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The U.S. Food & Drug Administration in association with The Center for Drug Evaluation and Research has released a podcast regarding the recent Permax Recall.

The information contained in the podcast is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA / CDER

Run Time — 6:32 minutes

>>> CLICK HERE TO LISTEN TO PERMAX RECALL PODCAST <<<

Full Transcript Below

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On March 29, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Permax.

The drug is also known and marketed by its generic name pergolide [per-go-lide].

I am Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

We are notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage.

Two new studies showed that patients with Parkinson’s disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug.

Pergolide is a member of a class of drugs known as dopamine [dough-pah-mean] agonists and is used with levodopa and carbidopa to manage the signs and symptoms of Parkinson’s disease, which include tremors and slowness of movement.

If you are a patient with Parkinson’s disease who is taking pergolide, you should take these two steps:

• First, contact your health-care professional to discuss alternate treatment options.
• Second, DO NOT STOP taking Pergolide without consulting your health-care professional. Stopping pergolide too quickly can be dangerous and several other effective treatments are available.

If you are a health-care professional who prescribes pergolide, you should consider the three following items:

• First, Assess your patient’s need for dopamine-agonist therapy. If continued treatment with a dopamine-agonist is necessary, another dopamine-agonist should be substituted for pergolide. There are other dopamine agonists approved for the treatment of Parkinson’s disease that are not associated with heart valve damage. Published transition regimens describe the conversion from one dopamine-agonist to another.
• Second, if treatment with a dopamine-agonist is to be discontinued, pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine-agonist therapies can be dangerous. Instead, gradually decrease the dose of pergolide.
• Third, you should tell patients who will be taken off pergolide that other effective options for treatment exist, including three other dopamine agonists that are not associated with damage to heart valves.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem.

Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

In light of this additional safety information and the availability of alternative treatments for Parkinson’s disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution.

The companies will, in cooperation with us, work to remove from the market both Permax and generic versions of pergolide.

The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health-care professionals and patients to discuss appropriate treatment options and to change treatments.

One of the drugs that was included in the recent studies showing increased chance of heart valve problems is another dopamine agonist — Dostinex — also known by the generic name Cabergoline.

This drug is approved in the united states for the treatment of hyperprolactinemic [hyper-pro-lack-teh-knee-mick] disorders — conditions in which there are elevated levels of prolactin [pro-lack-tin] in the blood.

Dostinex is not approved in the United States for the treatment of Parkinson’s disease. For hyperprolactinemic disorders, a considerably lower dose of Dostinex is used. At these lower doses of Dostinex, there appears to be little chance of heart problems; therefore, Dostinex will remain on the U.S. market for the treatment of hyperprolactinemic disorders.

We are working with the manufacturers of pergolide to determine if it is possible to make the drug available to those few patients who are currently taking pergolide under these two conditions:

• First, where previous efforts to switch to a different treatment have been unsuccessful.
• Or, second, where efforts subsequent to this advisory to switch therapies are also unsuccessful.

In the interim, health-care professionals and patients should consider all treatment options with the understanding that in the future, the drug may no longer be available.

We are asking health-care professionals to report serious adverse events in connection with pergolide to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

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Do I Have a Permax or Pergolide Lawsuit?

If you or a loved one have taken Permax or Pergolide and suffered from any of the side effects listed below, you should contact us immediately. You may be entitled to compensation and we can help.

Side Effects

• heart-valve damage (Aortic and Mitral Valve Injuries)
• Primary Pulmonary Hypertension
• cardiac valvulopathy
• valvular heart disease
• leaky heart valves
• pulmonary fibrosis (retroperitoneal, pleural, and pericardial fibrosis)

Click Here To Learn More: Permax (Pergolide) Recall Information

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The U.S. Food & Drug Administration in association with The Center for Drug Evaluation and Research has released a podcast regarding the recent Zelnorm Recall.

The information contained in the podcast is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA / CDER

Run Time — 4:57 minutes

>>> CLICK HERE TO LISTEN TO ZELNORM RECALL PODCAST <<<

Full Transcript Below

[music]

On March 30, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Zelnorm.

The drug is also known and marketed by its generic name Tegaserod [te-gas-a-rod] maleate.

I’m Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

FDA issues this public health advisory to inform patients and health-care professionals that the sponsor of Zelnorm, 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.

We announce the following four items effective immediately:

• First, at our request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Second, patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• Third, 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.
• Finally, 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 the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years-of-age with chronic constipation.

In late February and early March 2007, Novartis Pharmaceuticals gave us 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 percent 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 or zero point one percent, 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 zero point zero one percent 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.

We have 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 we make a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting.

We are asking health care professionals to report serious adverse events in connection with Zelnorm to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

[music]

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit