting, or not, the human opioid epidemic."? & ? 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved. 5456

The sidewalk vendors who have set up shop along the Mission Beach boardwalk may soon have to a find a new place to sell their wares. It's part of a series of regulations a City Council committee advanced at its meeting Thursday. The vendors have come in waves after a new state law decriminalized the practice, reducing any fines to administrative. The city, as a result, is no longer enforcing its rules that conflict with the law. As such, the vendors have set up shop along Mission Beach and other areas with heavy foot traffic. On Thursday, the boardwalk had vendors selling jewelry, sports team beach bags, and even tobacco pipes. "I hope they don't take this area away from us, the tourists love us and we just love this area to set up and vend," said Tina Saito, who was selling the pipes and rock necklaces on the boardwalk. The state law blocks the city from instituting restrictions based on economics, so it can't stop a vendor from opening outside an established business. The city can, however, enact regulations based on public safety. As such, the city's proposed ordinance would require food vendors - like the ones that lined Balboa Park at Pride earlier this month - to have county health permits and a food handlers card. It would also restrict hours in parks, and place a summer moratorium on vending in Balboa Park. The city would also block vendors from popular areas like Newport Avenue in Ocean Beach, Garnet Avenue in Pacific Beach, the Mission Beach boardwalk, the La Jolla Shores boardwalk, and the area around Petco Park on Padre game days. Finally, it would disallow vendors from selling things like alcohol, drug and tobacco paraphernalia, and weapons. Saito, who sells the tobacco pipes, called that potential decision disappointing. The city economic development committee instructed staff to get more input on the rules from vendors before they go to the full council in September. 1923

The Transportation Security Administration says they found three times the rate of loaded guns at checkpoints in July than they did at the exact time last year, despite fewer passengers traveling due to the coronavirus pandemic.In a press release, the agency said that 80% of the firearms that come through a checkpoint are loaded. "It’s just an accident waiting to happen," TSA Administrator David Pekoske said in the release.TSA said they found 15.3 guns per million people screened last month, which is up from the rate of 5.1 guns per million people in July 2019.The agency says that's alarming because they screened 75% fewer travelers last month.“TSA is diligently working to ensure our employees and passengers are safe and secure while traveling during a pandemic, and yet we are noticing a significant increase in loaded firearms coming into checkpoints,” said Pekoske in the press release. “Travelers must understand that firearms are prohibited items at airports and in the passenger cabins of aircraft. As hard as we are working to mitigate other risks at this time, no one should be introducing new ones.”Guns are permitted in checked bags, but they must be unloaded, and in a locked case, TSA said.Last year, 4,432 guns were found in carry-on bags at checkpoints nationwide, which is about 12.1 firearms per day, and 87% of them were loaded, the agency said. 1380

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