Navigation Links
FDA Panel Considering Over-the-Counter Statin
Date:12/13/2007

Experts oppose idea on medical and safety grounds

THURSDAY, Dec. 13 (HealthDay News) -- For the third time in seven years, a U.S. Food and Drug Administration advisory panel has been asked to recommend making Merck & Co.'s statin drug Mevacor available over the counter.

But with groups such as the American Medical Association, Public Citizen and Consumers Union lined up against it, experts think Merck's proposal is likely to be rejected once again when the panel decides after its meeting Thursday.

"The third time is not the charm," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "It's time to move on."

Merck's proposal is being presented to a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. The FDA does not have to follow the advice of its advisory panels, but it usually does.

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck stated. "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."

However, in 2000 and in 2005, the FDA rejected similar proposals because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor the people taking stat
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4 5

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Considering Over-the-Counter Statin
(Date:10/22/2014)... 2014 For Dr. Iris Hunter, a job ... an extension of her life’s mission. Her extensive experience in ... owner of FirstLight HomeCare, make it clear that Hunter’s mission ... that my work makes a difference in the lives of ... so after much research, I felt ready to start on ...
(Date:10/22/2014)... Shriners Hospitals for Children® and UK HealthCare ... location of Shriners Hospitals for Children - Lexington from ... University of Kentucky Albert B. Chandler Hospital. The new ... and operated by Shriners Hospitals for Children, and designed ... their families well into the future. , “The quality ...
(Date:10/22/2014)... 22, 2014 With the Affordable Care Act ... by the American Institutes for Research (AIR) finds that three ... use health insurance, but 42 percent say they are not ... before signing up for coverage. , The AIR survey found ... percent able to calculate correctly how much they owe for ...
(Date:10/22/2014)... Plano, Texas (PRWEB) October 22, 2014 ... convenience of completing their continuing education at home ... now have access to 20 brand new, premium ... HomeCEUConnection.com’s robust catalog of over 2,000 hours ... to fully customize their educational experience. With such ...
(Date:10/22/2014)... CA (PRWEB) October 22, 2014 Lintelus, ... Cormier, Sr. Vice President of Sales, will be speaking ... upcoming Meetings Technology Expo on October 28, at the ... be hosting a booth as well as a Tech ... Lintelus Meeting can create a more engaging event experience. ...
Breaking Medicine News(10 mins):Health News:Dr. Iris Hunter to Host Grand Opening of FirstLight HomeCare Tomorrow 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 2Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 4Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2
... at greater risk of heart-rhythm abnormality: study , TUESDAY, ... severe sleep-related breathing problems are at increased risk for ... study included 2,911 men who underwent sleep testing between ... paused or shallow breathing during sleep were more likely ...
... Inc. (NYSE: HGR ) announced today that it plans ... for the second quarter ending June 30, 2009, on Tuesday, July ... , The conference call is scheduled to begin at 9:00 a.m., ... call 1-800-931-9710. In addition, a replay will be available until August ...
... Japan, June 23 A U.S. patent infringement lawsuit ... K.K., Hamamatsu Corporation, and Olympus America, Inc. The ... District Court for the District of Delaware, accuses products ... U.S. Patent Nos. 6,917,696; 7,457,446; and 7,518,652. , ...
... FamilyCord , one of the nation,s leading ... of the WBLI 106.1 Baby Shower event where 250 pregnant New ... of fun, prizes, and education on June 28. FamilyCord will ... to protect newborns against 70 life-threatening diseases. Leading up to the ...
... WASHINGTON, June 23 The National Medical Association (NMA) congratulates ... on their work with PhRMA to bring down health care ... "While the adoption of Medicare Part D has been a ... in the system," said Dr. Mohammad N. Akhter, Executive Director ...
, Journalists and other readers should disregard the news release, PHT Names VP to Lead Sales of A-Claim Payment Solution for Doctors, Hospitals, issued 23-Jun-2009. The release was transmitted prema...
Cached Medicine News:Health News:Sleep Disorders Linked to Arrhythmias 2Health News:U.S. Patent Infringement Lawsuit Filed by Aperio Technologies, Inc. 2
(Date:10/25/2014)... ARBOR, Mich. , Oct. 24, 2014 Advanced ... second quarter (ending September 26, 2014) financial results on Monday, ... will be released after the close of the market and ... discuss the results at 4:30 p.m. EDT on the same ... Richard Kurtz (CEO and Director), Rob Risser ...
(Date:10/25/2014)... Oct. 24, 2014  In 2008, two of Dr. ... of multiple controlled substances, on a regular basis, that ... that Dr. Gurney was practicing "all the time" while ... of his employees said that Dr. Gurney was prone ... patients." Dr. Gurney,s behavior became increasingly erratic ...
(Date:10/25/2014)... HILL, N.C. , Oct. 24, 2014 /PRNewswire/ ... to provide Medical Affairs leaders with a forum ... face. The consortium has developed a mechanism for ... discussions where leaders discuss key findings from the ... Practices has completed the analysis for the first ...
Breaking Medicine Technology:Advanced Photonix to Webcast Fiscal 2015 Second Quarter Earnings 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 3Strong Participation in Best Practices' Medical Affairs Consortium Survey 2
... company at the forefront of immunology treatment and research, is ... Washington, D.C. by reinforcing its commitment to improving the lives ... a large body of UCB data will highlight the potential ... Crohn,s disease. "ACG is an opportunity for UCB ...
... Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a ... be participating in the 2011 Credit Suisse Annual Health ... in Phoenix, Arizona on November 9, 2011, at 8:00 ... of the presentation can be accessed via Zimmer,s Investor ...
Cached Medicine Technology:UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 2UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 3Zimmer Holdings to Present at 2011 Credit Suisse Annual Health Care Conference 2
The AIA-600 II has become the new standard in benchtop immunoassay analyzers....
... The ACON PSA Semi-Quantitative Prostate Specific ... Blood/Serum/Plasma) are lateral flow tests in strip ... of Prostate Specific Antigen (PSA). The tests ... ng/mL cut-off values, and all come with ...
... Assess Functional Vision, Quality of Vision ... controls both target illumination and glare ... testing results. Day/Night testing with/without glare ... Standards and all ANSI standards. All ...
... is Recognized as a Valuable Tool ... by Early Eye Disease. Near Test ... 7 in (12.7cm x 17.78cm) Can ... Refractor,Distance Test F.A.C.T. 201: Size ...
Medicine Products: