FDA Consumer

A magazine of the Food and Drug Administration (FDA). Contains in-depth information on how to get healthy and stay health. Also offers information on current FDA activities such as food, drugs, animal drugs and food, cosmetics, and medical devices.

Articles from Vol. 36, No. 1, January-February

Accutane Risk Management Program Strengthened
The Food and Drug Administration has announced changes that strengthen a risk management program regarding pregnancy and a drug used to treat severe acne. Accutane (isotretinoin) is a drug approved to treat the most serious form of acne--a type that...
A Smile a Day May Help Keep Heart Disease Away. (Research Notebook)
Older men who see life's glass as being half full rather than half empty may be less likely to develop coronary heart disease, a new study indicates. Researchers ranked a group of more than 1,000 older men based on a scoring system that characterized...
A `Touch' of Diabetes? (the Last Word)
Sometimes, inside the health-care professions and health-care regulatory agencies, we hear the opinion that type 2 diabetes isn't that big a deal. It isn't cancer and it isn't AIDS. It's just a lifestyle disease. People shouldn't have let themselves...
Bringing Real Life to the Table: Patient Reps Help FDA Review Products
When Jim Anderson of La Plata, Md., became an FDA patient representative in 1997, he wasn't sure how much help he could be. In preparation for his first advisory committee meeting, the Food and Drug Administration sent him a new drug application (NDA)...
Diabetes: A Growing Public Health Concern
Either you have it or you don't. That's the message that the American Diabetes Association (ADA) is driving home to millions of people who believe they may be "borderline diabetic," or that their "sugar is just a bit high." Convenient phrases and...
FDA Approves First Biologic Treatment for Sepsis. (Updates)
The FDA has approved the first biologic treatment for the most serious forms of sepsis, a life-threatening illness caused by severe infection. The new treatment, called Xigris, is a genetically engineered version of a naturally occurring human protein,...
First Contraceptive Skin Patch. (Updates)
The FDA has approved Ortho Evra, the first skin patch for birth control. The prescription patch works by releasing hormones through the skin into the bloodstream to prevent pregnancy. The square patch, just under two inches wide, consists of three...
Foreign Drug Firm Pleads Guilty to Felony Charges. (Investigator's Reports)
A French pharmaceutical company has been fined $33 million for deliberately failing to disclose to Food and Drug Administration officials all of the locations where the antibiotic cefaclor was being manufactured. The monetary penalty is one of the...
Internet Vendors Warned about Unapproved Cipro. (Updates)
The FDA has notified Internet vendors of foreign-made ciprofloxacin that it is taking actions to halt potentially illicit sales of the antibiotic, which has been in increased demand since recent bioterrorist attacks in the United States. Ciprofloxacin...
Losing Weight: More Than Counting Calories
Americans are eating less fat, but getting fatter. We're putting on the pounds at an alarmingly rapid rate. And we're sacrificing our health for the sake of supersize portions, biggie drinks, and two-for-one value meals, obesity researchers say. ...
Observations
The after-effects of holiday parties, family gatherings, and too much food and drink are beginning to show on some of us. And health clubs nationwide are gearing up for the annual influx of new members determined to jog, lift and spin off those added...
Serve Up Lessons in Food Safety. (Teen Science Classes)
Every year 76 million Americans experience a foodborne illness; 325,000 are hospitalized and 5,000 die, according to the Centers for Disease Control and Prevention. In response to this public health concern, the Food and Drug Administration and the...
Study: Aspirin and Warfarin Equally Effective for Stroke Prevention. (Research Notebook)
Stroke is the third leading cause of death in the United States and the leading cause of serious, long-term disability. About 600,000 new strokes are reported in the United States annually and about 160,000 Americans die each year from stroke. A...
Study: Treatment Reduces Risk of Heart Attack by 70 Percent. (Research Notebook)
Cardiovascular disease is the No. 1 killer in most industrialized countries. A new study indicates that combining the use of a statin drug and niacin can reduce the risk of heart attack or hospitalization for chest pain by 70 percent among people likely...
Why Drugs Get Pulled off the Market
"But aren't drugs supposed to be safe?" According to Janet Woodcock, M.D., director of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), people tend to ask that question a lot when a drug is taken off the market....