Archive for the ‘FDA’ Category

Coumadin Sample WARNING!

WARNING!

If you are taking Coumadin, or know anyone taking Coumadin, it is imperative that you and they read this warning!

Bristol-Myers Squibb has made a grievous error in free sample packets of Coumadin they had manufactured.

If you have recently received a free sample pack of Coumadin from your doctor, DO NOT USE IT!

An alert has been just issued by the FDA for an urgent recall for the 1mg strength Coumadin sample packs because taking them could put you in dire straits.

The recall was initiated by Bristol-Myers Squibb when they realized that a key ingredient that activates the Coumadin was not working properly, which could make your medication extremely dangerous, if not deadly.

The unsafe sample packs are from lot numbers:

Lot# 9A48931A, 9A48931B, 9A48931C, all with expiration dates of January 2012.

Please pass this warning on to anyone you know is on heart medication.

To your good heath & longevity.

Ira Marxe
“The Good Health & Wellness Guy”

Copyrighted © 2010 – All Rights Reserved

Note: Good Health Supplements are dietary supplements and are not intended to diagnose, treat, cure or prevent any disease. Any statements have not been evaluated by the Food and Drug Administration. Readers should consult appropriate health professionals as necessary on any matter relating to their health and well-being. Individual results will vary and statements mentioned are anecdotal and may not represent typical results.

Malaria drug quinine (Qualaquin) for nocturnal leg cramps? Check again!

July 8, 2010 ­ Physicians should not prescribe the malaria drug quinine (Qualaquin) for nocturnal leg cramps ­ an off-label use ­ because it may result in serious and life-threatening hematologic adverse effects, the US Food and Drug Administration (FDA) announced today.

Quinine, marketed by AR Scientific, is approved only for uncomplicated malaria caused by the parasite Plasmodium falciparum, according to the agency.

The FDA issued a similar warning in 2006, but the agency noted today that the majority of quinine used in the United States is still for the prevention or treatment of leg cramps.

Quinine therapy may result in thrombocytopenia, which can cause serious bleeding, or hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura, which may lead to permanent kidney damage. The FDA said that it received 38 reports of serious adverse events associated with quinine between April 2005 and October 1, 2008, in the United States through its Adverse Event Reporting System. Only 1 patient was taking quinine to treat malaria. Two patients died.

Under a risk management plan approved by the agency, the drug’s manufacturer will issue a letter to prescribers warning of the risk for hematologic reactions to the drug. In addition, patients must be given a medication guide explaining what quinine is and is not approved for, and its potential adverse effects.

To report any adverse events related to quinine, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Osteoporosis Hip-Fracture Drug Risks?

Why am I not surprised that another highly popular 3.5 billion dollar drug (bisphosphonnate) turns out to be deleterious to your body.

Two new studies show the bones of some post-menopausal women who take a bone-loss drug like Actonel, Bonive, or Fosamax to ward off osteoporosis, result in hardening of their bones and eventual brittleness with a high risk of fracture of the spine or pelvis.

Researchers are now urging limiting the length of time people take these drugs.  The FDA is now reviewing the long term use of these drugs.

Here we are again spending a fortune on high priced prescription drugs which lead to the eventual  destruction of the very bones they were designed to protect, leaving these users at severe risk for spine and hip fractures.

Why are doctors prescribing these drugs in the first place when they have available a permanent cure for bone loss that is nutritional and only costs pennies a day?

Dr. Melvin Rosenwasser, chief of orthopedic-trauma surgery at Columbia University Medical Center in New York said, “These drugs are good drugs.  They strengthen bone and protect you from fractures for a while. (Italics mine)  But in some people they can become deleterious after a period of time.”

It is difficult for me to understand how a doctor, at his intellectual level, can claim that these expensive drugs are “good drugs” that will protect you from fractures “for a while”.

Whatever happened to Vitamin D-3, Calcium and Magnesium, which cost pennies a day, to naturally build bone strength and keep them strong for the rest of your life?

Read the rest of this entry »

FDA and Weight Loss Protection?

For a long time we have been telling you how the cozy relationship between the FDA and the drug companies negatively impacts on your health and how hard the FDA comes down on nutritional companies.

Here are two recent announcements by the FDA on weight-loss products —- one a drug and the other a nutritional supplement:

ANNOUNCEMENT ONE:

Giving giant drug companies a free pass. 

Last month, FDA officials announced a safety information review for orlistat, a weight-loss aid.

You probably know this drug by the brand name Alli, made by GlaxoSmithKline. It’s also sold at higher dosage as a prescription drug called Xenical, made by Roche.

At issue are 32 reports of “serious liver injury,” which include six cases of liver failure and 27 cases of hospitalization.

The FDA press release states: “FDA is not advising healthcare professionals to change their prescribing practices with orlistat.”

The agency also advises consumers to continue taking Alli and Xenical as directed.

ANNOUNCEMENT TWO:

A very different and very tough stance by the FDA if you are not a drug company but a supplement maker offering a similar end use product.

This past May, the FDA issued a consumer warning about several (but not all) Hydroxycut weight-loss products. All of these are non-drug items, available over-the-counter.

At issue are 23 reports of liver problems, ranging from jaundice and elevated liver enzymes (indicators of potential liver injury) to one death due to liver failure.

The FDA warning stated: “The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products”.

There it is, your FDA always looking out for your interest.

Heaven save us from their protection.

To your good heath & longevity.

Ira Marxe
“The Good Health & Wellness Guy”

Copyrighted © 2009 – All Rights Reserved

Health Reform?

Health Care Reform? – If it wasn’t so tragic, it would be a joke!

What is health care reform anyway?

It would appear to me that health care reform would mean ways to keep people from getting sick. Ways to keep people healthy.

That to me is real health care reform.

Instead we have the whole country battling over drugs and medical care while every year the number of people who develop a chronic disease grows larger and larger.

What is wrong with our Presidents — past, present, and probably future?

What is wrong with our senators and members of congress?  Do they all have their heads buried in the sand or is it all about greed and self-interest?

This is not a Democrat, Republican, or Independent issue— it’s about everyone!

We the people are being Read the rest of this entry »

Hazardous Food Additives

This is a special report from OCA (Organic Consumers Association).

Monosodium glutamate (MSG) is one of the most common and hazardous food additives on the market.

MSG is reportedly more toxic than alcohol, tobacco and many drugs.

MSG is an excitotoxin, so it tricks your brain into wanting to eat more and more foods containing the ingredient, even if you are already full.

Side effects of MSG include: obesity, eye damage, headaches, depression, fatigue and disorientation.

Food manufacturers know that health-conscious consumers try to avoid MSG, so it is oftentimes not listed in a product’s ingredients.

MSG is banned in organic foods.

According to USDA and FDA regulations, if MSG Read the rest of this entry »

Let me ask you a question…how much do you really know about the food you eat that you buy from your local supermarket and are serving to your family?

Are you hungry for change? If so, watch the provocative new film called “Food, Inc.”.

Here’s a short video trailer for you to watch.
NOTE: Video takes a few moments to load before it starts playing.

“In Food, Inc., filmmaker Robert Kenner lifts the veil on our nation’s food industry, exposing the highly mechanized underbelly that has been hidden from the American consumer with the consent of our government’s regulatory agencies, USDA and FDA.

Our nation’s food supply is now controlled by a handful of corporations that often put profit ahead of consumer health, the livelihood of the American farmer, the safety of workers and our own environment.

We have bigger-breasted chickens, the perfect pork chop, herbicide-resistant soybean seeds, even tomatoes that won’t go bad, but we also have new strains of E. coli—the harmful bacteria that causes illness for an estimated 73,000 Americans annually.

We are riddled with widespread obesity, particularly among children, and an epidemic level of diabetes among adults.”

To your good heath & longevity.

Ira Marxe
“The Good Health & Wellness Guy”

Copyrighted © 2009 – All Rights Reserved

It's Your Choice!

Most of the public never gets to hear about the many proven ways to heal ourselves  because our medical profession is an antiquated dinosaur bound to drugs.

Our FDA does not, and will not, recognize “so called” alternative ways.

In fact, the FDA has made it illegal to claim that a nutritional product or alternative way can heal you. If it is not a drug approved by the FDA, your cure claims will subject you to heavy fines and or jail.

Over the past decade it has been made very clear the strong influence Big Pharma has over our FDA.  Sometimes you would think they were running the FDA.

To make our health conserns even worse, our USDA, who should be insuring that we get safe, nutritional food to eat, is highly influenced by giant food processors allowing them, through over processing, to destroy much of the nutrients in the packaged food sold in our food markets.

Most all of these nutrient deficient foods also contain Read the rest of this entry »