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About East Oregonian : E.O. (Pendleton, OR) 1888-current | View Entire Issue (April 22, 2015)
TV TIME Wednesday, April 22, 2015 East Oregonian Page 7A FDA: Safety problems prompted review of homeopathic remedies WASHINGTON (AP) — A top federal drug regulator says in- creased safety problems with ho- meopathic remedies contributed to the government’s decision to revis- it its oversight of the products this week. The Food and Drug Adminis- tration on Tuesday wrapped up a two-day meeting to hear from sup- porters and critics of products like Zicam Allergy Relief and Cold- Eeze, alternative remedies that are protected by federal law, but not accepted by mainstream medicine. Similar to dietary supplements, the FDA does not review the safe- ty or effectiveness of homeopathic remedies before they are sold. But unlike supplements, homeopathic medicines can state that they are in- WHQGHG IRU VSHFL¿F PHGLFDO V\PS- toms and conditions. The FDA’s Cynthia Schnedar, a director of drug compliance, said the agency has issued 40 warning letters to homeopathic product makers since 2009 amid increasing U.S. sales. In perhaps the most serious case, in 2009 the FDA ordered the maker of Zicam to stop market- ing three products that contained zinc gluconate. The agency linked those products to 130 reports from consumers who said they lost their sense of smell. In 2010, the FDA warned about reports of toxicity in children tak- ing Hyland Homeopathic’s teeth- ing tablets, which contained a ber- ry-derived toxin called belladonna that can be poisonous in larger doses. And last month the agency warned U.S. patients with asthma not to rely on homeopathic prod- ucts claiming to treat the respira- tory condition, which can cause fatal complications if not properly managed. Despite such problems Schne- dar stressed that this week’s FDA meeting was a “listening session,” and that the agency has not reached any decision about whether to alter its regulations. “We’re gathering information to allow us to consider whether to adjust the current enforcement pol- Television > Today’s highlights AP Photo/Eric Shelton This file photo shows Zicam Cold Remedy nasal gel. A top federal drug regulator says that increased safety problems with homeopathic remedies contrib- uted to the government’s deci- sion to revisit its oversight of the products. icies we have in place,” Schnedar said in an interview. The FDA hasn’t revisited its oversight of homeopathic prod- ucts since 1988, when it essentially exempted the industry from basic production standards that are man- datory for traditional drugs, like listing ingredients and dosibizng levels on product labels. Zicam and hundreds of other homeopathic remedies are often sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. But ho- meopathic medicine is based on a 200-year old theory unsupported by modern science: that ingredients which create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms. A key principle of traditional homeopathy holds that the more diluted a remedy is, the better it works. Today, many remedies marketed as homeopathic contain heavily diluted drugs, vitamins and minerals. For instance, Zicam con- tains a heavily diluted dose of zinc as its “active ingredient.” On Monday, industry executives and lobbyists argued that the cur- rent FDA framework works well for homeopathy. Representatives from the Consumer HealthCare Products Association, which rep- resents homeopathic manufactur- ers, emphasized that consumers like having easy access to alterna- tive treatments. But industry critics argued that many consumers do not understand how homeopathic products differ from conventional medicines. “Stocking homeopathic rem- HGLHV ODEHOHG IRU VSHFL¿F V\PS- toms or conditions alongside con- ventional over-the-counter drugs on the pharmacy or supermarket shelves is innately misleading,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center. She and others want the FDA to require homeopathic remedies to undergo the same safety and effec- tiveness reviews as conventional drugs. But failing that, Fugh-Ber- man said that the products should carry a disclaimer warning that they have not been shown to treat or prevent any disease or condition. WEDNESDAY MORNING 6 PBS ABC NBC CBS FOX STATION AM 6:30 (11) KFFX AgDay Paid Good Day Oregon News News KOIN 6 News at 6 a.m. 4:30 WakeUp North News 8 at Sunrise Northwest Northwest 4:30 KATU News Stretch W.L.Yoga (31) KTNW (59) OPB 13 Yoga/Yoga Wild K. 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