ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Scientifically-designed fasting diet lowers risks for major diseases

More evidence for calorie restriction’s longevity effect

Supplementation with vitamin D associated with improved testosterone, erectile function among middle...

A Little Zinc Goes a Long Way

Vitamin D deficiency increases risk of chronic headache

Get the Most From Your Green Tea

VIDEO: The Best Brain Foods That Help Increase Your Memory!

Acupuncture boosts effectiveness of standard medical care for chronic pain, depression

Iron (And More) For Lasting, Natural Energy

Metabolic syndrome increases the need for vitamin E

 
Print Page
Email Article

New Drugs Called Riskier Than Old

  [ 6 votes ]   [ Discuss This Article ]
www.ProHealth.com • May 3, 2002




By Marc Kaufman

Washington Post Staff Writer

Wednesday, May 1, 2002; Page A01


Newly approved drugs are riskier than older ones and doctors should avoid prescribing them when equally effective and long-used medications are available, according to a study reported in today's Journal of the American Medical Association.

In a provocative review of a quarter-century of unexpected and harmful side effects from the most innovative new prescription drugs, the authors found that more than 10 percent had been taken off the market or required new warnings against dangerous "adverse reactions."

"Based on our results and those of others, clinicians should avoid using new drugs when older, similarly [effective drugs] are available," the authors conclude. "Patients who must use new drugs should be informed of the drug's limited experience and safety record."

The findings add to the increasingly contentious debate over whether the Food and Drug Administration is doing enough to protect consumers from the risks posed by new drugs.

Among the medications taken off the market recently were the nighttime heartburn drug Propulsid (removed because of fatal heart rhythm abnormalities), the diabetes drug Rezulin (removed after causing liver failure) and the irritable-bowel-syndrome treatment Lotronex (removed for causing fatal constipation and colitis). All three were taken off the market in 2000.

While the FDA's job is to ensure that drugs coming on the market are safe and effective, officials there acknowledge that a small number of harmful side effects undetected during pre-market trials are inevitably discovered only after a drug has been approved and used by millions of patients. Because the FDA approved many more drugs during the 1990s than in previous decades, more unexpected harmful side effects are appearing.

"Our data found that only half of all serious adverse reactions are detected seven years after a drug enters the market," said the study's lead author, Karen E. Lasser. "Millions of patients are exposed to potentially unsafe drugs each year."

In an accompanying commentary in the journal, a top official with the FDA's Center for Drug Evaluation and Research Policy, Robert J. Temple, argues that the study's assessment of the agency's track record on safety issues is misleading. He says many of the warnings added after the drugs entered the market reflected subsequent scientific findings or the discovery that medications known to be toxic turned out to be more toxic than expected.

"This is a useful study," Temple said in an interview. "But when I looked more carefully, many of the problems described are not good reasons to avoid using a new drug. . . . Patients needn't be nervous about using new drugs prescribed by their doctors."

Temple said recent changes in how drugs are developed should help limit the number of problematic side effects. He also said regulators are now focused, in particular, on potential liver damage from new drugs -- the cause of some of the most significant drug withdrawals.

The drug industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) yesterday called the JAMA study "misinformed and misleading."

"We note that Dr. Lasser et al. state that the benefit/risk ratio of new medicines sometimes shifts as new information is acquired after marketing, but they fail to state that it often shifts to the benefit side," PhRMA said in a statement. "For example, cholesterol-lowering drugs have been found after marketing to have significant additional benefits."

But Sidney Wolfe of Public Citizen's Health Research Group, a coauthor of the JAMA report, said that despite FDA assurances significant safety problems remain. "Rather than getting better, we believe the situation is just as bad, or worse," he said.

The authors of the study, most from Cambridge Hospital and Harvard Medical School, used FDA announcements and the Physicians' Desk Reference -- an annual compendium of drugs on the market -- to study how many medications were withdrawn and how many required new safety notices to doctors, called "black box" warnings. Between 1975 and 1999, they report, 548 new chemical entities were approved by the FDA as prescription drugs, and 56 were either withdrawn or given new black box warnings.

Because many of the 548 drugs were approved recently, the researchers used a probability analysis to estimate how many would require FDA action. Based on experience, they conclude that about 20 percent of the drugs would acquire a new black box warning over a 25-year period or would be taken off the market.

A decade ago, the FDA came under intense pressure from the drug industry and some legislators to speed its drug-approval process. Congress approved a program in 1992 that allowed the FDA to raise additional funds through a user fee program supported by the drug industry. Reauthorization of that program is being debated in Congress, where it has broad bipartisan support. However, some lawmakers and others argue that the user fees give the drug industry undue influence over the FDA, and have contributed to the kind of safety concerns raised in the JAMA article.

But the pressures to speed approvals continue, as illustrated by a poll conducted by the Competitive Enterprise Institute that was released yesterday. The institute, a free-market advocacy group, found in its poll that more than 60 percent of cancer specialists believe the FDA is still moving too slowly.


© 2002 The Washington Post Company



Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg Optimized Curcumin Longvida® Ultra EPA  - Fish Oil

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing
Running on Empty? Fuel Up with NADH Running on Empty? Fuel Up with NADH
Physically and Mentally Exhausted? How to Restore Energy at Its Source Physically and Mentally Exhausted? How to Restore Energy at Its Source
When a Negative is Positive - Goodnighties Recovery Sleepwear When a Negative is Positive - Goodnighties Recovery Sleepwear

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map