FDA

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School Breaks With Feds Over Gay Rights

San Jose State stops blood drives, cites FDA rule banning gays

(Newser) - Saying a federal directive aimed at keeping gay men from donating blood violates school non-discrimination policies, the president of a California university is stopping blood drives on campus, the San Jose Mercury News reports. In a campus-wide email, San Jose State University president Don Kassing says a ban on such...

Abortion Pill Maker in Tainted Drug Scandal

Paralyzing meds made by Chinese firm that sells all RU-486 in US

(Newser) - A Chinese pharmaceutical giant which exports the abortion pill RU-486 to the US is accused of producing tainted cancer medication and of attempting a cover-up.  Shanghai Hualian's tainted drugs left 200 Chinese leukemia patients hospitalized, some paralyzed, reports the New York Times. There's no indication US shipments of RU-486...

FDA Mandates Suicide Risk Assessment in Drug Trials

Danger doesn't lie only in antidepressants

(Newser) - The Food and Drug Administration is now requiring drug companies to monitor suicide warning signs in clinical trials for experimental drugs, the New York Times reports. In the wake of studies showing that antidepressants might increase the risk of self-harm in children and teens, the agency is showing an awareness...

High Mercury Levels Found in Tuna Sushi

FDA reconsidering warnings on seafood mercury

(Newser) - A quarter of tuna sushi sampled in New York contained mercury levels so high that the FDA could take legal action to ban the fish from the market, reports the New York Times.  Although the sushi was collected in New York City, experts believe samples elsewhere would be similar....

Ditch Cold Meds for Tots: FDA
Ditch Cold Meds for Tots: FDA
Jan 17, 2008 6:04 AM CST

Ditch Cold Meds for Tots: FDA

Government to officially warn against dosing children under 2

(Newser) - Although cold and cough medicine manufacturers pulled their baby and toddler lines off the shelves in October, the FDA is issuing an official advisory today to warn parents of the risk of giving any such remedies to children under 2. The government worries that uninformed parents are simply dosing their...

Antidepressant Studies Distort Drugs' Usefulness

New study says negative reports often go unpublished

(Newser) - Roughly half of the medical studies involving antidepressants that found little or no effect on patients have gone unpublished or had their findings mischaracterized as positive, a new study reveals. The emphasis on publishing only studies with glowing reviews gives patients and doctors a false sense of the effectiveness of...

FDA: Send in the Clones
FDA: Send in the Clones
Jan 15, 2008 1:06 PM CST

FDA: Send in the Clones

Agency finds no health effects, loss of nutritional value

(Newser) - Clones are just as safe to eat as any other animal, concludes a much-awaited, much-debated report from the FDA. Cloned animals studied were found to be as healthy as their normal counterparts, and their meat contained equal levels of nutrients, the Washington Post reports. The 968-page document provides mountains of...

No Right to Drugs for Dying
No Right to Drugs for Dying
Jan 15, 2008 3:30 AM CST

No Right to Drugs for Dying

Supreme Court declines to hear plea for experimental drugs

(Newser) - The Supreme Court has declined to hear what could have been a landmark case on whether terminally ill patients should be given access to experimental drugs not yet approved by the Food and Drug Administration. The decision lets stand a lower court ruling that the terminally ill have no special...

New Drug Stirs Debate Over Disease's Existence

Widely advertised Lyrica treats fibromyalgia, but some docs raise red flags

(Newser) - The first drug approved by the FDA to treat fibromyalgia is raising questions, but not the typical ones about whether the medication works. They're questions about whether the disease even exists. Lyrica sales are up and climbing, but critics say giving a name to the chronic pain that characterizes fibromyalgia...

Beefed-Up R&amp;D Slows Drug Approval
Beefed-Up R&D Slows Drug Approval
Jan 8, 2008 5:45 PM CST

Beefed-Up R&D Slows Drug Approval

Just 19 new meds cleared FDA in 2007

(Newser) - The FDA approved only 19 new drugs in 2007, the lowest total in 24 years. Bloomberg takes a look at the reasons. Some drug companies accuse the FDA of setting the bar higher for drug approvals, a charge the agency denies. Many, however, say the issue lies with big pharma...

Shots Could End Coke Addiction
Shots Could End Coke Addiction
Jan 2, 2008 8:02 AM CST

Shots Could End Coke Addiction

Vaccine stops drug from producing a high

(Newser) - Scientists have developed a potential vaccine against cocaine addiction and have asked the federal Food and Drug Administration to greenlight large-scale clinical trials. The injections of modified cocaine work by stimulating the immune system to attack cocaine when it's ingested, preventing the drug from producing a high, reports the Houston ...

Desperate Cancer Victims Turn to Do-it-Yourself Cures

Americans create risky cancer cocktails they hope will help

(Newser) - Desperate for a cure, and fed up with waiting for a federal Food and Drug Administration they say takes too long to approve drugs, some ill Americans are concocting cancer medicine "cocktails"—many of which haven’t been approved or tested—they hope will save their lives, reports...

FDA Panel Rejects Breast Cancer Drug

Uncertainties on risk sink bid to expand uses for Avastin

(Newser) - An FDA panel rejected a drug to treat advanced breast cancer by 5-to-4 vote, the Wall Street Journal reports. The drug Avastin is already used to treat colon and lung cancer, but the panel said it did not have sufficient data to weigh the risks and benefits of using the...

Honey Works on Kids' Coughs
Honey Works on Kids' Coughs
Dec 4, 2007 7:07 AM CST

Honey Works on Kids' Coughs

Study says it soothes throat, helps children sleep

(Newser) - Parents looking for an alternative to cold medicines for their young kids might consider a sweet solution—honey. A new study suggests that a commonly available dark variety soothes children's coughs and helps them sleep better, the Houston Chronicle reports.  The study comes in the wake of the FDA's...

3 Stars Means It's Healthy, Right?
3 Stars Means It's Healthy, Right?
Dec 1, 2007 10:01 PM CST

3 Stars Means It's Healthy, Right?

Experts fear that new health ratings systems may befuddle shoppers

(Newser) - Stars, numbers, and letter grades are coming to grocery stores near you, the New York Times reports—but experts fear that these health ratings may befuddle shoppers with conflicting information. Consumer advocates are studying three new food ranking systems, while the FDA, approached by a nutrition group, is soliciting ideas...

Salt May Get an FDA Shakedown
Salt May Get an FDA Shakedown
Nov 29, 2007 12:05 PM CST

Salt May Get an FDA Shakedown

Increased regs likely on concerns about overconsumption, health effects

(Newser) - As the White House readies a national campaign against obesity, the FDA today will consider whether to reclassify one of the biggest dietary concerns of all: salt. The American Medical Association says that for Americans, who each day consume around 2,000 milligrams more than recommended, cutting salt intake by...

Tamiflu Will Carry Stronger Warning Labels

Maker will beef up language on possible psychiatric side effects

(Newser) - The maker of flu drug Tamiflu said today it will accept recommendations by a government panel that it revise printed warnings about the medication's side effects. Labels already warn of possible psychiatric reactions, but the panel recommended noting that some people have died, the AP reports. Drugmaker Roche says flu...

Lack of Info Plagues Docs Treating Kids

Limited funding for research on meds puts children at risk

(Newser) - A dearth of information on the effects of prescription drugs on children is putting millions of kids at risk, the Washington Post reports. Two-thirds of the medications prescribed to kids haven't been tested on them, and those that have been tested often produce unexpected results: A migraine drug that works...

35.5 Million Americans Going Hungry
35.5 Million Americans Going Hungry
Nov 15, 2007 1:50 AM CST

35.5 Million Americans Going Hungry

Rising costs, stagnant wages threaten even worse news next year

(Newser) - US programs failed to make a dent in the number of Americans going hungry last year, and activists warned that rising costs and stagnant wages threaten to increase the army of citizens struggling to put food on the table. Nearly 13 percent of households—35.5 million Americans, with 12....

Diabetes Drug Given Strictest Warning Label

FDA's 'black box' adds risk of heart attack to concerns on Avandia

(Newser) - The FDA has applied its harshest warning to the diabetes drug Avandia, declaring the product potentially increases risk of heart attacks. Now marked with a “black box” warning, GlaxoSmithKline’s drug will stay on the market pending a continuing “safety assessment,” the Wall Street Journal reports; FDA...

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