FDA

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FDA Flags Chinese Seafood
FDA Flags Chinese Seafood

FDA Flags Chinese Seafood

Officials put the brakes on imports of species tainted with unapproved drugs

(Newser) - Add farmed seafood to the list of unsafe goods imported from China. The FDA will detain three varieties of fish as well as shrimp and eel, the agency said today, after tests revealed the presence of antibiotics and antifungals that aren't approved in the US for use in aquaculture. The...

Colgate Cautions Against Fake Toothpaste

Counterfeit dentifrice may contain toxic chemical, company says

(Newser) - Colgate alerted the public today that counterfeit toothpaste bearing its brand name and possibly containing a deadly chemical has turned up in discount stores in four Northeast states. The phony products' packaging is riddled with misspellings and gives the manufacturing location as South Africa, where the company doesn't make toothpaste....

FDA Advisory Panel Rejects Weight-Loss Drug

Possible side effects send Acomplia to the sidelines

(Newser) - Accomplia, a weight-loss drug marketed in 18 other countries, failed to win approval from an FDA advisory board yesterday. The 14-member panel of outside experts ruled unanimously that manufacturer Sanofi-Aventis had not dispelled concerns about the safety of the drug, whose potential side effects include suicidal thoughts, anxiety, and depression.

Americans Go Abroad, Online for New Diet Pill

Hung up in FDA approval process, pill's already scoring big

(Newser) - The weight loss drug Acomplia is stuck in FDA limbo, but that isn't stopping Americans from ordering it off the Internet or buying it in Europe, where it's legal. If the government rules that its lowering of weight and cholesterol balances out the possible side effects, including suicide and depression,...

Controversy Rages Over Diabetes Drug's Heart Risks

FDA official says superiors ordered her to back off serious warning

(Newser) - Troubling questions about the diabetes drug Avandia persisted yesterday as an FDA official revealed that she was barred from recommending a critical warning about the medication, the Times reports. In the run-up to congressional hearings that began today, manufacturer GlaxoSmithKline rushed to disseminate interim clinical findings in hopes of blunting...

Conservatives Wield FDA Data on HPV Vaccine

Cite health risks in opposing vaccination of teenage girls

(Newser) - A group of religious conservatives has marshalled unreleased FDA data as a weapon in the battle against  Gardasil, the new cervical cancer vaccine. The data indicates health problems in women taking the vaccine, but  drugmaker Merck and the FDA both insist that the negative effects are probably unrelated to the...

FDA Approves No-Period Birth Control Pill

Drug from Wyeth includes 28 days of low-dose hormones

(Newser) - The FDA yesterday approved Lybrel, the birth control pill designed to stop women's periods for as long as they're on the medication, the AP reports. Unlike most other contraceptive pills, which consist of  21 daily doses of hormone treatments and 7 days of sugar pills, Lybrel contains 28 daily doses...

Drug Company Nemesis Strikes Again
Drug Company Nemesis
Strikes Again

Drug Company Nemesis Strikes Again

Crusading cardiologist took on Vioxx, now Avandia, for heart risks

(Newser) - The doctor who helped to raise concerns about the painkiller Vioxx is back—with the study released earlier this week linking the same company's popular diabetes drug, Avandia, to higher risk of heart attacks. The Wall Street Journal looks at 58-year-old cardiologist Steven Nissen's role in identifying and publicizing drug...

Diabetes Drug Ups Heart Risk
Diabetes
Drug Ups
Heart Risk

Diabetes Drug Ups Heart Risk

New study documents dangers of Avandia, but company nixes recall

(Newser) - A popular diabetes drug may increase heart attack risks, a study reported in the New England Journal of Medicine concludes. Patients who took Avandia, which treats Type 2 diabetes, were 43% more likely to have a heart attack than those who took a placebo, the Cleveland Clinic study found.

FDA Given New Muscle To Monitor Drugs

Senate bill requires continued scrutiny after approval

(Newser) - The Food and Drug Administration would be given sweeping new powers to order drug recalls, regulate advertising and mandate changes in labels under a bill passed by the Senate yesterday. The bill signals a fundamental shift in the FDA's role, the New York Times reports, requiring the agency to track...

Doctors Paid Millions To Use Anemia Drugs

Among the world's top-selling medicines, the FDA now says they may be unsafe

(Newser) - Doctors are paid millions of dollars by drug companies to give their patients anemia medicine which regulators now say may be dangerous. Spurred by competiton between several similar drugs, companies reward doctors with rebates, which allow them to make a significant profit, the New York Times reports.

Toxic Cough Syrup Causes Deaths in Panama

How a tailor in China passed glycol off as glycerin, and killed hundreds of children

(Newser) - American drugmakers are on the lookout this week for another in the growing list of potentially deadly Chinese exports. This time, it's diethylene glycol, a sweet-but-toxic chemical that masquerades as glycerin in common medications like cough syrup and that has already killed almost 400 people—many of them children—in...

Melamine Death Toll Passes 8,000 Pets

FDA says health risk for humans unlikely

(Newser) - More than 8,000 deaths of cats and dogs that may be linked to melamine-tainted food have been reported to the FDA in the two months since the pet food recall. The statistics come as the FDA tries to assure Americans that the tainted protein concentrates, also fed to hogs...

China Detains Pet Food Contaminator

Beijing cracks down on source of melamine-tainted gluten

(Newser) - Chinese authorities have jailed the head of a company accused of selling pet food makers  the melamine-contaminated gluten that's killed thousands of cats and dogs. The detention of Mao Lijun suggests Beijing is eager to cooperate with the FDA investigators currently on its turf, after initially disavowing any gluten sales...

FDA Names Food Safety Czar After Chicken Scare

Democrats seek other roads to effective FDA

(Newser) - The FDA appointed a food safety czar yesterday, as the news that 3 million chickens had been fed melamine-tainted feed exacerbated growing public anxiety about food safety. The FDA said the chickens weren't recalled because most of them would have been sold by now, and the melamine was too diluted...

FDA Knew About Food Dangers
FDA Knew About Food Dangers

FDA Knew About Food Dangers

Overwhelmed food-safety arm didn't follow up on peanut butter, spinach

(Newser) - The FDA knew for years about problems at the peanut butter plant and spinach farms that led to major disease outbreaks, but took minimal steps to redress them. The agency's food safety arm can't keep up with the explosion in the amount of food it is supposed to regulate, the ...

Stop Periods, Period?
Stop Periods, Period?

Stop Periods, Period?

They call it the curse, but women are mixed on birth control pill that stops menstruation

(Newser) - Women may complain about their periods, but would they miss them when they're gone? The FDA is set to approve an oral contraceptive that suppresses periods entirely, sparking controversy—including a documentary making the rounds of college campuses—over the meaning of menstruation.

FDA: Pet Food Poison Added Intentionally

Chinese may have used melamine to boost nutrition rating

(Newser) - The chemical which contaminated over 100 brands of pet food—with disastrous results for dog and cat lovers—may have been intentionally added by Chinese manufacturers in an effort to fudge nutrition ratings on their rice protein and wheat gluten. "That's still a theory, but it certainly seems to...

FDA Panel Passes First Cancer Vaccine
FDA Panel Passes First Cancer Vaccine

FDA Panel Passes First Cancer Vaccine

Prostate treatment recruits immune system to fight tumors

(Newser) - A cancer drug that's the first to harness the body's immune system to destroy tumors got a thumbs-up from  the FDA's advisory panel, the New York Times reports. If approved, Provenge, a prostate cancer treatment, would be the first of the "cancer vaccines"—experimental therapies that commandeer a...

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