-
FDA Wants Stronger Warning on Breast Implants About Risks
U.S. health officials want women getting breast implants to receive stronger warnings and more details about the possible risks and complications. The Food and Drug Administration said Wednesday that manufacturers should add a warning highlighted by a box — the most serious type — to the information given to women considering implants. The agency is also recommending patients complete a...
-
Clampdown on Vaping Could Send Users Back Toward Cigarettes
Only two years ago, electronic cigarettes were viewed as a small industry with big potential to improve public health by offering a path to steer millions of smokers away from deadly cigarettes. That promise led U.S. regulators to take a hands-off approach to e-cigarette makers, including a Silicon Valley startup named Juul Labs, which was being praised for creating “the...
-
Consumer Watchdog Agency Probes Juul and 5 More Vaping Firms
Federal consumer watchdogs have ordered Juul and five other vaping companies to hand over information about how they market e-cigarettes, the government’s latest move targeting the industry. The announcement Thursday from the Federal Trade Commission comes amid a nationwide crackdown on e-cigarettes as politicians and health authorities try to reverse an explosion of underage vaping by U.S. teenagers. The FTC...
-
E-Cigarette Maker Juul Facing Mounting Scrutiny by State AGs
E-cigarette giant Juul Labs is facing mounting scrutiny from state law enforcement officials, with the attorneys general in Illinois and the District of Columbia investigating how the company’s blockbuster vaping device became so popular with underage teens, The Associated Press has learned. The company’s rapid rise to the top of the multi-billion dollar U.S. e-cigarette market has been accompanied by...
-
A Decade After a Split, the Marlboro Men Seek a Reunion
Altria confirmed Tuesday that it is in talks to merge with Philip Morris International more than a decade after splitting itself into two companies. Altria has exclusively sold Marlboro and other cigarette brands in the U.S., while Philip Morris has handled international sales. Both companies have been investing in alternatives to traditional cigarettes amid declining smoking rates around the world....
-
Vaping Companies Sue to Delay US Review of E-Cigarettes
A vaping industry group sued the U.S. government on Wednesday to delay an upcoming review of thousands of e-cigarettes on the market. The legal challenge by the Vapor Technology Association is the latest hurdle in the Food and Drug Administration’s yearslong effort to regulate the multibillion-dollar vaping industry, which includes makers and retailers of e-cigarette devices and flavored solutions. The...
-
Breast Implant Recalled After Link to More Rare Cancer Cases
Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for certain textured models after regulators alerted the company to a heightened cancer risk with the devices. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface were tied to the vast majority of cases of...
-
US Experts: Too Soon to Pull Breast Implants Tied to Cancer
Government medical advisers said Monday it’s too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem. The Food and Drug Administration panel didn’t recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks...
-
E-Cigs Outperform Patches and Gums in Quit-Smoking Study
A major new study provides the strongest evidence yet that vaping can help smokers quit cigarettes, with e-cigarettes proving nearly twice as effective as nicotine gums and patches. The British research, published Wednesday in the New England Journal of Medicine, could influence what doctors tell their patients and shape the debate in the U.S., where the Food and Drug Administration...
-
US Goal to Be ‘First' on Devices Worries Former Regulator
Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. “We don’t use our people as guinea pigs in the U.S.,” Shuren said, holding firm as the new director of the U.S. Food and Drug Administration’s medical devices division. Again and again in 2011 — four times in all — Shuren...
-
Breast Implant Injuries Hidden as Patients' Questions Mount
To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year. Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA’s system. More...
-
FDA Approves 1st Nonopioid Drug to Ease Withdrawal Symptoms
Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids. The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. The pill was approved to treat adults for up to two weeks...
-
US Warns Liquid Nicotine Packets Resemble Juice Boxes, Candy
Liquid nicotine products that look like juice boxes, candies and other kids’ snacks came under government scrutiny Tuesday, as health authorities warned they could pose a danger to children. The Food and Drug Administration issued more than a dozen warnings over the illegal packaging practice, saying it can lead to poisoning if children mistakenly drink the liquids, which are intended...
-
FDA Puts Restrictions on Birth Control Implant But No Recall
U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market. The Food and Drug Administration said only women who read and have the opportunity to sign a brochure about the risks of the...
-
On Drug Costs, Modest Steps Follow Trump's Big Promises
President Donald Trump makes big promises to reduce prescription drug costs, but his administration is gravitating to relatively modest steps such as letting Medicare patients share in manufacturer rebates. Those ideas would represent tangible change and they have a realistic chance of being enacted. But it’s not like calling for Medicare to negotiate drug prices. Skeptics say the overall approach...
-
‘Take All Their Excuses Away': Hard Cases in Heroin Fight
Long before President Donald Trump declared the opioid crisis a national emergency and pledged to “overcome addiction in America,” addiciton counselor DeValle Williams was fighting in the trenches, where it’s tough to tell victory from defeat. More than 64,000 died of drug overdoses last year in the U.S., most from opioids. At 41, he’s been a counselor for two decades,...
-
US Approves Monthly Injection to Treat Opioid Addiction
U.S. health officials on Thursday approved the first injectable form of the leading medication to treat patients recovering from addiction to heroin, prescription painkillers and other opioids. The Food and Drug Administration approved once-a-month Sublocade for adults with opioid use disorder who are already stabilized on addiction medication. The monthly injection has the potential to reduce dangerous relapses that occur...
-
FDA Warns of Injury, Death With Herbal Supplement Kratom
Federal health authorities are warning about reports of injury, addiction and death with a herbal supplement that has been promoted as an alternative to opioid painkillers and other prescription drugs The supplement, kratom, made from a plant native to Southeast Asia, has gained popularity in the U.S. as a treatment for pain, anxiety and drug dependence. Users have opposed efforts...
-
Fact Check: Anti-Drug Ad Campaigns Fared Poorly in Past
President Donald Trump is promising a “massive advertising campaign” as part of his administration’s response to the worst drug crisis in U.S. history, but past marketing efforts have shown few results and experts say other measures could be far more effective in curbing the current epidemic....
Trump declared the country’s opioid overdoses a public health emergency on Thursday and laid out... -
FDA Expands Zika Screening to All US Blood Centers
The Food and Drug Administration wants all U.S. blood centers to start screening for Zika, a major expansion intended to protect the nation’s blood supply from the mosquito-borne virus.