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Media, News & Topics on prevention, diagnosis & treatment of cardiovascular disease
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Aspirin for Primary Prevention | Pentucket Medical Associates

Aspirin for Primary Prevention | Pentucket Medical Associates | Heart and Vascular Health | Scoop.it
Aspirin is used to prevent cardiac events like heart attack & stroke. Cardiologist Seth Bilazarian, MD explains aspirin use for primary & secondary prevention.
Seth Bilazarian, MD's insight:

The FDA no longer recommends aspirin for primary prevention

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Another caution about "natural" therapies: toxins in Red Yeast Rice extracts

Another caution about "natural" therapies: toxins in Red Yeast Rice extracts | Heart and Vascular Health | Scoop.it

Red yeast rice (RYR) is a commonly used dietary supplement for the management of dyslipidemia. In 2007, the Food and Drug Administration (FDA) issued a consumer warning to avoid RYR products because they may contain unauthorized drug (lovastatin) and also implemented Current Good Manufacturing Practices (CGMP) requiring that proper controls be in place by dietary supplement companies to ensure products are manufactured and processed in a consistent manner and produce high-quality products that are not adulterated with impurities or contaminants and are accurately labeled.

In this paper in Journal of Clinical Lipidology it is reported that the FDA had no information on the number of RYR manufacturers and their compliance with CGMP regulations. A total of 101 products containing RYR were reviewed. No product could be confirmed as passing any independent laboratory verification testing. Nearly one-half (42.6%) of the RYR product labels contained statin-related warnings (ie, potential for muscle pain or weakness, etc).

Currently, the FDA is not regulating manufacturers of RYR products and as a result, many of these products may contain monacolin K and toxins such as citrinin.

Seth Bilazarian, MD's insight:

Many patients have a false belief that "natural" therapies are safe, healthy and pure.  The FDA does not assess these products for potency, purity or safety.  Many of these products are produced outside the US.  People using these products should have a cautious skepticism about the benefits (unrpoven) but more importantly a significant hazard of impurities and toxins. Caveat Emptor.

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Nancy Rosas Delgadillo's curator insight, February 18, 2013 7:54 PM

Interesante artículo, sin embargo muy avanzado. 10 de 10

Ellen Diane's curator insight, February 20, 2013 8:09 AM

thank you for this

Rehabmyheart's comment, February 20, 2013 8:12 AM
I would come across many patients who were on statins plus the red yeast rice, talk about compounding effects!
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Facts About Generic Drugs Infographic

Facts About Generic Drugs Infographic | Heart and Vascular Health | Scoop.it

FDA infographic on generic drug safety and efficacy.

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JAMA Article Says FDA Let Risky Drugs Hit Market

JAMA Article Says FDA Let Risky Drugs Hit Market | Heart and Vascular Health | Scoop.it

My comment: Do you want your drug approvals too fast or too slow? As a practioner I would like access to new therapies for my patients so we can make best decisions based on our assessment of the risks & benefts from the avaialble data.  Making drugs available does not require them to be used.  Not approving drugs absolutely prevents us from using them.

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An FDA effort to speed approval of new medicines allowed drugs onto the market without proper safety analysis, according to two drug-safety experts.

" the FDA could strike a better balance of safety versus innovation by insisting that companies produce more safety and effectiveness data soon after the drug is approved—and by insisting on automatic withdrawal of a drug if the data don't materialize. "Once a drug is approved, it is often very difficult to put the genie back in the bottle,"

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FDA Approves Generic Versions of Plavix

FDA Approves Generic Versions of Plavix | Heart and Vascular Health | Scoop.it

My comment for patients:  this will move Plavix in the form of clopidogrel to the generic tier for patients with substantial savings on copayments.  For cash paying patients the cost should descend quickly from nearly 200/;month to less than 50 / month in the next 6 months because of the number of competitors.  To check the price at a pharmacy near you see my scoop it below.  Massachusetts Drug Card or go to link

https://reportal.restat.com/xpertrx/drugPrices

 

The price at my local pharmacy tfor 1 month on 5/19/2012 via this look up was $160.76 

 

Generic Plavix (Clopidogrel) approved by the FDA: Nine pharmaceutical companies will produce 2 different generic versions of the ubiquitous blood thinner. 

On the FDA website: Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs. http://goo.gl/3oAWQ  ;

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FDA Device Surveillance to Tap App

FDA Device Surveillance to Tap App | Heart and Vascular Health | Scoop.it
The FDA is creating a largely automated surveillance system to monitor safety of high-risk medical devices, and has authorized a cellphone app for doctors to simplify reporting deaths and injuries to the agency.
Seth Bilazarian, MD's insight:

"There's an app for that."  Physicians are often criticized for not doing a better job reporting adverse events and this is largely because the method for reporting to the FDA has been burdensome and difficult. An easy to use reporting strategy from a smartphone will increase my reporting dramatically.  The speed of reporting and analysis by FDA for actionable items should be significantly shortened.

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Seth Bilazarian, MD's comment, April 24, 2013 4:27 PM
#app, medical app, #chealth, #mHealth, FDA, adverse event reporting, Bilazarian
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Free Speech in Drug Claims?

Free Speech in Drug Claims? | Heart and Vascular Health | Scoop.it

My comment: The FDA prohibits drug or device manufactureres from promoting "off label" use.  The requirements to get a label indication is a high bar but is intended to protect the public from marketing that is not backed by good evidence.  Is off label promotion free speech or is it more like yelling fire in a crowded theater?

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The issue of free speech in prescription drug marketing will get a fresh look when a federal appeals court in San Francisco considers whether a biotech executive committed fraud in touting a lung-disease drug.

Potentially jeopardized in both cases is a set of FDA regulations prohibiting drug companies from off-label marketing, or marketing a medicine for purposes not approved by the agency. Also threatened is the government's extracting of billion-dollar settlements from companies that do just that.

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Pradaxa (dabigatran) Safety Review of Serious Bleeding Events by FDA

UPDATED 11/02/2012. Results of FDAs Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.
My comment -= I hope this review by the FDA reassures patients that the use of Pradaxa is safe as an alternative to warfarin,. This adds to the randomized trial RE-L. Patients are being unnecessarily frightened by TV ads by malpractice attorneys and decisions about options fro treatment are being complicated without reason.,
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FDA Approvals Are a Matter of Life and Death

FDA Approvals Are a Matter of Life and Death | Heart and Vascular Health | Scoop.it

Take Home Message:  FDA's charge to evaluate device safety can be accomplished without the slowness of the approval process. I have patient's frankly dying as they wait for this device which has taken 5 years longer to approve here than in Europe, Canada & Australia. Pendulum needs to swing back.

 

In November, FDA approved the Sapien Transcatheter Heart Valve, for treatment of severe aortic valve stenosis. The Sapien valve can be implanted from the groin artery without surgery. It's a boon for patients who are too sick to endure open-heart surgery. Clinical trials found that almost 70% of patients receiving Sapien valves were alive one year after treatment, while only 50% of those without replacement survived that long.

This would be a great story for Americans, but for one frustrating detail: The Sapien valve has been available in Europe since 2007, saving lives there but not here. Today, Americans wait as much as 60% longer than they did in 2005 for new lifesaving and life-enhancing medical devices—such as stents & defibrillators—to reach the market, according to a GAO report.

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