FDA Requests Removal of Opana ER For Risks Related To Abuse

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The U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a...
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Weakening FDA’s Authority Over Tobacco Could Impact Use, Advocates Say

Weakening FDA’s Authority Over Tobacco Could Impact Use, Advocates Say
Weakening the Food and Drug Administration’s (FDA) regulatory authority over tobacco could have an adverse impact on tobacco use, according to advocacy groups. Congress is considering a bill that would allow flavored e-cigarettes and other non-traditional cigarette tobacco products to stay on the market, despite the enactment of a rule last year that gives FDA regulatory authority over all tobacco products, including e-cigarettes and cigars. “This is especially troubling because the Surgeon General has found that these flavors are particularly attractive to kids,” said Erika Sward of the American Lung Association. She noted that flavorings are believed to be a major cause of the more than 10-fold increase in e-cigarette use among high school-age students between 2011 and 2015. There is “real concern about what lies ahead for reducing tobacco use and, specifically, whether the FDA’s existing authority will be weakened,” she told MedPage Today .
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FDA Issues Warning Letters to Websites, Stores Selling E-Cigarettes to Minors

FDA Issues Warning Letters to Websites, Stores Selling E-Cigarettes to Minors
Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0in; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin;} The Food and Drug Administration (FDA) has issued warning letters to 24 websites for illegally selling e-cigarettes to minors, The Wall Street Journal reports. The agency banned e-cigarette sales to anyone under 18 years old earlier this year. The FDA also issued warning letters to 28 retailers of e-cigarettes and cigars, and three letters to websites that sell cigars. The websites and stores must respond in 15 days with an explanation of how they plan to prevent future underage sales, or risk being fined $275. “It’s clear from these initial compliance checks that there’s a need for strong federal enforcement of these important youth access restrictions,” Mitch Zeller, Director...
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FDA Urges Creation of Generic Abuse-Deterrent Opioid Painkillers

FDA Urges Creation of Generic Abuse-Deterrent Opioid Painkillers
The Food and Drug Administration (FDA) is urging makers of generic drugs to redesign opioid painkillers to make them abuse-deterrent, according to HealthDay . Medications with abuse-deterrent properties are more difficult to crush or dissolve, making them harder to snort or inject. If a medication has abuse-deterrent properties, “it does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death – notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole,” the agency said in a statement. “By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts,” FDA Commissioner Dr. Robert Califf said. “We hope that the availability of less costly generic products with abuse-deterrent properties has the potential to accelerate the shift away from...
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Opioid Painkillers Will Have to Carry “Black Box” Warning

Opioid Painkillers Will Have to Carry “Black Box” Warning
Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0in; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin;} The Food and Drug Administration (FDA) announced recently that it will require immediate-releaseopioid painkillers to carry a “black box” warning about the risk of misuse, abuse, addiction, overdose and death, CNN reports. Immediate-release opioids are usually intended for use every four to six hours, while extended-release opioids are generally intended to be taken once or twice a day. According to the FDA, 90 percent of opioid prescriptions are for immediate-release opioids. The FDA placed black-box warnings on extended-release opioids in 2013. Bottles for immediate-release opioids will have a notification stating there is a black-box warning for the drug. Patients will need to go to the manufacturer’s website for details,...
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