FDA

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OB/GYN Group Backs Over-the-Counter Birth Control

But move is unlikely anytime soon

(Newser) - Women shouldn't need a prescription or doctor's exam to buy birth control pills, the American College of Obstetricians and Gynecologists declared yesterday, in a statement that the AP says comes as something of a surprise given that the doctors who make up the organization make a lot of...

That Drug You Want? Sorry, There's Still a Shortage

Nationwide shortfall ultimately hurts 'the little guy'

(Newser) - Why would a paramedic in Ohio not administer morphine to a woman in pain? Because it was his last vial—and he wasn't alone in making such an agonizing decision, the New York Times reports. A nationwide drug shortage is leaving health care workers without a variety of drugs,...

Pharmacy Chief in Meningitis Outbreak Takes the Fifth

Barry Cadden sheds no light on what happened

(Newser) - The co-owner and chief pharmacist of the company linked to the meningitis outbreak arrived on Capitol Hill today for a grilling armed with lawyers and an index card. And when House lawmakers asked Barry Cadden of the New England Compounding Center things like what happened or what he might say...

FDA: Ameridose Is Rife With Contamination Issues

Bugs, leaks found inside drug firm linked to outbreak

(Newser) - The FDA's monthlong inspection of Ameridose, a firm with the same founders as the pharmacy linked to a deadly meningitis outbreak, has produced a long and troubling list of contamination issues, the AP reports. Inside the company's drug-making facility, federal inspectors found leaky, cracked walls and ceilings, insects...

FDA: Drug Co. Knew About Mold, Bacteria Contamination

Months before the meningitis outbreak

(Newser) - Staffers at a pharmacy linked to the deadly meningitis outbreak documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile, according to federal health inspectors. In a preliminary report on conditions at the pharmacy, the US Food and Drug Administration said today that...

Monster Energy Drinks Killed 5 People: Reports

Company denies responsibility in death of teenage girl

(Newser) - Do Monster Energy drinks have unsafe levels of caffeine? The company's products killed five people over the past year and a sixth in 2009, according to reports submitted by doctors and companies to the FDA. Parents in Maryland have already used the reports in a lawsuit against Monster, America'...

Feds Raid Firm Linked to Meningitis Outbreak

Agents probing New England Compounding Center

(Newser) - Criminal investigators from the Food and Drug Administration have raided the Massachusetts company whose steroid medication has been linked to a deadly meningitis outbreak. An FDA spokesman says the agents' work at the New England Compounding Center is part of the investigation into the outbreak, which has killed at least...

Less-Regulated Pharmacies Take Heat in Meningitis Crisis

'Compounding pharmacies' make drugs with weaker oversight

(Newser) - The death toll in an ongoing meningitis outbreak has hit five, with 35 sick in six states, the AP reports. What's more, hundreds or thousands could be at risk across 23 states after receiving potentially tainted steroid injections, and health providers are rushing to warn them of the danger....

20% of Supplements Illegally Labeled: Feds
 20% of Supplements 
 Illegally Labeled: Feds 
NEW REPORT
Oct 3, 2012 6:43 AM CDT

20% of Supplements Illegally Labeled: Feds

Diet and immune-boosting supplements make false, dangerous claims, feds say

(Newser) - Dieters beware: A new report has found that dozens of dietary supplements out there bear labels that make false, illegal claims that could pose a major threat to consumers, the AP reports. Federal investigators purchased 127 types of supplements both online and in stores and found that 20% made unsubstantiated...

Farm Antibiotics Make Us Sick

 Farm Antibiotics
 Make Us Sick 
scientists say
Sep 9, 2012 2:56 PM CDT

Farm Antibiotics Make Us Sick

Farm lobby resists attempts to regulate drug use

(Newser) - Why are people getting sick and dying from antibiotic-resistant infections? In part because of the food we buy at the supermarket, advocates say. With the farm industry buying most of America's antibiotics, and pumping it into animals like chickens and pigs, we may be munching on germs that have...

FDA Hastily OKing Risky Drugs
 FDA Hastily OKing Risky Drugs 
experts say
Sep 5, 2012 10:50 AM CDT

FDA Hastily OKing Risky Drugs

...warn experts. But the public may be OK with that

(Newser) - The FDA's commissioner has been touting the agency's speedy approval of new medicines—but it has brought risky drugs to market, according to two drug-safety experts. Specifically, Thomas J. Moore and Curt D. Furberg found problems with cancer drug Caprelsa, multiple sclerosis drug Gilenya, and stroke prevention drug...

FDA OKs 4-in-1 HIV Pill
 FDA OKs 4-in-1 HIV Pill 
Aug 27, 2012 5:29 PM CDT

FDA OKs 4-in-1 HIV Pill

Stribild combines 2 drugs sold as Truvada with 2 new drugs

(Newser) - The FDA today gave the green light to a new anti-HIV pill that combines four medicines to combat the virus that causes AIDS. The agency approved Gilead Sciences' Stribild as a once-a-day treatment to control HIV in adults who have not previously been treated for infection. The pill contains two...

Court Strikes Down Gross-Out Cigarette Labels

Court concludes that the government can't prove graphic warnings will work

(Newser) - The government can't force cigarette makers to put disgusting imagery warning of the dangers of smoking on their packages, a federal appeals court ruled today. In a 2-1 decision, the justices upheld a lower court ruling that the labels violated free speech protections, the AP reports. They said the...

FDA Greenlights 2nd Weight-Loss Drug

Qsymia the more effective of the pair in clinical trials

(Newser) - After 13 years without approving a new weight-loss drug, the FDA has now approved two within three weeks. After June's approval of Belviq , the FDA yesterday approved Qsymia, which used to be called Qnexa ; both drugs had previously been rejected. In studies, Qsymia resulted in the greater weight loss:...

FDA Bans BPA in Baby Bottles
 FDA Bans BPA in Baby Bottles 
Jul 17, 2012 2:30 PM CDT

FDA Bans BPA in Baby Bottles

...Because manufacturers had already stopped using it

(Newser) - Baby bottles and sippy cups can no longer contain the controversial chemical bisphenol-A, or BPA , the federal government announced today. The US chemical industry's chief association, the American Chemistry Council, had asked the Food and Drug Administration to phase out rules allowing BPA in those products in October, after...

FDA's Vast Email Spying Targeted 'Enemies List'

Agency looked at confidential information, made 'enemies list'

(Newser) - The email monitoring by the Food and Drug Administration started out as an investigation of five scientists suspected of leaking confidential documents to Congress and the press. But it soon grew into a wide-ranging "enemies list" against those pushing negative information about the FDA, peeking at thousands of emails...

Why I&#39;m Wary of the New Weight-Loss Drug Belviq
Why I'm Wary of the New Weight-Loss Drug Belviq
in case you missed it
Jul 8, 2012 10:51 AM CDT

Why I'm Wary of the New Weight-Loss Drug Belviq

Lindsay Beyerstein fears it's being viewed as the next fen-phen

(Newser) - The FDA has green-lighted the first new prescription weight-loss drug in 13 years—and Lindsay Beyerstein isn't exactly tossing confetti into the air at the news. Writing for Slate , she asserts that Belviq is no wonder drug: In trials, patients lost about 3% of their initial body weight, which...

FDA: Corn Syrup Can't Be Renamed 'Corn Sugar'

If it's not dry, it's not sugar, feds tell corn refiners

(Newser) - The Food and Drug Administration has nixed corn-refining giants' attempt to give high-fructose corn syrup a sweet-sounding new name on nutrition labels. The agency told the Corn Refiners Association that its product—which has been linked to weight gain and intelligence loss —cannot be renamed "corn sugar" because...

Worries Dog HIV-Blocking Little Blue Pill

Truvada could create drug-resistant HIV strain

(Newser) - A drug designed to block HIV infection comes with a little hitch: Used incorrectly, it could invite infection or create a resistant strain that renders the drug useless. The very FDA panel that recommended approval for the drug, Truvada, tangled with these dilemmas, the New York Times reports: What if...

FDA Panel Backs First Drug to Block HIV

Truvada, made by Gilead Sciences, is for healthy people at risk

(Newser) - A panel of federal health advisers has endorsed the first drug shown to prevent HIV infection in healthy people, clearing the way for a potentially landmark approval in the 30-year-old effort against the virus that causes AIDS. In a series of votes, the FDA advisory panel recommended approval of the...

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