March 23, 2020 by Amy Kimberlain
Roundup: FDA to Require Warnings on ‘Immediate-Release’ Painkillers; Southern U.S. Hit Harder by Heart Disease, Study Finds
The U.S. Food and Drug Administration will require its strongest warning on “immediate-release” opioid painkillers in the ongoing effort by federal and state officials to ease the epidemic of prescription drug abuse.
The warning will alert users to the “serious risks of misuse, abuse, addiction, overdose and death” involved with taking opioids, a class of painkillers that includes morphine, Vicodin and Percocet. The warnings will appear on immediate-release painkillers, referring to the type of medications taken every four to six hours. The FDA is also requiring several additional changes in safety labeling across all prescription opioid products to include additional information on the risk of these medications.
In 2013, the FDA issued warnings on “extended-released” painkillers, which contain higher doses and are taken once or twice a day. Extended-release opioids pose unique risks, making them a target for abuse.
“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
Opioids are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine. About 40 Americans die every day from overdosing on prescription painkillers, according to the U.S. Centers for Disease Control and Prevention (CDC). In 2013, an estimated 1.9 million people abused or were dependent on prescription painkillers.
Last week, the CDC released opioid-prescribing guidelines for the first time. The guidelines urge doctors to avoid prescribing opioids for chronic pain that is unrelated to cancer or end-of-life care. The guidelines offer specific information on medication selection, dosage, duration, and when and how to reassess progress and discontinue medication if needed.
“Using this guideline, providers and patients can work together to assess the benefits and risks of opioid use,” the CDC states.
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Southern U.S. Hit Harder by Heart Disease
The demographics of heart disease deaths are shifting southward.
New research published this week in the American Heart Association’s journal Circulation found that deaths overall due to cardiovascular disease declined by almost 29 percent from 2003 to 2013. However, about 610,000 people still die of heart disease in the United States every year, accounting for one in every four deaths, says the U.S. the Centers for Disease Control and Prevention.
In the 1970s, the researchers found that the biggest concentration of high death rates from heart disease made up a broad swath of counties, spreading from the U.S. Northeast through parts of Appalachia and into the Midwest, and along coastal areas in North Carolina, South Carolina and Georgia.
But, by 2010 those high-rate clusters had shifted much more to the south, below the Mason-Dixon Line.
Counties recording the least progress — those with the slowest declines in heart disease death rates — ranging from 9 percent to about 50 percent were primarily in Alabama, Mississippi, Louisiana, Arkansas, Oklahoma and Texas. The counties with the fastest declines — or most progress — were located mostly in the northern half of the U.S., where heart disease deaths dropped by as much as 64 to 83 percent over the four decades (1970-2010).
The study did not find specific reasons behind the shifting geographic trends. But researchers pointed to factors in certain populations, including social and economic conditions, poor dietary habits, weak public policies, missed opportunities for physical activity, insufficient promotion of smoke-free environments and somewhat limited access to healthcare.
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Vitamin C Linked to Slower Cataract Progression
A diet rich in vitamin C might help slow down the progression of cataracts, a common eye condition in older adults that can start at 40 years of age, according to a new study.
Cataracts are characterized by the gradual opaqueness of the crystalline lens, which can lead to vision loss. It affects at least 24 million Americans, according to the American Academy of Ophthalmology. Treatment usually involves surgery — the removal of the natural lens and the implantation of an artificial intraocular lens (IOL).
In the new study conducted by the King’s College London, the diets of more than 1,000 female twin pairs were examined, with researchers seeking details about about vitamin C intake.
By the time they reached 60, digital images of their eyes were checked for opacity to measure cataract development, and 10 years after, 324 of these pairs underwent a follow-up.
The results showed that those who regularly ate foods rich in vitamin C were 20 percent less likely to develop cataracts. The percentage even increased a decade later when their cataract risk reduced to 33 percent. Foods rich in vitamin C include include citrus fruits, bell peppers, dark leafy greens, broccoli, berries, tomatoes, peas and papayas.
“The most important finding was that vitamin C intake from food seemed to protect against cataract progression,” said Dr. Christopher Hammond, one of the study author and ophthalmology professor at King’s College London.
For years, beta-carotene, which is derived from food such as carrots and eggs and is converted by the body into vitamin A, has been associated with healthy eyesight.
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