Food and Drug Administration News

Date Posted
Article Title
11/18/2008
Cancer Drug Ups Risk of Clots in Veins

Those on Avastin faced 33% increased risk of dangerous side effect

11/18/2008
Wrinkle Fillers Need Better Label Warnings: FDA Panel

Reports of allergic reactions, other problems have surfaced with these products, experts say

11/12/2008
Early Onset Approved for ADHD Drug

30-minute onset of action for Focalin XR

11/10/2008
High Temps Degrade Contact Lens Solution: Study

ReNu with MoistureLoc was tied to eye infection outbreak in U.S.

11/5/2008
Testosterone Patch Restores Libido in Postmenopausal Women

But, the male hormone therapy may cause unwanted hair growth, study finds

11/3/2008
Study Sheds Light on Painkillers' Heart Risk

Cox-2 drugs, like Celebrex, less safe than Cox-1 drugs, like naproxen, study says

11/1/2008
FDA Faulted for Stance on Chemical in Plastics

BPA widely used in baby bottles, food containers; has been linked to diabetes, heart disease

10/31/2008
FDA Warns of Dangers of Mexican Vanilla

Agency says it contains coumarin, which is related to ingredient in blood thinners

10/31/2008
Decorative Halloween Eye Lenses May Pose Serious Risks

Without doctor's advice, cat's-eyes, color contacts boost odds of bacterial infection

10/30/2008
Consumer Group Seeks FDA Ban on Avandia

Public Citizen cites liver failure deaths, other risks of adverse events for diabetes drug

10/28/2008
Bayer Marketing Two Unapproved Aspirin Products: FDA

Warning letters issued for Bayer Heart Advantage, Bayer Women's Low Dose Aspirin + Calcium

10/27/2008
Osteoporosis Meds Linked to Heart Problem

Bisphosphonates may up rate of serious atrial fibrillation, review finds

10/21/2008
One-Quarter of Biologic Drugs Have Had Safety Issues

International analysis finds 11% issued 'black box' warnings by FDA

10/17/2008
Ontak Approved to Treat T-Cell Lymphoma

Targets specific receptor on cancer cells

10/17/2008
Aspirin Doesn't Prevent First Heart Attack, Stroke

Study contradicts current recommendations; expert suggests change

10/13/2008
NeuroStar Depression Therapy Cleared

Targets nerve cells with magnetic pulses

10/10/2008
Is Human Growth Hormone a Key to Longevity?

Current evidence suggests its anti-aging benefits are marginal

10/10/2008
Kogenate FS Prevents Joint Damage in Young Hemophiliacs

Hemophilia A affects about 15,000 in the U.S.

10/9/2008
25% of Teen Girls Vaccinated for HPV

It's a good start for new vaccine, CDC says

10/9/2008
Rapaflo Approved for Enlarged Prostate

The leading reason men visit urologists

10/7/2008
Drug Companies Say No Cold Meds for Kids Under 4

FDA supports industry's voluntary action to change labeling as agency continues to assess whether products are safe for the youngest set

10/6/2008
Free Prescription Drug Samples Pose Risk to Kids

Few actually go to needy children, and newer meds lack safety profile, study finds

10/3/2008
FDA Rules How Much Melamine Is Too Much

In wake of China food scare, agency says any amount is too much for infants

10/2/2008
FDA Wants More Time to Study Cold Meds for Kids

More data needed on whether OTC remedies are safe, agency official tells public meeting

9/29/2008
'Superbug' Test Detects MRSA Faster

Existing diagnostics can take up to 3 days

9/29/2008
FDA Faulted for Lack of Produce Oversight

Congressional report cites insufficient funding and resources

9/29/2008
Scams and Shams That Prey on Cancer Patients

In some cases, unproven 'therapies' can be dangerous, experts say

9/26/2008
Anemia Drugs Linked to Stroke Study Deaths: FDA

Procrit, Aranesp already bear warning labels due to cancer concerns, experts note

9/23/2008
FDA Goes After Unapproved Eye Washes, Skin Ointments

Salt solutions, topicals containing papain face seizure after adverse events reported

9/23/2008
Many Trial Reports on FDA-Approved Drugs Go Unpublished

Selective reporting may color record of comparisons to other meds, study says

9/19/2008
FDA Proposes Regulations for Genetically Engineered Animals

Producers must provide safety and efficacy data before market approval

9/19/2008
Group Works to Streamline Cancer Therapy Approvals

6-point flow chart seeks to clarify most productive research lines for FDA consideration

9/18/2008
9/18/2008
Drug Combo Fights Recurrent Ovarian Cancer Cell Growth

Researchers say trabectedin showed promise in Phase III trial, hope for FDA approval

9/16/2008
FDA Bars Generic Drugs From Indian Company

Poor manufacturing conditions at 2 plants to blame, agency says

9/15/2008
9/15/2008
Gardasil Approved for Additional Uses

To help protect women against two more cancers

9/5/2008
FDA to List Drugs Under Review for Safety Issues

But officials say patients taking meds on Web site shouldn't overreact or stop taking them

9/4/2008
FDA Demands Tougher Warnings on Immunosuppressive Drugs

Officials want stronger labeling about fungal infection risk

8/28/2008
Salmonella Outbreak Over, U.S. Says

FDA lifts advisory against eating raw Mexican jalapeno and serrano peppers

8/27/2008
New Test Identifies Heart Transplant Rejection

Monitors gene activity in white blood cells

8/27/2008
4 More Deaths Reported Among Byetta Patients

Brings death toll to 6 associated with diabetes drug; exact cause unknown

8/22/2008
Bone Marrow Treatment Approved for Rare Bleeding Disorder

Stimulates marrow to compensate for low platelet count

8/21/2008
Tobacco Marketing Promotes Youth Cigarette Use

But landmark report also says mass media anti-tobacco campaigns work, too

8/15/2008
First Treatment Sanctioned for Chorea in Huntington's Patients

The involuntary jerky movements that accompany the disease

8/12/2008
Viread Approved for Hepatitis B

Already sanctioned to treat HIV

8/8/2008
New Therapy Freezes Out Esophageal Cancers

Cryoablation attractive option for older patients with other medical issues, team says

8/5/2008
FDA OKs Flu Vaccines for 2008-09 Season

The hope is they will be a better match than last year's shots

8/4/2008
Injected Drug Approved for High Blood Pressure

When oral therapy isn't feasible

8/4/2008
OTC Cold Medicines Sending Children to Emergency Rooms

The FDA recently advised that kids under 2 not use these products