Food and Drug Administration News

Date Posted
Article Title
2/21/2007
ADHD Drugs Need Better Warnings on Heart, Psychiatric Risks: FDA

All meds must now come with patient guideline inserts, agency says

2/13/2007
First Recombinant DNA-Based Suture Approved

Polymer material made from genetically modified bacteria

2/12/2007
FDA Limits Use of Controversial Antibiotic

Ketek, which has been linked to liver damage, also gets updated 'black box' warning

2/8/2007
FDA OKs 1st Over-the-Counter Weight-Loss Drug

Alli only works when used with a diet and exercise program

2/7/2007
Orlistat Approved for Over-the-Counter Sale

A lower-dose version of adult weight-loss aid

2/6/2007
Heart Surgery Drug May Boost Death Risk

Aprotinin had already been linked to kidney and heart failure, researchers note

2/6/2007
FDA Approves Gene-Based Breast Cancer Test

But questions remain about the exam's accuracy

2/6/2007
Children's Drug Trial Program Gives Boost to Medicine, Profits

Federal initiative helps kids by improving drug makers' bottom line, study finds

2/6/2007
Some Contraceptives May Cause Blood Clots: Petition

Public Citizen wants pills containing the synthetic hormone desogestrel banned

2/6/2007
New Test Predicts Chances of Breast Cancer Return

Based on a woman's genetic profile

2/2/2007
Alphanate Approved for Clotting Disorder

For people with von Willebrand disease who require surgery

1/31/2007
FDA to Monitor Post-Market Drug Safety

Pilot project among proposals agency lays out in response to growing criticism of its operations

1/29/2007
Study Blasts TV Drug Ads

There's too much emotion, not enough information for consumers, experts say

1/24/2007
New Drug Fights Deadly Fungal Infections

Noxafil recently gained FDA approval and is already in widespread use

1/17/2007
Lialda Approved for Ulcerative Colitis

To induce remission of inflammatory bowel disease

1/11/2007
FDA Seeks Higher Fees From Drug Industry

Says they're needed to improve safety and oversight; critics cite possible conflict of interest

1/11/2007
Refrigerated Version of Inhaled Flu Vaccine Approved

Makes it easier to keep FluMist in schools and pharmacies

1/11/2007
U.S. Approves First Drug for Obese Dogs

Not a remedy for overweight people, FDA warns

1/10/2007
FDA Alerts Pharmaceutical Companies to Potentially Faulty Testing

Letters sent involve more than 1,100 generic and brand-name drugs

12/29/2006
Rising Number of Uninsured Tops Health News for 2006

Worries about food safety, antidepressants and stents also made headlines

12/28/2006
FDA Calls Food From Cloned Animals Safe

Critics disagree; public has 90 days to comment

12/28/2006
Cosmetic Wrinkle Filler Approved

Radiesse treats frown lines and other facial folds

12/27/2006
Generic Anti-Nausea Drug Approved

Zofran prescribed after surgery or chemotherapy

12/20/2006
Colazal Sanctioned for Pediatric Colitis

Previously approved for adults

12/20/2006
Invega Approved for Schizophrenia

But drug shouldn't be given to some elderly patients

12/20/2006
FDA Calls for Tougher Warnings on OTC Painkillers

Products such as aspirin, Tylenol and Motrin would be affected

12/19/2006
Generic Proscar Approved

Treats enlarged prostate

12/16/2006
FDA OKs Celebrex for Kids With Arthritis

Says benefits outweigh potential risks, but Pfizer will have to keep a long-term registry to evaluate safety issues

12/16/2006
FDA Panel Hits Antibiotic For Bronchitis, Sinusitis

Ketek can be used for pneumonia with tougher warning label, but is risky for lesser conditions, advisers recommend

12/15/2006
FDA Strengthens Warning on Heart Surgery Drug

Cardiovascular, kidney risks mean Trasylol should only be used in special circumstances

12/15/2006
U.S. Panels Begin Hearings on Antibiotic's Safety

Company defends Ketek while FDA defends 2004 approval of controversial drug

12/14/2006
Iceberg Lettuce Seen as Taco Bell E. coli Source

U.S. health officials declare outbreak over, but investigation continues

12/14/2006
Generic Wellbutrin XL Approved

Extended-release antidepressant sanctioned for major depressive disorder

12/14/2006
Avastin Plus Chemo Benefits Lung-Cancer Patients

Treatment extended survival by 2 months, a small but significant gain, researchers say

12/14/2006
FDA Panel Urges Changes to Antidepressant Labeling

'Black box' warning on suicide risk may be extended beyond children

12/12/2006
Taco Bell E. coli Outbreak Cause Still a Mystery

U.S. health officials say green onions tested negative

12/9/2006
Victim Count in Taco Bell E. coli Outbreak Still Rising

Confirmed cases now spread across 6 states; source of outbreak still unclear, CDC says

12/8/2006
Drug-Coated Stents Don't Boost Death Risk, U.S. Advisers Say

But the devices may be the cause of blood clots, FDA panel notes

12/6/2006
Gleevec Continues to Beat Blood Cancer

89 percent of CML patients have survived for 5 years, study finds

12/6/2006
Drug-Coated Stents Create Clot Risk

While they offer benefits, they may not be appropriate for all heart patients, FDA says

11/30/2006
Don't Expect Big Push for Celebrex for Juvenile Arthritis

FDA panel recommends its use, but other treatment options exist, experts say

11/30/2006
FDA Panel Backs Celebrex for Kids With Arthritis

Says benefits outweigh potential risks to those with juvenile rheumatoid arthritis

11/17/2006
FDA OKs Return of Silicone Breast Implants

The decision requires the 2 manufacturers to continue studies of the devices' safety

11/14/2006
11/9/2006
11 Million Bottles of Acetaminophen Recalled

Bits of wire discovered in drug sold at retailers such as Wal-Mart, CVS, Costco

11/1/2006
Generic Metronidazole Approved

Antibiotic treats overgrowth of vaginal bacteria

10/27/2006
Americans Fall Prey to Weight-Loss Supplement 'Hype'

Many mistakenly believe these products are tested and safe, survey finds

10/26/2006
Wild Boar May Have Caused Tainted Spinach Outbreak

Investigators probe whether animals carried E. coli to produce fields

10/25/2006
Tyzeka Approved to Treat Chronic Hepatitis B

But it isn't a cure for the dangerous liver infection

10/23/2006
Omnaris Approved for Hay Fever

Nasal spray suppresses body's immune response