FDA

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FDA Advisers Reject Cold Meds for Kids

Popular remedies don't work and aren't safe for for children under 6

(Newser) - Over-the-counter cold medicines are dangerous for children under 6 and should not be used, a panel of health advisers reported to the FDA today. Many popular medicines, including Dimetapp, Triaminic, and Pediacare, have never been sufficiently tested on children under 12, the committee concluded. “The data that we have...

Viagra Linked to Hearing Loss
Viagra Linked to Hearing Loss
Oct 19, 2007 8:20 AM CDT

Viagra Linked to Hearing Loss

FDA puts warning label on popular sex drugs

(Newser) - Add hearing loss to the list of potential side effects of Viagra and other drugs to treat sexual dysfunction. The federal Food and Drug Administration will add a warning about the risk to the labels of Viagra, Cialis, Levitra and a hypertension drug, Revatio, which contains the same ingredient as...

Overdose Fears Prompt Recall of Infant Drugs

Danger found in cough and cold medicines for kids under 2

(Newser) - Several drugmakers have recalled over-the-counter cough and cold products for infants over concerns about fatal overdoses, Reuters reports. Johnson & Johnson Wyeth and Novartis are among those recalling medicines; CVS said it will remove the products and generic equivalents. One professor took the criticism one step further: “There are...

FDA Promises More Generics
FDA Promises More Generics  
Oct 5, 2007 9:19 AM CDT

FDA Promises More Generics

Commits to reviewing applications faster

(Newser) - The FDA approved about a third more generic drugs in fiscal 2007 than the year prior, and pledged yesterday to speed its review process to accommodate yet more. Sales of generics, which average about one-third the cost of their brand-name counterparts, are up 22%—and one advocacy group says the...

FDA May Ease Rx Drug Sales
FDA May Ease Rx Drug Sales
Oct 4, 2007 5:55 AM CDT

FDA May Ease Rx Drug Sales

Agency considers 'behind-the-counter' drug sales by pharmacists

(Newser) - The federal Food and Drug Administration may allow more drugs to be sold by pharmacists without a prescription if they are kept behind the counter off display shelves. The FDA  announced a hearing next month to explore the "public health benefit of drugs being available without a prescription but...

FDA May Ban Cold Medicines for Young Children

Overdoses are common, and death possible in kids under 6

(Newser) - FDA experts have concluded that over-the-counter cough and cold medicines are not safe  for very young children, and they're urging the agency to ban them. In a safety review released yesterday, they conclude that the medicines are not proven effective in children under 6 and have been implicated in more...

Lab Rats 'Treated Better Than Humans'

FDA slammed for inadequate oversight of clinical trials

(Newser) - Animals used in medical research have more rights and protections than humans who participate in clinical trials, according to a federal investigation. The Food and Drug Administration has only 200 inspectors to monitor 350,000 clinical trials and most of their field reports are ignored, reports the New York Times....

Senate Passes FDA Drug Safety Bill

Measure would give agency more power over prescription drugs

(Newser) - The Senate moved the Food and Drug Administration drug-safety bill one step closer to law yesterday, passing it unanimously and sending it to President Bush, who is expected to sign it. The measure would grant the FDA more control over warnings on prescription drugs, and would allow the organization to...

Antidepressant Warning Preceded Youth Suicide Surge

Unintended effect unfolded as use fell

(Newser) - Four years after the FDA and other agencies sparked a drop in antidepressant use by labeling the meds a suicide risk for young people, a new study shows the results were exactly the opposite of what regulators intended. From 2003 to 2004, the suicide rate among people under 19 rose...

FDA Eyes New Sunscreen Labels
FDA Eyes New Sunscreen Labels
Aug 23, 2007 2:58 PM CDT

FDA Eyes New Sunscreen Labels

Labels would include cancer warning and a rating system

(Newser) - The FDA is proposing new regulations for sunscreen labels, added a rating for protection from skin cancer as well as sunburn. Current sunscreen ratings for SPF—sun protection factor—cover only ultraviolet "B" rays, which cause sunburn. The FDA wants to start testing and rating products for ultraviolet "...

Dark Chocolate Gets Sweeter Every Day

Milk chocolate's healthier sibling grows more popular than ever

(Newser) - Overall chocolate sales are down, but Americans are increasingly indulging their sweet tooth with dark chocolate. The bitter, coffee-flavored treat is on the rise: Last year, dark chocolate sales surged 15% while sales of more popular milk chocolate dipped 5.5%. And boosted by claims of health benefits, dark chocolate...

Wal-Mart Owns Up to Melamine in Dog Treats

Company quietly pulled products as it waited for further testing

(Newser) - Two Chinese brands of dog treats sold at Wal-Mart contain a toxic chemical, the discount giant confirms. Customer complaints about the products prompted the company to quietly pull them from its shelves last month as it waited for further tests. The results confirmed the presence of melamine, the chemical at...

FDA Panel Votes to Keep Avandia on Shelves

Controversial diabetes drug still faces heart-attack link

(Newser) - An FDA panel said today that GlaxoSmithKline's diabetes drug Avandia should remain in drugstores, despite earlier evidence the pill ups heart failure risks. Glaxo has defended its drug, countering that the risks associated with the popular Avandia are the same as those of other diabetes drugs.

Dow Sinks Further on Credit Jitters
Dow Sinks Further on Credit Jitters
Jul 27, 2007 4:10 PM CDT

Dow Sinks Further on Credit Jitters

GDP report, earnings, can't stave off 208.10 point slide

(Newser) - Stocks tumbled more than 200 points for the second day in a row, on fears that small-cap securities might be especially hard hit by a possible collapse in certain financial services. The Dow was down 208.10 to 13265.47, despite a report that the GDP grew faster this quarter...

FDA to Regulate Cigarettes
FDA to Regulate Cigarettes
Jul 26, 2007 7:15 AM CDT

FDA to Regulate Cigarettes

Congress set to pass law to give feds power over toxic ingredients

(Newser) - Congress is set to pass a law today that will give the federal FDA the same power over tobacco it has over drugs and medical devices. Identical bills in both houses, hailed by the American Lung Association as a "win for public health," would allow the government to...

New Moms Use Natural Remedy for Depression

Placenta thought to help regulate volatile hormones

(Newser) - People think it's weird, and there's no research to prove it works, but new mothers  who've suffered from postpartum depression swear by it. The placenta that nourished the baby is injested by the new mom—dried and put into gelatin capsules, or just plain cooked and eaten. The placenta is...

Tainted Imports Originate All Over the World

FDA stats on food alerts show China has plenty of company

(Newser) - Contaminated Chinese seafood is the latest high-profile export turning American consumers off their feed, but they might want to save some caution for Dominican produce and Danish candy, FDA stats suggest. Inspectors stopped more food shipments from India and Mexico than from China in the past year, the Times reports,...

You Say 'Tomato,' FDA Says 'Not a Cancer Cure-All'

Study shows no link between lycopene and reduced risk of many types of the disease

(Newser) - Tomatoes and lycopene, the pigment that gives them their color, do not prevent cancer, the FDA says, contradicting preliminary research. Researchers analyzed 145 studies of lycopene, tomatoes, and cancer risk and found "no credible evidence" that the vegetable wards off lung, colorectal, breast, cervical or uterine cancers, according to...

Feds OK Alzheimer's Skin Patch
Feds OK Alzheimer's
Skin Patch
Jul 9, 2007 4:58 PM CDT

Feds OK Alzheimer's Skin Patch

New treatment gives patients, caregivers some peace of mind

(Newser) - A patch to treat symptoms of Alzheimer's disease cleared its final federal hurdle today, offering new hope to patients with the memory-sapping disorder—and the caretakers who worry about whether they're taking their meds. Exelon, which treats mild to moderate dementia, enters the bloodstream directly, regulating dosage and reducing the...

Salmonella Prompts Recall of Veggie Booty

Company yanks 'healthy' snack after dozens, including kids, fall ill

(Newser) - A snack popular with health-conscious junk-food fans because it contains kale and spinach may also contain salmonella, according to the FDA and CDC, and the manufacturer of Veggie Booty has issued a nationwide recall. Fifty-one people, many of whom had eaten the green-colored rice and corn curlicues, reported symptoms consistent...

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