Food and Drug Administration News

Date Posted
Article Title
12/14/2007
Decongestant in OTC Cold Remedies Effective: FDA Panel

Current evidence says 10-milligram dose works, but advisers urge study of higher doses

12/14/2007
FDA Advisers Reject Over-the-Counter Statin

They cite concerns that consumers wouldn't use the cholesterol-lowering drug Mevacor safely

12/13/2007
Kuvan Sanctioned for PKU

A rare genetic disorder

12/13/2007
Common Infant Vaccine Recalled

Hib shot shields against meningitis, pneumonia, but experts say recall shouldn't be health threat

12/11/2007
FDA Confirms No Heart Risk From Heartburn Drugs

Preliminary studies had suggested possible problems with Prilosec and Nexium

12/2/2007
Diabetes Drug Avandia Could Weaken Bones

Mouse study suggests it boosts production of bone-eroding cells

12/1/2007
FDA Report Says Nation's Health at Risk

The agency can't keep up with increasing demands, new technologies, subcommittee finds

11/29/2007
FDA Mulls Cutting Salt in Processed Foods

Experts agree Americans eat too much sodium, but differ on need for regulation

11/28/2007
FDA Panel Backs Tougher Warning on Asthma Drugs for Kids

Serevent and Advair need specific child warnings on side effects, pediatric panel says; action follows panel's recommendation to toughen label on flu drugs for kids.

11/20/2007
Abilify Approved as Additional Treatment for Major Depression

When antidepressant therapy isn't enough

11/19/2007
Nexavar Approved for Liver Cancer

Already sanctioned for advanced kidney cancer

11/16/2007
Diet Drug Rimonabant Tied to Depression, Anxiety

Experts caution against prescribing drug to patients who are already depressed

11/15/2007
FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales

'Behind-the-counter' dispensing would bypass doctors for some prescriptions

11/14/2007
Drug Helps Fight Late-Stage Colon Cancer in Some Patients

Cetuximab is first to extend survival for those resistant to chemotherapy, study says

11/14/2007
Avandia Label to Get Heart-Attack Warning

FDA takes action on diabetes drug although evidence is inconclusive

11/13/2007
FDA Mulls Direct Pharmacist-to-Patient Drug Sales

'Behind-the-counter' dispensing means doctor's prescriptions wouldn't be needed for certain meds

11/9/2007
Vioxx Settlement Puts Painkillers Back in the Spotlight

Cox-2 inhibitors not so bad if used wisely and in the right patients, experts say

11/9/2007
Zyrtec-D Approved Without Prescription

Drug combines popular antihistamine and nasal decongestant

11/8/2007
FDA Issues New Warnings for Anemia Drugs

ESAs can increase cancer growth, cause stroke and heart attacks, revised label warns

11/7/2007
FDA Seeks Food Recall Authority

New powers, endorsed by Bush, would affect both domestic and imported items, agency says

11/6/2007
11/5/2007
Trasylol Pulled From Worldwide Market

FDA says clotting drug poses increased death risk, while company says drug still has benefits

11/1/2007
Consumers Still Buying Risky Imported Drugs Online: FDA

Many seem to be doing so to avoid need for a prescription, agency says

10/31/2007
Combigan Drops Approved for Glaucoma

To treat pressure in the eye

10/29/2007
Tasigna Approved for Chronic Myeloid Leukemia

For people resistant to other therapies

10/22/2007
Meningitis Vaccine Gets Expanded Approval

Age range for Menactra now includes children 2 to 10

10/22/2007
Voltaren Gel Approved for Osteoarthritis

First topical prescription treatment for the joint disease

10/19/2007
FDA Panel Recommends Ban on Cold Medicines for Kids

Over-the-counter drugs are unsafe for children under 6, advisers say.

10/18/2007
FDA Panel Weighs Ban on Kids' Cold Medicines

Experts disagree on whether the medicines are safe for children under 6.

10/17/2007
Ixempra Approved for Breast Cancer

Targets protein that spurs growth of cancer cells

10/17/2007
New Drug Approved for Resistant HIV

Isentress inhibits enzyme that virus needs to multiply

10/16/2007
Defib Wire Warning Shouldn't Worry Most Users: Experts

Overall risk is low, but patients should consult with their doctors

10/15/2007
10/11/2007
Drug Makers Withdraw Cough, Cold Meds for Infants

Move comes as U.S. regulators scrutinize safety of products linked to dozens of deaths

10/10/2007
Generic Anti-Seizure Drug Approved

Oxcarbazepine sanctioned for people 4 and older

10/5/2007
10/4/2007
FDA Struggles to Keep Pace With Requests for Generics

More approvals are being recorded, but backlog continues to grow, officials say

9/29/2007
Diabetes Drugs Boost Heart Failure But Not Death

Experts split on what this means for those taking Avandia, Actos

9/29/2007
FDA Experts Urge Ban on Cold Medicines for Young Children

Safety review finds 123 deaths linked to the products since 1969

9/28/2007
FDA Approves New Flu Vaccine

That should ensure adequate supply for coming influenza season, officials say

9/28/2007
FDA Cracks Down on Unapproved Cough Medicines

Some 200 prescription drugs with hydrocodone could be involved

9/27/2007
Genes Might Predispose Antidepressant Users to Suicidal Thoughts

Someday, DNA tests might spot those most at risk, experts say

9/27/2007
Drug Industry Seeks Tests to Spot Side Effect Risks

7 pharmaceutical giants are pooling resources to develop gene-based screens

9/24/2007
No Link Between Anti-Nausea Drug, Heart Trouble

Current warning for droperidol unwarranted, study suggests

9/20/2007
Americans Confused About FDA and Drug Safety

Poll finds many mistrust the job the agency is doing

9/19/2007
Nasal Flu Vaccine Approved for Children Ages 2-5

FluMist already sanctioned for older kids and adults

9/18/2007
New Test Screens for Bacteria in Blood Platelets

Should benefit patients in need of transfusions

9/18/2007
Genetic Test Approved for Sensitivity to Blood Thinner

Some people who take Coumadin at higher risk of bleeding

9/14/2007
9/13/2007
Stopping Tysabri May Worsen MS

Small study finds increase in disease-linked brain lesions