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new warnings for Procrit (Epogen) and Aransep:

The FDA in USA is strengthening warnings for both of these anemia drugs.

http://www.washingtonpost.com/wp-dyn...031100339.html

Increased potential for death is being reported with them.

They are also used in doping during the winter olympics increasingly.

FDA requests Warning For Sleep Drugs!

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html

Quote:

FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event................................

Zelnorm discontinued:

Here is an FDA report on the discontinuance of Zelnorm:

Quote:

FDA: Zelnorm Being Pulled From Market

ROCKVILLE, MD -- March 30, 2007 -- FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

FDA announces the following, effective immediately:

· At FDA's request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
· Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
· Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.
· Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation. In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and most patients -- 88% -- were women.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill. Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

FDA has also indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks. However, before FDA makes a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting.

SOURCE: FDA

This is how Zelnorm works... and its affects on serotonin seem to be what is
causing the cardiovascular incidents:

Quote:

Tegaserod is a 5-HT4 receptor partial agonist that binds with high affinity at human 5-HT4 receptors, whereas it has no appreciable affinity for 5-HT3 or dopamine receptors. It has moderate affinity for 5-HT1 receptors. Tegaserod, by acting as an agonist at neuronal 5-HT4 receptors, triggers the release of further neurotransmitters such as calcitonin gene-related peptide from sensory neurons. The activation of 5-HT4 receptors in the gastrointestinal tract stimulates the peristaltic reflex and intestinal secretion, as well as inhibits visceral sensitivity. In vivo studies showed that tegaserod enhanced basal motor activity and normalized impaired motility throughout the gastrointestinal tract. In addition, studies demonstrated that tegaserod moderated visceral sensitivity during colorectal distension in animals.

Zelnorm was used for irritable bowel syndrome, for selected patients with chronic constipation, and for those who use chronic opioid therapy for pain (which results in constipation).

Drug Identification:

This is a good reference for identifying drugs:

http://www.pharmer.org/identification

Mrs. D.:

Thank you for this information. I am one of those women whose whole life has been micromanaged by IBS.

I was literally loosing what life I had until Zelnorm.

And, it's not that I have a life now. However, w/Zelnorm I was/am on the road to living a normal life...

In your piece you said, "There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program."

How do I do this?

I am fearful that I may even loose my ability to earn a living without this product.

And, really, what life do I have if I can't work, go outside my home, develop & participate in life and relationships because of major symptoms of IBS?

My IBS is crippling. I am still on FMLA from its debilitating effects—

Thanks for any support, information or suggestions,

mmmstly

Patientsville.com

Here is a very interesting site. It details FDA medwatch reports.

http://www.patientsville.com/sitemap.htm

Keep in mind that some people's reactions may be due to other disease processes going on with them. Also the opposite factor should be considered, that many drug reactions go UNREPORTED.

So don't panic, but do be concerned and careful.

New warning for erectile dysfunction drugs:

http://ncpa.yellowbrix.com/pages/ncp...440559&ID=ncpa

Quote:

FDA Revises Cialis, Levitra, Viagra Labels
Source: United Press International
Publication date: 2007-10-22

The U.S. Food and Drug Administration has revised the labeling of the erectile dysfunction drugs Cialis, Levitra and Viagra to warn of possible hearing loss.

The FDA said the labels now will offer inform people of the potential risk of sudden hearing loss, and guide them on what to do if they experience sudden problems with their hearing.

In addition, the FDA said it plans to require the same changes in labeling for the drug Revatio, which is used to treat pulmonary arterial hypertension -- a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA said it asked manufacturers to revise product labeling after a very small number of patients reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

Patients taking Cialis, Levitra or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication, but should contact their health care provider for further evaluation.

More details here:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01730.html

Liver enzymes and drug interactions...

Each year more and more is learned about drugs interfering with each other, by either inducing metabolism or inhibiting it.

The subject of pomegranate juice just came up on Bipolar board, so I thought
I'd put up some charts that I found that people can consult. Doctors don't always know this information, or understand it.

http://www.healthanddna.com/drugchart.html

This link explains the effects of various juices at this time:
http://www.netwellness.org/question.cfm/44966.htm

and this link has just info about grapefruit:
http://www.fhma.com/grapefruit.htm

Lists are subject to change, as data changes. So keep that in mind.

Drug induced Nutrient Depletions....

I have started a thread on our Vitamin forum here for questions people may have on this subject.

Resources are posted there, so I won't repeat them here.

Some side effects from long term use of common medications affect our
body's ability to use certain nutrients. Vit D, calcium, zinc, magnesium, potassium B-complex are just some that are robbed from our bodies.

I have 2 textbook links and one web link posted here:
http://neurotalk.psychcentral.com/thread42135.html