Cooking with Char Archives: living/cooking/char/index.html  

---------------------------------

U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001

A Look at FDA Approvals in 2000
From drugs that bring relief to devices that detect disease, many products approved in the year 2000 represent important advances in the prevention, diagnosis, and treatment of serious conditions. Last year, the Food and Drug Administration approved 160 new drugs, biological products, and medical devices.

Three of FDA's centers--the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH)--give premarket approval for new health-care products. They also prevent unsafe or ineffective products from going on the market, assure adequate labeling for approved products, and monitor the effects of marketed therapeutics. 

FDA's Center for Drug Evaluation and Research (CDER) issued 98 approvals for original new drug applications in the total median time of 11.2 months. The Center for Biologics Evaluation and Research (CBER) issued 13 approvals for product license or biological license applications in the median time of 25.1 months. The Center for Devices and Radiological Health (CDRH) approved 49 product marketing applications for original devices in the median time of 9.6 months. CDRH approved four additional products under FDA's Humanitarian Use Exemptions program (for devices with a patient population up to 4,000) in a median time of 3.5 months.

Along with approving 98 original new drugs, CDER issued 244 approvals for generic versions of drugs on which the patents had expired. FDA approved 20 products classified as priority drugs in a median time of six months. And FDA approved 27 new molecular entities (products with ingredients never before marketed in the United States) in the median time of 15.6 months. Along with approving a host of important new medical products in 2000, FDA has continued to exceed virtually all of its performance goals under the Prescription Drug User Fee Act.

In addition to approving 53 original new medical devices, CDRH cleared for the market 3,457 so-called 510(k) devices. These are products similar to devices already in use. CBER issued 13 approvals for product license or biological license applications.

Among the important products that passed FDA's rigorous review for safety and effectiveness are Zyvox (linezolid), the first of a new class of antibacterial drugs that addresses the emerging public health threat of vancomycin-resistant bacterial infections. Vancomycin has been the treatment of last resort for an organism called Enterococcus faecium for many years. 

And the approval of Visudyne (verteporfin for injection) brought the first therapy to slow vision loss in people with wet age-related macular degeneration, a condition that annually causes blindness in one million Americans over age 55. 
Among the significant medical devices approved by FDA was the Da Vinci Surgical System, which uses cutting-edge robotics technology to perform laparoscopic gall bladder and reflux disease surgery. The Cordis Checkmate System and Novoste Beta Cath System are approved devices that use catheters to deliver radiation inside a coronary stent after a blocked artery is reopened. The radiation helps reduce the risk of repeated narrowing of the artery. 

In addition to elderly patients and those with heart disease, children, women, and patients with cancer are among the groups that particularly benefit from FDA approvals in 2000. Here are some examples:

Pediatric Products
FDA approved an unusually high number of health-care products for children. In recent years, Congress and FDA have stimulated increased pediatric submissions by offering limited pediatric exclusivity to manufacturers who conduct studies for pediatric use of their products. Several new products were either designed for the youngest patients or were adult drugs with pediatric indications. 

The OxiFirst Fetal Oxygen Saturation Monitoring System represents the first major technological development in fetal monitoring in three decades. The system measures oxygen saturation in a baby's blood as a sign of fetal health during labor and delivery. FDA also approved Prevnar, a vaccine to prevent invasive pneumococcal diseases that can cause brain damage and death. The vaccine is the first of its kind for infants and toddlers under age 2. 

Children with asthma can benefit from last year's approval of Pulmicort Respules (budesonide inhalation suspension), the first anti-inflammatory corticosteroid for inhalation using a nebulizer in this age group. This is an important feature because toddlers frequently cannot use metered-dose inhalers. FDA approved Relenza (zanamivir) to treat uncomplicated influenza A and B in patients age 7 and up. And Tamiflu (oseltamivir phosphate) oral suspension received approval for the prevention of the influenza virus in patients 13 and older. Influenza causes 20,000 deaths and 100,000 hospitalizations a year.

Examples of drugs approved last year that had both adult and pediatric indications are Kaletra, a combination of lopinavir and ritonavir, which received accelerated approval for HIV treatment; Unithroid (levothyroxine sodium), a thyroid replacement drug; and Protopic (tacrolimus), an ointment that treats moderate to severe eczema. FDA also added pediatric use to the labeling of 13 adult medications, including ibuprofens Motrin and Advil, and Zantac (ranitidine) for stomach acid reflux. And the agency approved lowering the age for the Nucleus 24 Cochlear Implant from 18 months to 12 months for infants who are profoundly hearing-impaired. 

Options for Women
Three-quarters of the more than 8 million Americans with rheumatoid arthritis are women. FDA approved Remicade (infliximab) to treat rheumatoid arthritis in patients with inadequate response to methotrexate. Another approval that primarily benefits women is Novantrone (mitoxantrone hydrochloride), a cancer drug, to treat advanced or chronic multiple sclerosis. This disease affects up to 350,000 Americans, most of whom are women. 

FDA also approved Mifeprex (mifepristone) for the termination of pregnancy within 49 days from the beginning of the last menstrual period. And following clinical studies involving 9,000 women, the agency also allowed continued marketing of two types of saline-filled breast implants that are approved for breast augmentation and breast reconstruction in women 18 years or older. 

Progress for Patients With Cancer
FDA approved three medical devices last year to help fight cancer, the second deadliest disease in the United States, affecting eight million Americans. The Optical Biopsy System is a laser system that helps doctors distinguish small, harmless growths from precancerous growths in the colon. 

The Senographe 2000D is a mammography system that produces digital images. Unlike radiographic film, digital images can be electronically stored and transferred so specialists can evaluate them at a remote location. The images can also be manipulated to correct for under- or over-exposure. Early diagnosis remains the best weapon against breast cancer, which annually affects 185,000 women, 46,000 of whom die of the disease. 

The third device in this category is the FocalSeal-L Surgical Sealant, approved for sealing air leaks in lungs following the removal of cancerous tumors. Light activates the sealant, which is "painted" on the lung. FDA reviewed the sealant on an expedited basis because of its potential importance for patients with lung cancer. 

As for cancer medications, two-Trisenox and Mylotarg-were approved for cancers of the white blood cells. Trisenox (arsenic trioxide) was found safe and effective to treat acute promyelocytic leukemia (APL) in patients who have not responded to, or have relapsed following all trans-retinoic acid and anthracycline-based chemotherapy. Trisenox, a priority drug, was approved in six months. The product's total development time was only three years.

Other FDA approvals designed to benefit patients with cancer included Mylotarg (gemtuzumab ozogamicin) for the treatment of CD33 positive acute myeloid leukemia for patients 60 years or older who have relapsed for the first time and are not suitable candidates for the standard cytotoxic therapy. FDA also approved Novaldex (tamoxifen citrate) to reduce risk of invasive breast cancer for women with preinvasive cancer of the ducts.

---------------------------------
Notes and Insights:

Happy Birthday!
Happy Birthday Dee Tee aka Diana Taggart, Cindy aka Pinkyscrossed, Donna aka Nubby and Lyn!! Check out all the birthdays at community/birthday/  and make sure to send them an arthritis-friendly e-card: cgi-bin/postcards/postcard.pl  

Wanna help?
Having surgery? Starting a new drug or treatment? Filing for disability? Keep an Arthritis Insight journal so all of our members can share and learn from your experience. If you want to keep a journal just let us know. 
Write an article! We always need articles on all subjects relating to arthritis. 
C'mon folks, we can't do this without you.

Donate!
Arthritis Insight is now a not for profit organization! We were never here to make a profit, but now it is official. That won't change anything, we are still working with the same mission: to use the internet to provide timely, accurate information and emotional support to the hundreds of millions of people with arthritis and their families around the world. We hope to continue to do so until there is a cure for all of the 170+ types of arthritis and our services are no longer needed. (What a wonderful day that will be!)
Arthritis Insight will always be free for anyone to use, we will never charge any fees. We try very hard to keep our operating costs as low as possible, but running a website as large as Arthritis Insight can be expensive. To date we've relied on our few sponsors for support and have paid for many of the expenses out of our own pockets. No one on our staff currently receives a paycheck for their hard work and dedication. Although you are not obligated in any way, if you are financially able to help support Arthritis Insight, it would be greatly appreciated. In exchange for your donation you'll receive some thank you gifts, a tax deduction and the satisfaction of knowing you are partly responsible for the entire Arthritis Insight Community.
See about/donate.html for more information.

Thank you!!!
A great big thank you to our "Diamond Level" Corporate Benefactor, allaboutarthritis.com. Please stop by their site and say hello! http://allaboutarthritis.com 
And another thank you to Donna Vernon for her generous donation.

Weekly News Summary
Karen Sears

SUPPLEMENT DOES NOT SLOW BONE LOSS, STUDY SHOWS
An over-the-counter supplement marketed as a natural way to prevent bone thinning appears ineffective, according to results of a 3-year study in Denmark. In fact, researchers found, some women who took the supplement experienced a drop in their white blood cell counts, a condition that can impair the immune system.
Reuters Health, Mar 20
http://dailynews.yahoo.com/h/nm/20010320/hl/bones_1.html 

TAI CHI MAY EASE ARTHRITIS PAIN IN ELDERLY
Elderly people with painful arthritis may find relief in an ancient Chinese exercise that combines slow movement with meditation, preliminary study findings suggest.
Reuters Health, Mar 19
http://dailynews.yahoo.com/h/nm/20010319/hl/arthritis_taichil_1.html 

EXERCISE THROUGHOUT OLD AGE MAY FIGHT THE "BLUES"
Although regular exercise is believed to boost older people's moods, it may not have long-term antidepression power. New research suggests that once the elderly stop being active, the psychological benefits wane.
Reuters Health, Mar 19
http://dailynews.yahoo.com/h/nm/20010319/hl/aging_exercise_1.html 

UVEITIS-RELATED INFLAMMATORY DISEASES IDENTIFIED
Inflammatory rheumatic diseases and other comparable conditions often appear to be important causes of severe uveitis, which leads to visual handicap and blindness.
Reuters Health, Mar 19 (free registration required)
http://rheumatology.medscape.com/reuters/
prof/2001/03/03.20/20010319epid002.html 

PAGER HELPS PATIENTS WITH MEMEORY PROBLEMS
A paging system may help people whose memory has been impaired by injury or stroke to remain independent, a new study reports.
Reuters Health, Mar 16
http://dailynews.yahoo.com/h/nm/20010316/hl/pager_1.html 

THROMBIN INHIBITION TREATS RHEUMATOID ARTHRITIS IN MICE
In mice, thrombin inhibition with hirudin can prevent the onset of collagen-induced arthritis, a model of rheumatoid arthritis, and ameliorate established arthritis, according to a report in the March issue of the Journal of Clinical Investigation.
Reuters Health, Mar 16 (free registration required)
http://rheumatology.medscape.com/reuters/
prof/2001/03/03.19/20010316scie001.html 

TOP NUMBER IS MOST IMPORTANT IN BLOOD PRESSURE
Doctors have traditionally focused on the lower, or diastolic, number in blood pressure readings when treating their patients with high blood pressure. However, studies over the past few years have suggested that it is the higher, or systolic, number that actually puts people at greater risk for death and disability from heart disease and stroke. Now a new study helps to explain which high blood pressure patients may be most affected by this form of hypertension.
Ivanhoe Newswire, Mar 16
http://www.ivanhoe.com/docs/newsflash/
topnumberismostimportantinbloodpressure.html 

NUMBER OF REPORTED LYME DISEASE CASES ON THE RISE
You may be more likely to contract Lyme disease now than you were in 1990, but probably only if you go hiking in Connecticut in July wearing a short-sleeved shirt and shorts, study findings suggest.
Reuters Health, Mar 15
http://dailynews.yahoo.com/h/nm/20010315/hl/lyme_1.html 

INJURY DANGER PROMPTS LAWNMOWER RECALL
About 40,000 Ariens, Scotts and Husqvarna brand lawnmowers are being recalled due to fears the propeller can detach and injure users.
Reuters Health, Mar 15
http://dailynews.yahoo.com/h/nm/20010315/hl/lawnmower_1.html 

PROTECTIVE EFFECT OF APPENDECTOMY UNCOVERED
Noting that people who have had their appendixes removed have a low incidence of ulcerative colitis, the often-painful inflammation of the colon and rectum, doctors have long speculated that an appendectomy may somehow
protect against the disease. A new study, however, shows that this protection is really only afforded those who suffered a bout of appendicitis prior to their appendectomy and who were under age 20 when they had the operation.
Ivanhoe Newswire, Mar 15
http://www.ivanhoe.com/docs/newsflash/
protectiveeffectofappendectomyuncovered.html 

MEDITATION MAY HELP FIBROMYALGIA PATIENTS
Meditation may be helpful in reducing the pain, fatigue and sleep deprivation experienced by patients who suffer from the poorly understood chronic condition known as fibromyalgia, according to researchers.
Reuters Health, Mar 14
http://dailynews.yahoo.com/h/nm/20010314/hl/meditation_1.html 

HEALTH INDUSTRY WANTS PRIVACY RULES DELAYED
Key members of the health care industry want the Bush administration to delay medical records confidentiality rules--already pushed back from February to April--for several more months, officials said Wednesday.
Reuters Health, Mar 14
http://dailynews.yahoo.com/h/nm/20010314/hl/privacy_3.html 

LIVER PROBLEMS LINKED TO ARTHRITIS DRUG
Severe liver reactions--some with fatal outcomes--have occurred in patients treated with Aventis' novel rheumatoid arthritis drug Arava (leflunomide), according to the European Medicines Evaluation Agency (EMEA).
Reuters Health, Mar 14
http://dailynews.yahoo.com/h/nm/20010314/hl/liver_2.html 

APPROACH OFFERS HOPE FOR OSTEONECROSIS
A new treatment for osteonecrosis of the hip is currently being studied and could offer relief -- and hope -- to patients suffering from the painful condition.
Ivanhoe Newswire, Mar 14
http://www.ivanhoe.com/docs/newsflash/
approachoffershopeforosteonecrosis.html 

ALLEGRA ABSORPTION BLOCKED BY FRUIT JUICE
People who are taking the antihistamine Allegra (fexofenadine) may want to take the drug with water instead of fruit juice, researchers suggested at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics.
Reuters Health, Mar 13
http://dailynews.yahoo.com/h/nm/20010313/hl/allegra_1.html 

HIGHER-DOSE ALENDRONATE [FOSOMAX] GIVEN WEEKLY HAS SAME EFFECT AS DAILY
DOSING
Alendronate administered weekly in single 35- or 70-mg doses produces approximately the same therapeutic effect as the 5- and 10-mg tablets administered daily, investigators reported at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics.
Reuters Health, Mar 13 (free registration required)
http://rheumatology.medscape.com/
reuters/prof/2001/03/03.14/20010313clin019.html 

INCREASED RISK OF LUPUS NEPHRITIS LINKED TO GENETIC FACTOR IN CAUCASIANS
Among Caucasians with systemic lupus erythematosus (SLE), a specific genetic factor increases the risk of nephritis, according to a report published today in the March 13th issue of Arthritis and Rheumatism.
Reuters Health, Mar 13 (free registration required)
http://rheumatology.medscape.com/
reuters/prof/2001/03/03.14/20010313clin007.html 

HRT MAY PREVENT KNEE OSTEOARTHRITIS IN POSTMENOPAUSAL WOMEN
Postmenopausal women who receive long-term estrogen replacement therapy appear to have more knee cartilage than women not receiving estrogen, which may protect them against osteoarthritis of the knee, according to Australian researchers.
Reuters Health, Mar 13 (free registration required)
http://rheumatology.medscape.com/
reuters/prof/2001/03/03.14/20010313clin016.html 

---------------------------------
Contribute
Have you written something you think our subscribers would like to read? Send it to Tina@arthritisinsight.com and maybe we'll use it in our newsletter.

---------------------------------
A Closing Thought

Gratitude

Sometimes in life, things happen too fast. 
We barely solve one problem,
when two new problems surface. 
We're feeling great in the morning, 
but we're submerged in misery by nightfall.
Every day: we face interruptions, 
delays, changes, challenges, 
personality conflicts and disappointments. 
Often when we're feeling overwhelmed, 
we can't see the lessons in these experiences.
That's called a "Scotoma"
(an inability to see what is blatantly in front of us).
One simple concept can get us through 
the most stressful of times.

It's called gratitude. 
Learn to say, thank you, 
for these problems and feelings: 
thank you for the way things are, 
I don't like this experience, 
but thank you anyway.
Force gratitude until it becomes habitual. 
Gratitude helps us stop 
trying to control outcomes. 
It is the key that unlocks 
positive energy in our life. 
It is the alchemy that turns 
problems into blessings, 
and the unexpected into gifts.
Today, I will be grateful. 
I will start the process of turning 
today's pain into tomorrow's joy.
REMEMBER:
TO SMILE AND SMILE AND SMILE
AND SMILE!!
Pretty soon, it will take hold.
Besides, 
it is the only thing you cannot give away.
When you give someone a smile,
you always get one back. 

Unknown~

---------------------------------

If you wish to advertise in the Arthritis Insight Newsletter, contact us at
advertising@arthritisinsight.com.

If you wish to unsubscribe to this newsletter, just let us know.

Arthritis Insight Newsletter Copyright 2001

Staff
Page last updated on February 28, 2001