Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Tuesday, March 29, 2011

Artificial Food Dyes Scrutinized by FDA - WSJ.com

A Food and Drug Administration panel plans to meet this week to consider the potential link between hyperactivity in children and artificial dyes found in common foods such as candy, waffles and salad dressing.

The FDA is reconsidering its long-held position that the dyes pose no risk to children or anyone else. Artificial food dyes with names like Yellow 5 have long been targeted by some scientists and consumer advocates concerned that they could cause hyperactivity in children.

The panel, which will meet Wednesday and Thursday, is expected to possibly call for more research. It isn't expected to take bigger steps such as banning artificial coloring.

Associated Press

M&Ms contain artificial food dyes.

DYE
DYE

The FDA signaled the first change in its thinking last week in a memo that said artificial food dye is an issue "for certain susceptible children with ADHD [attention deficit hyperactivity disorder] and other problem behaviors." The FDA said there isn't a link between hyperactivity and food dyes in the general population.

"The data suggest that their condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, artificial food colors," the FDA memo s

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Drug Shortages Distress Hospitals - WSJ.com

A shortage of injectable generic drugs for cancer and other serious diseases is putting pressure on hospitals, which are sometimes having to scramble to locate the medicines or search for alternative treatments.

The supply of these drugs has tightened in recent years as the generic-drug industry has consolidated, with many of the drugs now made by just one or two companies. In many cases patents have long expired and the original brand-name drug is no longer being produced.

Federal regulators have also stepped up enforcement of quality standards, limiting the ability of large manufacturers to ramp up production.

The drugs—typically used in hospitals and outpatient clinics—often require complex manufacturing processes with long lead times. Because factories produce many kinds of medicines, companies say they can't easily make more of one without creating a shortage in another.

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Sunday, January 16, 2011

FDA seeks less acetaminophen in prescription drugs | Reuters

U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage.

The move announced on on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a "black box" warning about potential liver failure.

Some of these medicines now contain as much as 750 milligrams of acetaminophen, a drug also sold over the counter in lower doses as a generic painkiller and Johnson & Johnson's Tylenol.

"This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem," the U.S. Food and Drug Administration wrote in a public notice.

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Wednesday, January 5, 2011

Exhausted by Chronic Fatigue Syndrome, and Its Doubters - NYTimes.com

Chronic fatigue syndrome causes a host of debilitating symptoms: profound exhaustion, disordered sleep, muscle and joint pain and severe cognitive problems, among others. But what causes the syndrome itself?

Well

Share your thoughts on this column at the Well blog.

Go to Well »

Since the first cases in the United States were identified in the 1980s, scientists have been divided over that question. Some have suspected that one or more viral infections are likely to play a central role.

But many other researchers — not to mention relatives, friends, employers, doctors and insurers of the million or more Americans estimated to suffer from the illness — have dismissed it as stress-related, psychosomatic or simply imaginary.

Now recent back-to-back announcements have highlighted both the volatility of the issue and the ambiguity of the science, and have alternately heartened and dismayed patients.

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Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, won't be available until next month. The approval figures don't include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market. Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.

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Sunday, December 5, 2010

Medical News: FDA Panel Says Okay to Lower BMI for Lap-Band - in Primary Care, Obesity from MedPage Today

An FDA advisory committee voted 8 to 2 that Allergan's Lap-Band device is safe enough to use in patients with a BMI as low as 30.

The stomach-shrinking device is currently approved for weight loss in people who are at least 100 pounds overweight or have a body mass index (BMI) of at least 40, or a BMI of at least 35 with other comorbidities such as heart disease.

Allergan is looking for approval to lower those BMI cutoffs to 35 and 30 respectively.

If the FDA follows the advice of its advisory committee the Lap-Band could be an option for another 27 million Americans.

The Lap-Band is an adjustable silicon band that is implanted through tiny incisions around the upper stomach. It works by reducing stomach capacity and thus the amount of food the stomach can hold. Its use involves a less invasive procedure than gastric bypass or stomach stapling, but it is also less effective, FDA reviewers noted in briefing documents released in advance of Friday's meeting.

The FDA's Gastroenterology and Urology Devices Panel spent Friday discussing Allergan's single-arm study of 143 patients with the lower BMI criteria.

All 143 had significant reductions in weight and BMI after one year, with only 37% still meeting the criteria for obesity.

After one year, eight out of 10 Lap-Band recipients lost at least 30% of their excess weight, and 66% lost at least half.

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Wednesday, November 17, 2010

FDA expected to ban alcoholic energy drinks - Health - Addictions - msnbc.com

The Food and Drug Administration is poised to announce a virtual ban of alcoholic energy drinks on Wednesday, even as a leading manufacturer is pulling its products off the market.

The FDA is expected to say that caffeine is an unsafe food additive to alcoholic drinks, a move that would effectively ban them from sale. College students have been hospitalized after drinking the beverages, including the popular Four Loko, and four states have banned the drinks.

Phusion Projects, which manufactures Four Loko, announced late Tuesday that it would reformulate its drinks, removing caffeine. While there is little known medical evidence that the drinks are less safe than other alcoholic drinks, public health advocates say they can make people feel more alert and able to handle risky tasks like driving.

The company's statement said it was removing caffeine from the drinks after unsuccessfully trying to deal with "a difficult and politically-charged regulatory environment at both the state and federal levels."

"We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe," said Chris Hunter, Jeff Wright and Jaisen Freeman, who identify themselves as Phusion's three co-founders and current managing partners.

The statement did not mention several recent incidents in which college students were hospitalized after drinking the beverage. In response to such incidents, four states — Washington, Michigan, Utah and Oklahoma — have banned the beverages. Other states are considering similar action.

Four Loko comes in several varieties, including fruit punch and blue raspberry. A 23.5-ounce can sells for about $2.50 and has an alcohol content of 12 percent, comparable to four beers, according to the company's website.

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Thursday, November 11, 2010

FDA Proposes Graphic Warnings For Cigarette Packs, Ads : Shots - Health News Blog : NPR

Shots - NPR's Health Blog

Shots - NPR's Health Blog

by Scott Hensley and Richard Knox

Proposed warnings for cigarette packages
FDA

Coming soon: Bold health warnings for cigarette packages and advertisements.

Now that the Food and Drug Administration has broad powers to regulate tobacco, it's starting to flex its muscles.

Today, the agency unveiled a proposal that would add large, dramatic warnings to cigarette packages and advertisements in a move to discourage people from smoking.

The Tobacco Control Act requires the FDA to come up with regulations for tougher labeling of cigarettes. Now you can see the agencies' ideas and comment on them through early January. Final regulations are due next June. Tobacco companies will have until September, 2012, to make the changes.

 

Under the law, these warnings will have to appear on both the front and back of cigarette packs, taking up half the real estate on each side of the label.

In big ads, they're supposed to occupy at least 20 percent of the space. For smaller ads, there will be alternative anti-smoking messages with bright logos.

Will they work? Some research shows that bold graphic warnings do a better job than text alone in communicating risks and affecting behavior. Other countries, such as Canada, have blazed this trail already.

As NPR's Richard Knox reports on All Things Considered, David Sweanor, a law professor at the University of Ottawa, says Canada's decade-old warnings do work — up to a point.

"What we see with these sorts of warnings is that it does increase motivation," Sweanor says. "People are more aware of the risks. They are wanting to quit. But that has to be combined with services that make it more likely."

Sweanor says smoking hasn't gone down as much as Canada as they'd hoped because the government hasn't provided enough access to smoking cessation programs.

The U.S. government's new campaign, powered by a new 2009 tobacco control law, does include more coverage of quit-smoking programs through Medicare, Medicaid and private insurance. But some wonder if the funding will materialize.

Others say the scare tactics can sometimes backfire. One study that tested warnings on a bunch of smokers, who happened to be psychology students, found that when smoking was a big part of someone's self-esteem, they weren't deterred by warnings that cigarettes could kill them. In fact, paradoxically, the death warnings might make them want to smoke more.

For those people, the researchers say, it might be more effective to dent that self-esteem with messages that say things like "Smoking makes you unattractive."

Almost two decades ago, comedian (and smoker) Denis Leary poked fun at smokers' ability to ignore warnings in a scathing, very unscientific and yet on-the-mark bit:

It doesn't matter how big the warnings are. You could have cigarettes that were called the warnings. You could have cigarettes that come in a black pack, with a skull and crossbone on the front, called "Tumors," and smokers would line up around the block saying, "I can't wait to get my hands on these [bleeping] things."

But the FDA is betting big that scare tactics will work on some of the 47 million Americans who still smoke – and deter more teenagers from starting. Smoking prevalence has stalled at 20 percent of adults – and, ominously, about the same proportion of high school seniors.

Tobacco companies didn't have much to say about the new warning labels – although a spokesman for R.J. Reynolds notes that the company has already filed a suit challenging the constitionality of the warning label requirements, on First Amendment grounds.

 

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abbey baskan (thinkstraight)

abbey baskan (thinkstraight) wrote:

@whoam(Inow): Of course smoke from cars bother me, too. But not only is that NOT the topic here, the analogy actually makes my point. We have limits on what can come out of the back of a car. That has allowed us to come a long way in cleaning up the air in many parts of the world. At least we did "regulate" that and it worked, albeit to varying degrees. Here, doing nothing is the worst alternative.

Thursday, November 11, 2010 2:27:37 PM

Rita Serrano (senorita)

Rita Serrano (senorita) wrote:

People will carry the cig pack in a holder of some type where the pictures will not be visible. This type of packaging will stop people from smoking.

Thursday, November 11, 2010 1:35:35 PM

Don Smith (veggiebreeze)

Don Smith (veggiebreeze) wrote:

Once the smoker is hooked there is little need to warn of the health risks. Anyone who awakens and hacks for 15 minutes, or who gets short of breath walking down the driveway to the mailbox, knows that cigarettes are slowly killing him. But it is up and coming smokers who might be disuaded by graphic warnings. I was once leaving a party and a young woman lit up. Her friend was dismayed and said, "Don't you know those things give you cancer?" The woman replied, "Yeah, but that stuff comes on slowly."
Parents (smokers or not) do whatever it takes to keep your kids from becoming fodder for tobacco profits.

Thursday, November 11, 2010 1:34:25 PM

Art Aficionado (Art_Aficionado)

Art Aficionado (Art_Aficionado) wrote:

An NPR moderator has removed this comment because it does not adhere to the discussion guidelines

Thursday, November 11, 2010 1:01:22 PM

m e (jmar19)

m e (jmar19) wrote:

@Amphitere of course there are some who don't know smoking is bad for their health, but the vast majority in the US do know and assume they will quit before it gets the better of them. For that matter, most people many not be aware that it isn't just lung cancer that afflicts smokers but also esophageal cancer, pancreatic cancer and not to mention 100s of other diseases more prevalent amongst smokers, or the fiscal impact it imparts on our healthcare system, but sadly even that knowledge and understanding won't speak as loudly as tobacco addiction. Quitting is hard, most people DON'T appreciate that. These labels aren't going to make a big impact, no more than the current written warnings or advertisement warnings or campaigns that flood the TVs and schools about the health impact of smoking. Public policy that gets at the heart of smoking convenience DOES make a difference, increasing the tax on tobacco products, making it illegal to smoke indoors, on patios and on the beach or near schools, for example, that makes a difference, albeit most smokers hate it and say they have the right to do whatever they want to their bodies, which is true to some extent, unless they ave kids or harm others with their second hand smoke.

Thursday, November 11, 2010 12:53:48 PM

Tell Me (WhatToThink)

Tell Me (WhatToThink) wrote:

Hard to imagine, but as a former smoker I can tell you that one does not need the FDA or anyone to tell you that smoking is bad for you, and no smoker would have believed that it wasn't harmful despite the industry's claims (as if stanley tools could tell me hitting myself on the head with a hammer was harmless and they'd somehow be culpable for me splitting my skull). Graphic pictures on packs is going to do nothing whatsoever.

Thursday, November 11, 2010 12:41:05 PM

James Broderick II (Amphitere)

James Broderick II (Amphitere) wrote:

jmar19: Sadly, what you say is not the case. There are still PLENTY of people who don't believe smoking is bad for you, and plenty MORE who don't believe smoking is /that/ bad for you. Sad, no?

Thursday, November 11, 2010 12:20:39 PM

who am (Inow)

who am (Inow) wrote:

PS as a smoker I am fine about the warnings. the stuff is way addictive. more so than opium according to the docs.

Thursday, November 11, 2010 12:19:37 PM

who am (Inow)

who am (Inow) wrote:

"Just today as I was walking down the street the man in front of me a couple of paces was smoking and I couldn't get out of the way without breathing in what came out of his lungs!"

lol but the cars didn't bother you?

Thursday, November 11, 2010 12:18:24 PM

who am (Inow)

who am (Inow) wrote:

and the tabacco industry is going to use "freedom of speech' to say "NO"

Thursday, November 11, 2010 12:16:04 PM

View all comments (157)»

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856-415-9617, (fax) 415-9618

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