Navigation Links
FDA Advisers Reject Over-the-Counter Statin
Date:12/13/2007

sterol treatment gap," Merck said in a prepared statement. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

Some experts agree with the idea of over-the-counter statins.

"There is a public health benefit in making statins available over the counter," said Dr. Antonio M. Gotto Jr., a dean and professor of medicine at Weill Cornell Medical College in New York City, a former president of the American Heart Association, and a consultant for Merck.

Statins are safe and effective, Gotto said. "In addition, the American population has reached the point where they are able to assume a greater degree of responsibility for their own health care," he said.

However, a preliminary FDA report released Tuesday concluded that the Merck proposal should be rejected, in part over worries that consumers would not be able to safely judge whether they were good candidates for the drug.

According to that report, Mevacor could be "a reasonably safe and effective" option -- if consumers used it properly. But studies done by Merck failed to show that most people could judge if they needed the drug or not. In addition, some 30 percent of those who said they would buy the drug over the counter have heart disease or diabetes or had had a stroke -- conditions that need a doctor's care, the report said.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Dr. Sidney Wolfe
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. FDA Advisers Urge Ban on Cold Medicines for Young Children
2. U.S. Advisers OK Nasal Spray Flu Vaccine for Young Children
3. Study provides hope that some transplant patients could live free of antirejection drugs
4. Study provides hope that some transplant patients could live free of anti-rejection drugs
5. DNC: South Carolina Rejecting Romneys Smooth Talk on Health Care
6. Billions Directed to Baghdad ... Millions Rejected for Children
7. Billions Directed to Baghdad ... Billions Rejected for Children
8. AARP Calls on State Regulators to Reject Proposed Settlement of TXU Buyout
9. The politics of the playground: lack of athletic skill often means loneliness and peer rejection
10. Breakthrough in organ rejection diagnosis examines gene behavior
11. Alcohol may amplify chronic rejection in lung transplants
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Reject Over-the-Counter Statin
(Date:5/26/2015)... 26, 2015 Surging to over 674,923 ... the leading online health and wellness sites, Consumer Health ... online community. It has proven to be a ... articles, watch videos, ask questions and interact with the ... the official Consumer Health Digest YouTube Channel has offered ...
(Date:5/26/2015)... Abington is pleased to announce ... practice with seven medical professionals, has joined Abington ... site in the United States to be recognized ... the National Committee for Quality Assurance. , Family ... sick care – including routine gynecology care and ...
(Date:5/26/2015)... (PRWEB) May 26, 2015 3,000 senior ... to explore and debate the future of the connected ... Freer Logic’s steering wheel that can read a driver’s ... to control a driving simulator by mind alone just ... of Freer Logic said: “We are working on cognitive ...
(Date:5/26/2015)... CO (PRWEB) May 26, 2015 It ... diverse community foundation in Colorado. On Wednesday, May 13, ... ushered in a new era of community-based giving with ... Titled “Our Future in the Making,” the event celebrated ... The Denver Foundation to mobilize resources for good. , ...
(Date:5/26/2015)... 26, 2015 On May 26, 2015, My ... salesman and distributor Dwayne Windfall. At the start of the ... that has some unique characteristics with it, so could you ... Windfall replies saying, “I was reading the newspaper looking for ... they were looking for a person with hustle. I responded ...
Breaking Medicine News(10 mins):Health News:Consumer Health Digest Official YouTube Channel: A Reliable Source of Health Information 2Health News:Family Medicine, Geriatrics and Wellness Joins Abington Health Physicians 2Health News:The World’s Biggest Connected Car Exhibition is Back in Detroit 2Health News:The World’s Biggest Connected Car Exhibition is Back in Detroit 3Health News:Celebrating "Our Future in the Making" 2Health News:Celebrating "Our Future in the Making" 3Health News:My Positive Perspective Broadcasts Episode with Oceans 6 to Discuss Their Role in Helping the Community 2
... TUESDAY, May 22 (HealthDay News) -- Healthier lifestyles and better ... for Americans with diabetes between 1997 and 2006, especially ... government report shows. During that time, deaths from all ... deaths caused by heart disease and stroke in this group ...
... YORK (May 22, 2012) -- Up to half of all prostate ... "fusion" gene and formation of its unique protein -- but no ... Cornell Medical College researchers have found that in these cancer cells, ... known as a chromatin, is warped in such a way that ...
... MTV programs about teenage pregnancy -- "16 and Pregnant" and ... the shows glamorized teenage pregnancy, while supporters said they discouraged ... suggests they,re both right. The study, which will appear ... female students because of the high dropout rate associated with ...
... It,s quite common for a female song sparrow to stray ... door, but a new study shows that sleeping around can ... The American Naturalist, found that offspring conceived outside ... than within-pair offspring. The findings throw a monkey wrench into ...
... (HealthDay News) -- Colonoscopies helped doctors detect a high ... the screening for the first time, a new study ... made available to otherwise healthy elderly people who have ... Grand Rapids Medical Education Partners, and colleagues from Spectrum ...
... of Environmental Health Sciences (NIEHS), part of the National ... Research Program (SRP) at the University of California, San ... grant will fund continued research on the molecular and ... and other hazardous waste sites. It is the ...
Cached Medicine News:Health News:U.S. Sees Drop in Deaths Linked to Diabetes 2Health News:U.S. Sees Drop in Deaths Linked to Diabetes 3Health News:Scientists unravel role of fusion gene in prostate cancer 2Health News:Scientists unravel role of fusion gene in prostate cancer 3Health News:Scientists unravel role of fusion gene in prostate cancer 4Health News:Viewers' family background affects how they react to MTV shows 16 and Pregnant, Teen Mom 2Health News:Viewers' family background affects how they react to MTV shows 16 and Pregnant, Teen Mom 3Health News:For monogamous sparrows, it doesn't pay to stray (but they do it anyway) 2Health News:Colonoscopy May Detect Curable Cancer in Elderly: Study 2Health News:UC San Diego Superfund Research Program receives $15 million grant renewal 2
(Date:5/26/2015)... , May 26, 2015 ... has announced the addition of the ... by Type (Integrated Computerized Physician Order Entry, ... (Hardware, Software, Services) - Forecast to 2019 ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ...
(Date:5/26/2015)...  PAREXEL International Corporation (NASDAQ: PRXL ) announced ... Sachs Healthcare Conference in Palos Verdes, CA.  Josef ... be making a presentation on PAREXEL and discussing business ... 2015. A live webcast of the presentation ... website at www.PAREXEL.com in the Upcoming Events ...
(Date:5/26/2015)...  EndoChoice today announced the launch of its initial ... which will represent 25.6% of its outstanding common stock ... corporation in connection with the offering. The initial ... $15 and $17 per share. The underwriters for the ... up to an additional 937,500 shares of EndoChoice common ...
Breaking Medicine Technology:North American Computerized Physician Order Entry Market 2015-2019 2PAREXEL International To Present At Goldman Sachs Healthcare Conference 2EndoChoice Announces Launch of Its Initial Public Offering 2
... 15, 2011 Pharmaceutical companies are dramatically increasing ... meet the demands of a patient-empowered, data-driven, outcomes-focused ... alone, pharmaceutical company investment in smart phone apps, ... other programs increased 78%, as companies embrace a ...
... Unilife Corporation ("Unilife" or "Company") (Nasdaq: ... the three and six months ended December 31, 2010 (Fiscal ... Completed, on-schedule, the construction of a new ... staff now working out of the new facility ...
Cached Medicine Technology:Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 2Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 3Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 4Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 5Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 2Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 3Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 4Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 5Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 6Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 7
10 L, Bulk Recommended for 2, 5 and 10 L pipettes....
10 L, Bulk Recommended for 2, 5, 10 L pipettes....
... Theken eDISC is a revolutionary advancement in ... assess and manage their patients. The eDISC's ... the eDISC from 1st and 2nd generation ... loads of the lumbar spine, the eDISC ...
... Resistant Tips offer a safe alternative to ... designed for applications such as PCR(a), pipetting ... ART Tips are excellent for tissue culture, ... ART Tips prevent aerosol contaminants and liquids ...
Medicine Products: