Two popular anti-smoking drugs will now carry warnings about the risk of severe mental health problems, the Food and Drug Administration announced Wednesday.
A government advisory panel voted Tuesday to recommend eliminating prescription drugs that combine acetaminophen with narcotics -- such as Vicodin and Percocet -- because of their risk for overdose and for severe liver injury.
A government advisory panel began voting Tuesday on recommendations for reducing the risk of serious liver injury associated with acetaminophen, found in over-the-counter drugs such as Tylenol and NyQuil.
The tobacco industry was once a well-funded behemoth in American politics, and while Big Tobacco's power is slowly eroding, its influence is far from gone.
Consumers should discontinue use of Zicam Cold Remedy nasal gel and related products because they can can permanently damage users' sense of smell, the government said Tuesday.
A bill that increases the power of the Food and Drug Administration to regulate the manufacturing, marketing and sale of tobacco products cleared the Senate on Thursday.
The U.S. Senate Thursday backed a plan giving the Food and Drug Administration power to regulate cigarettes and other tobacco products, allowing the agency to curb advertisements, require stronger package warnings and inspect manufacturers.
In 2008, according to documents obtained by Sports Illustrated through a Freedom of Information Act request, the FDA received a variety of adverse health event reports from consumers using supplements. The bad reactions range from a man whose heart rate was stuck at 147 beats per minute (p. 39, PDF 1) for two hours after he took a product called Fireball Liquifusion, to a woman who experienced shortness of breath and shaky hands after using an energy and weight loss product that was sold to her out of the back room of a supplement store and that illegally contained ephedrine (p. 41, PDF 1). As noted in the FDA report, "this product appears to be readily available on the Internet."
Reports of young children developing premature or inappropriate sex characteristics have prompted the U.S. Food and Drug Administration to require a boxed label warning on two testosterone gel products.
Several associations in the alternative medicine industry have joined forces to warn against non-conventional remedies that claim to cure or prevent swine flu.
Two popular anti-smoking drugs will now carry warnings about the risk of severe mental health problems, the Food and Drug Administration announced Wednesday.
A government advisory panel voted Tuesday to recommend eliminating prescription drugs that combine acetaminophen with narcotics -- such as Vicodin and Percocet -- because of their risk for overdose and for severe liver injury.
A government advisory panel began voting Tuesday on recommendations for reducing the risk of serious liver injury associated with acetaminophen, found in over-the-counter drugs such as Tylenol and NyQuil.
The tobacco industry was once a well-funded behemoth in American politics, and while Big Tobacco's power is slowly eroding, its influence is far from gone.
Consumers should discontinue use of Zicam Cold Remedy nasal gel and related products because they can can permanently damage users' sense of smell, the government said Tuesday.
A bill that increases the power of the Food and Drug Administration to regulate the manufacturing, marketing and sale of tobacco products cleared the Senate on Thursday.
The U.S. Senate Thursday backed a plan giving the Food and Drug Administration power to regulate cigarettes and other tobacco products, allowing the agency to curb advertisements, require stronger package warnings and inspect manufacturers.
In 2008, according to documents obtained by Sports Illustrated through a Freedom of Information Act request, the FDA received a variety of adverse health event reports from consumers using supplements. The bad reactions range from a man whose heart rate was stuck at 147 beats per minute (p. 39, PDF 1) for two hours after he took a product called Fireball Liquifusion, to a woman who experienced shortness of breath and shaky hands after using an energy and weight loss product that was sold to her out of the back room of a supplement store and that illegally contained ephedrine (p. 41, PDF 1). As noted in the FDA report, "this product appears to be readily available on the Internet."
Reports of young children developing premature or inappropriate sex characteristics have prompted the U.S. Food and Drug Administration to require a boxed label warning on two testosterone gel products.
Several associations in the alternative medicine industry have joined forces to warn against non-conventional remedies that claim to cure or prevent swine flu.
Hydroxycut products, popular dietary supplements used for weight loss, have been linked to liver damage and are being recalled, the U.S. Food and Drug Administration said Friday.
Over-the-counter painkillers and fever reducers will now carry new labels warning consumers of the potential risks of liver damage and internal bleeding associated with the drugs, according to a final ruling Tuesday by the Food and Drug Administration.
FDA style regulation: Imagine this speech from a pharmaceutical marketing manager. "This new drug is designed to work well, but we haven't tried it out yet on real people. Of course, there could be terrible side effects, but wait and see. One thing's for sure, though. There's money in it for our company."
Seventeen-year-old women should be able to buy the "morning-after pill" without a prescription within a few weeks, a government spokesman said Thursday.
A form of liquid morphine used by terminally ill patients will remain on the market even though it is an "unapproved drug," according to a decision by the Food and Drug Administration.
A California company has widened its recall of pistachios to raw nuts and all roasted nuts produced in 2008 after health inspectors raised concerns of salmonella contamination, the Food and Drug Administration said Monday.
One of the cornerstones of Washington's omnibus stimulus plan is $19 billion in spending on improved information technology systems in hospitals and other health facilities throughout the U.S.
The House of Representatives passed a bill Thursday that would give the Food and Drug Administration the authority to regulate the advertising and sale of tobacco products in the United States.
One of the cornerstones of Washington's omnibus stimulus plan is $19 billion in spending on improved information technology systems in hospitals and other health facilities throughout the U.S.
Seeking to remove unapproved drugs from the marketplace, the Food and Drug Administration on Tuesday ordered nine companies to stop manufacturing narcotics whose therapeutic claims have not been proved.
A California food processing plant is voluntarily recalling up to 1 million pounds of roasted pistachio products that may have been contaminated with salmonella, the Food and Drug Administration announced Monday.
The Food and Drug Administration said Wednesday that it has stopped reviewing drug applications from an India-based pharmaceutical plant, alleging that officials there falsified data and test results in applications, some of which the agency has already approved.
The government is warning that taking the psoriasis drug Raptiva could result in serious brain infection and even death.
The Georgia company whose peanut products have been blamed for a nationwide salmonella outbreak shipped some products even though they had tested positive for the bacteria and no other tests indicated they were safe, the Food and Drug Administration said Friday.
Greek physician Hippocrates was the first to use the words "carcinos" and "carcinoma" in 400 BC to describe tumors, which led to the term "cancer" being coined.
In the wake of the salmonella outbreak that has sickened more than 500 people and been linked to eight deaths, peanut butter makers have moved to separate themselves from the company that produced the tainted product.
The maker of peanut butter linked to a nationwide outbreak of salmonella shipped tainted product it knew had tested positive for the bacteria, the Food and Drug Administration said Wednesday.
PetSmart is recalling seven of its Grreat Choice dog biscuit products because they contain peanut products made by a company that has been linked to a salmonella outbreak in 43 states and Canada, the Food and Drug Administration said Wednesday.
The Food and Drug Administration announced formal guidelines Thursday that will regulate the production of genetically engineered (GE) animals.
Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."
Soon, the food you put on your dinner table may be from cloned animals and chances are, you won't even know it. The Food and Drug Administration announced in January 2008 that's it OK to sell meat and milk from cloned cattle, pigs and goats. What does this mean to the consumer? Is cloned meat safe? How does it differ from regular animal products?
After first saying that they could not determine a threshold for the safe amount of certain toxic chemicals in infant formula, Food and Drug Administration officials said Friday that trace amounts are safe.
Several samples of infant formula have tested positive for trace amounts of the toxic contaminant melamine or a related compound, the Food and Drug Administration said Thursday.
Some research suggests that the risk of leg and lung blood clots may be higher for women who use the birth-control patch instead of the pill. The Food and Drug Administration said it updated the label on the Ortho Evra birth-control patch in January 2008 to reflect the results of one study that found women using the patch faced twice the risk of clots, compared with women on the pill. But a second study found no difference in risk between the two forms of birth control.
A single sample of infant formula has tested positive for trace amounts of the toxic contaminant melamine, the Food and Drug Administration said Tuesday.
Federal authorities said Thursday they have seized some of an Ohio company's supplies of contaminated blood thinner containing material from China.
Postmenopausal women who have lost interest in sex may be able to bring their libidos back to life with a testosterone patch, according to new research published this week in The New England Journal of Medicine.
An FDA panel revives concerns about the safety of plastic in baby bottles
A panel of experts accused the Food and Drug Administration of creating "a false sense of security" with its assessment that a compound used to make food and beverage containers poses no immediate health risks.
Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drug makers, congressional investigators said
The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world
In a new report, the GAO blows the whistle on Food and Drug Administration's inability to protect us from our produce
The government closed U.S. borders Tuesday to more than 30 generic drugs -- including popular antibiotics and cholesterol medicines -- made by India's biggest pharmaceutical company, citing poor quality in two of its factories
With scientists at odds over the safety of a chemical found in plastic baby bottles, metal cans and other food packaging, consumers got minimal guidance Tuesday about how to protect themselves
Cancer patients will soon be able to use a medication patch to ease the debilitating nausea that often accompanies chemotherapy
A new study links exposure to bisphenol A, a chemical commonly found in plastic, with higher rates of heart disease and diabetes. The FDA has declared the compound safe. What gives?
The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific change
The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients
In an effort to improve communication with doctors and patients on prescription drug safety, the government Friday began posting a list of medications under investigation for potential problems
Consumers worried about salad safety may soon be able to buy fresh spinach and iceberg lettuce zapped with just enough radiation to kill E. coli and a few other germs
A salmonella outbreak in the United States and Canada has been linked to irrigation water and serrano peppers at a Mexican farm, the federal Food and Drug Administration said Wednesday.
The salmonella strain linked to a nationwide outbreak has been found in irrigation water and a serrano pepper at a Mexican farm, federal health officials said Wednesday
Only Mexican-grown raw jalapeños and raw serrano peppers have been linked to the salmonella outbreak, a spokesman for the Food and Drug Administration said Friday.
The government is narrowing its warning to hot pepper lovers, saying only Mexican-grown jalapenos now are linked to the nationwide salmonella outbreak -- clearing the U.S. crop
Investigators had a "significant break" in tracking the salmonella outbreak when they found the bacteria on a jalapeño pepper imported from Mexico at a Texas food supplier, the Food and Drug Administration announced Monday.
One of the worst outbreaks of foodborne illness in the US is teaching the food industry to be cautious of its success
Web-based testing is a hot industry, but some question whether consumers know how to use the information
Government inspectors have found the same salmonella strain responsible for a nationwide food-poisoning outbreak in a Mexican-grown jalapeÑo in a Texas plant
Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada.
The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak -- while not over -- may finally be slowing
How, exactly, did Wal-Mart become the new Food and Drug Administration?
The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendonitis.
Starting Monday, FDA inspectors will expand the salmonella search beyond tomatoes to include cilantro, jalapeño and serrano peppers, scallions and onions.
Wireless systems used by many hospitals to keep track of medical equipment can cause potentially deadly breakdowns in lifesaving devices such as breathing and dialysis machines
Too big of a temperature difference can make a tomato literally suck water inside the fruit through the scar where its stem used to be. If salmonella happens to be lurking on the skin, that's one way it can penetrate
There may be a break in the salmonella case: Food and Drug Administration inspectors headed for farms in Florida and Mexico on Friday, as new clues emerge to the possible source of salmonella-tainted tomatoes
A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration
The number of cases of sickness caused by tomatoes has risen in recent days; 383 people have been infected with a rare form of salmonella since April in 30 states and the District of Columbia, federal health officials said Wednesday.
The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer
One part of Mexico -- Baja California -- has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people
What Americans need to know about the outbreak of salmonella in their salad fruit of choice, and why it's so hard to determine the source of all the trouble
A consumer advocacy group called on the FDA to ban the use of eight artificial colorings in food because they may cause hyperactivity and behavior problems in some children
Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year's end -- and the government is urging patients not to wait until the last minute to switch to newer alternatives
Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths
The widow of a man who died after receiving contaminated heparin told a congressional subcommittee Tuesday "we have a false sense of security" in a land where people expect to be protected and safe
A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials
New tests suggest how a contaminant in heparin -- a blood thinner -- may be connected to dozens of deaths, FDA officials said Monday.
The Food and Drug Administration looks like it's bowing to the inevitable this week and drawing the blueprint for the first-ever human experiments with human embryonic stem cells.
He's no Julia Child, but Honduran President Manuel Zelaya showed Tuesday he can attack a cantaloupe and U.S. government claims in a single motion.
Eight members of the military who objected to getting a mandatory anthrax vaccination lost another round in federal court Friday.
A flood of drug safety warnings from the Food and Drug Administration may have physicians and patients suffocating from information saturation. Experts say there are too many red flags for them to pay attention.
The FDA has approved the sale of cloned meat and milk products in the US, but those items won't be specially labeled. Would you want to know how your ribeye was reproduced?
Smaller biotechnology companies are ready to take the lead away from big pharma in developing antibiotics that can take on a new generation of deadly "superbugs."
U.S. health officials said Wednesday they have not inspected a Chinese factory that may be a source of problems with a blood thinner linked to allergic reactions and four deaths, but plan an inspection as soon as possible
The active ingredient in a blood-thinning medication made by Baxter International Inc, which is being blamed for causing allergic reactions, was reportedly manufactured at a Chinese facility that was never inspected by the the U.S. Food and Drug Administration, according to a report in The Wall Street Journal.
The Food and Drug Administration has fined the Red Cross an additional $4.6 million for the distribution of "unsuitable blood products," bringing penalties against the organization to more than $19 million in recent years
It's looking like the number of drugs that got an OK from the Food and Drug Administration plunged in 2007, even as Big Pharma faces a slew of patent expirations.
When toddler Olivia Cavalli came down when the sniffles, her mother, Sarah, would quickly turn to the medicine cabinet.
The U.S. Food and Drug Administration warned parents Thursday not to give over-the-counter cold medicine to children under age 2 because of "serious and potentially life-threatening side effects."
Patients and doctors alike may have received some fuzzy truth about the effectiveness of antidepressant medication.
Food from healthy clones of cattle, swine and goats is as safe as food from non-cloned animals, the Food and Drug Administration said in a report released Tuesday.
You are what you eat -- and what you don't eat. And so if you are like many of us, not quite hitting the entire food pyramid, you might be trying to outwit your body by giving it nutritional supplements to make up for the sins of food-group omissions.
Mothers sit propped against pillows and gym mats at the "Real Birth" baby clinic in New York City. It's a sea of unwashed hair, women of various ages and professions, complicit smiles and apologies for not looking more put together. The diverse women share a common drive: the desire to breast-feed their babies. They believe it's the best nutrition, but they have difficulty, for reasons ranging from low milk production to adopted babies to problems with some babies latching on.
Led by the emergency contraceptive Plan B, a new class of drugs called "behind-the-counter" is entering the FDA's spotlight.
Federal drug approvals have plummeted by nearly a third in 2007, according to a report issued Thursday that is likely to fuel complaints that regulators are stymieing efforts to get new treatments on the market.
The FDA just can't win. After years of public ridicule and congressional scrutiny, the Food and Drug Administration is taking a tougher stance against drugmakers in its review of new medicines. That new cautiousness, however, rankles its most powerful constituents: Big Pharma CEOs who charge that the agency is standing in the way of new medicines - and progress.
An advisory commission created in response to concerns about recalls of dangerous toothpaste, dog food and toys will recommend to President Bush that the Food and Drug Administration be empowered to order mandatory recalls of products deemed a risk to consumers, an administration official said Monday.
Over-the-counter cold and cough medicines don't work for children under age 6, and giving the common medicine to young children cannot be recommended, a Food and Drug Administration advisory committee said in October.
In a panel meeting on Friday FDA advisers decided that children under the age of 6 should not be using cold and cough medicines because they have not been proven to be effective or safe.
Men taking any of the three erectile dysfunction drugs - Viagra, Levitra or Cialis - or the blood pressure medication Revatio may be at increased risk for sudden hearing loss, prompting Food and Drug Administration officials to require label changes by the manufacturer.
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