Nursefriendly.com: food and drug administration

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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.

via reuters.com

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Saturday, January 15, 2011

Oregon sues Johnson & Johnson over "phantom" Motrin - Jan. 13, 2011

Oregon has sued Johnson & Johnson for allegedly selling defective Motrin drugs to consumers in the state for more than a year, and for trying to secretly remove the faulty drugs from stores.
"Companies that break the rules and put consumers at risk will be held accountable," Oregon Attorney General John Kroger said in a statement.

The state filed the lawsuit Wednesday against J&J (JNJ, Fortune 500) and its two subsidiaries, McNeil PPC Inc. and McNeil Healthcare Inc. The company's McNeil division makes over-the-counter cold and pain drugs such as Tylenol, Motrin and Benadryl.

The suit claims that J&J discovered in late 2008 that some supplies of Motrin sold in gas stations and convenience stores nationwide were defective because they were not properly dissolving.

via money.cnn.com

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Monday, January 10, 2011

What Does the New Food Safety Law Mean for You? | FoodSafety.gov

Just before Christmas, the House of Representatives and the Senate passed the FDA Food Safety Modernization Act, which President Obama signed into law on January 4, 2011. Here’s a quick look at some of the provisions in the new law:

Issuing recalls: For the first time, FDA will have the authority to order a recall of food products. Up to now, with the exception of infant formula, the FDA has had to rely on food manufacturers and distributors to recall food voluntarily.
Conducting inspections: The law calls for more frequent inspections and for those inspections to be based on risk. Foods and facilities that pose a greater risk to food safety will get the most attention
Importing food: The law provides significant enhancements to FDA's ability to oversee food produced in foreign countries and imported into the United States. Also, FDA has the authority to prevent a food from entering this country if the facility has refused U.S. inspection.
Preventing problems: Food facilities must have a written plan that spells out the possible problems that could affect the safety of their products. The plan would outline steps that the facility would take to help prevent those problems from occurring.

via foodsafety.gov

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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?

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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.

via nytimes.com

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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.

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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.

via online.wsj.com

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Sunday, January 2, 2011

Drug recalls surge to more than 1,700 in 2009 - Aug. 16, 2010

Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.
The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."

via money.cnn.com

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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.

via medpagetoday.com

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Wednesday, November 17, 2010

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

WASHINGTON — 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.

via msnbc.msn.com

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Sunday, January 16, 2011

FDA seeks less acetaminophen in prescription drugs | Reuters

Saturday, January 15, 2011

Oregon sues Johnson & Johnson over "phantom" Motrin - Jan. 13, 2011

Monday, January 10, 2011

What Does the New Food Safety Law Mean for You? | FoodSafety.gov

Wednesday, January 5, 2011

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

Well

Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

Sunday, January 2, 2011

Drug recalls surge to more than 1,700 in 2009 - Aug. 16, 2010

Sunday, December 5, 2010

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

Wednesday, November 17, 2010

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

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