FDA Calls Kratom an Opioid

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The Food and Drug Administration (FDA) is warning that the supplement known as “kratom” is an opioid and has been linked with 44 deaths, The Washington Pos t reports. Kratom, an unregulated botanical substance, is used by some people to relieve pain, anxiety and depression, as well as symptoms of opioid withdrawal. The FDA recently conducted a scientific analysis that provided even stronger evidence of kratom’s opioid properties, the agency said in a statement. “We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” said FDA Commissioner Scott Gottlieb. The analysis has “contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.”
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FDA Asks Makers of Anti-Diarrhea Drug to Change Packaging to Curb Abuse

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The Food and Drug Administration (FDA) this week asked the makers of the over-the-counter anti-diarrhea drug loperamide (Imodium A-D) to change the way they package their products, in an effort to reduce abuse. Some people take extremely high doses of loperamide in an attempt to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use, the FDA said in a statement. Loperamide is safe when used at recommended doses, The Washington Post reports. But when it is taken at extremely high doses, the drug can cause dangerous, irregular heartbeats. The FDA is asking manufacturers to redesign their packages so they contain only enough medication for short-term use. The agency is also asking for “unit dose packaging,” such as blister packs that require a person to unpeel each dose separately.
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FDA Encourages Use of Medication-Assisted Treatment for Opioid Addiction

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The Food and Drug Administration (FDA) will encourage widespread use of medication-assisted treatment for opioid addiction, the agency’s commissioner said recently. The FDA has approved three medication-assisted treatment drugs: buprenorphine, methadone and naltrexone. A report issued last year by Pew Charitable Trusts concluded that medication-assisted treatment is the most effective way to deal with opioid use disorder. FDA Commissioner Scott Gottlieb, appearing before the House Committee on Energy and Commerce, said, “Unfortunately, far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications. In part, this is because insurance coverage for treatment with medications is often inadequate.” In his remarks, Gottlieb noted that some people may need medication-assisted treatment for years, if not for their entire lives. He said the FDA will issue guidance to drug manufacturers to promote the development of new addiction treatments, The Washington Post reports.
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FDA Requires Makers of Fast-Acting Opioids to Pay for Doctor Training

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The Food and Drug Administration (FDA) announced it will require makers of fast-acting opioids to fund voluntary training for healthcare professionals who prescribe the drugs, according to Reuters . The training will include education on safe prescribing practices and non-opioid alternatives. The FDA informed 74 manufacturers of immediate-release opioids that they will have to fund training for doctors, nurses and pharmacists. Companies that make extended-release and long-acting formulations of opioids already must pay for training of healthcare professionals. The FDA is also considering some type of mandatory education on opioids, the article notes. According to the FDA, approximately 160 million prescriptions a year – about 90 percent of all opioid pain medications prescribed in the United States – are for fast-acting formulations.
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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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