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Experts Question Safety of Birth-Control Implant

Thousands of women have complained about Essure

(Newser) - Federal health experts today questioned the maker of Essure, a popular birth control implant that many women say caused long-term pain, bleeding, and fatigue. Since 2013, the FDA has received thousands of complaints about the device, often pitched as the only non-surgical option for permanent birth control, from women and... More »

FDA Bans Sales of 4 Brands of Cigarettes

They don't meet safety review requirements

(Newser) - The Food and Drug Administration is ordering a ban on sales of four cigarette brands from RJ Reynolds because they do not meet the agency's safety review requirements. Under FDA rules, companies that launch new cigarettes must show that the products are essentially the same as older products in... More »

FDA Fights Powdered Caffeine With ... Letters

Regulators don't have legal authority to pull it, so they issue warnings

(Newser) - The Food and Drug Administration has issued warning letters to five distributors of pure powdered caffeine, saying the products put consumers at risk. Caffeine powder is usually marketed as a dietary supplement and is unregulated, unlike caffeine added to soda. Since the FDA doesn't have the legal authority to... More »

FDA Lays Down the Law on Mayonnaise

Agency says Hampton Creek brand has to contain eggs to be considered mayonnaise

(Newser) - Unilever, maker of Hellmann's mayonnaise, has been fighting for some time against a "fraudulent" brand it says is encroaching on its own sales. Unilever dropped the suit in December , but the FDA has given the company a sort of win all the same. The agency has declared that... More »

'Female Viagra' Will Be on the Market in October

Flibanserin wins the approval of the FDA

(Newser) - The FDA approved a drug called flibanserin today, and the Washington Post explains the big deal: "The little pink pill has finally arrived." That is, the FDA gave its blessing to a drug commonly referred to as the female Viagra, the first one ever designed to boost the... More »

11-Year-Olds Can Now Be Prescribed OxyContin

FDA approves drug for severe pain in kids 11 to 16

(Newser) - The FDA has approved the powerful painkiller OxyContin for a new use in children 11 to 16 who are suffering from severe, long-term pain. OxyContin is an extended-release opioid that has long been used to treat around-the-clock pain in adults. But most pain medications are not approved for use in... More »

FDA Issues Warning Over Kardashian's Instagramming

Pregnancy drug promotion 'false and misleading'

(Newser) - If Kim Kardashian is going to promote drugs, she needs to talk about their side effects as well as their benefits, the FDA has warned a pharmaceutical company. Duchesnay, maker of the morning-sickness pill Diclegis, has received a formal warning from the regulator over Facebook and Instagram posts in which... More »

America's Thalidomide Hero Is Dead

FDA's Frances Kelsey kept dangerous drug off US markets

(Newser) - Dr. Frances Oldham Kelsey, who reshaped drug regulations at the FDA and—in the words of President Kennedy—"prevented a major tragedy" of birth defects in the United States, died yesterday at the age of 101, the New York Times reports. Kelsey joined the FDA in 1960 and was... More »

Even a Little Non-Aspirin Painkiller Could Be Bad News

Risk of heart attack, stroke from NSAIDs higher than thought, even in small amounts

(Newser) - The FDA advised back in 2005 that non-aspirin nonsteroidal anti-inflammatory drugs, or NSAIDs , could up the risk of heart attack and stroke. But the agency is now boosting that warning, noting that drugs like ibuprofen (often sold under the Motrin IB brand), naproxen (Aleve), and celecoxib (Celebrex) may pose a... More »

FDA OKs Pricey New Cystic Fibrosis Drug

It'll cost patients about $250K a year

(Newser) - Federal health officials have approved a new combination drug for the most common form of cystic fibrosis. But it will come at a steep price—more than $250,000 for a year's treatment. The FDA cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that... More »

FDA: Dump 'Heart Attack' Trans Fats in 3 Years

Obama gives food companies 3 years to phase out artificial trans fats

(Newser) - The Obama administration is cracking down on artificial trans fats, calling them a threat to public health. The FDA said today it will require food companies to phase out the use of artificial trans fats almost entirely. Consumers aren't likely to notice much of a difference, but the administration... More »

2 New Cholesterol Drugs May Be Game-Changers

FDA advisory panel recommends both after 2 days of hearings

(Newser) - A new batch of cholesterol-lowering drugs could bring new hope to patients who can't take popular statins, or for those who don't feel their effects. Today, an FDA advisory committee recommended approval of Amgen's Repatha, reports AP , just one day after it gave the green light to... More »

FDA: Dark Chocolate Often Not What It Seems

Unless you like milk in your dark chocolate

(Newser) - Like snacking on dark chocolate? Then we hope you're not doing it to avoid milk, because the US Food and Drug Administration tested 94 dark-chocolate bars and found milk in 61% of them, Quartz reports—including not just products with descriptions like "may contain milk" or "may... More »

Critics: Glaring Problem With FDA's Blood Donation Plan

Those in relationships could still be unable to donate

(Newser) - In December, the FDA revealed it would be ending a lifetime ban on gay men who seek to donate blood, and today, the agency has released its proposal . The FDA will unveil its final guidance after 60 days of public comment, the Huffington Post reports. While gay rights advocates say... More »

FDA OKs Shot to Zap Your Double Chin

Kybella injections said to be noninvasive, can be performed in 5 minutes

(Newser) - About 70% of participants in a 2014 survey by the American Society for Dermatologic Surgery about cosmetic procedures pointed fingers at chin and neck fat as a "top concern," per the Washington Post . But a drug just approved by the FDA looks to banish double chins, ABC News... More »

FDA to KIND: Your 'Healthy' Bars Aren't Really Healthy

FDA finds issues with how 4 bars are labeled

(Newser) - File under the "learn something new every day" category: The FDA regulates the use of a "+" in food labeling—and says KIND has been using it improperly on two of its snack bars. Bloomberg reports the FDA has taken issue with four KIND bars (list here ),... More »

Addicts Find Ways Around 'Abuse-Deterrent' OxyContin

People find new ways to dissolve the pills—or turn to heroin, study says

(Newser) - When an "abuse-deterrent" version of OxyContin was introduced in 2010, the intent was clear: "to make OxyContin more difficult to solubilize or crush, thus discouraging abuse through injection and inhalation," the New England Journal of Medicine noted in 2012. Made with special binders, the revamped pills would... More »

17 Patients Sick After Getting 'Simulated' IV Fluids

FDA opens inquiry over saline mistake

(Newser) - One patient died and 17 others got sick after at least 40 patients were given unsterilized intravenous fluids instead of the sterile saline solution they should have received. Officials aren't sure the unsterilized solution caused the death, which was of a hospice patient, the FDA notes. The fluids that... More »

FDA Lifting Lifetime Ban on Gay Men Donating Blood

But there will still be restrictions

(Newser) - The FDA announced today that it will lift its lifetime ban on blood donations from gay and bisexual men, the Los Angeles Times reports. Instead, men who have had sex with men will be allowed to donate blood one year after last having sexual contact with another man, the FDA... More »

FDA's New Calorie Rules Are a Bit of a Shock

They're more far-reaching than expected

(Newser) - Whether you're headed to Chili's or the movies, you'll soon be seeing a lot more calorie counts posted. The FDA is today announcing what a nutrition expert calls "one of the most important public health nutrition policies ever to be passed nationally," the New York ... More »

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