Navigation Links
FDA Panel Finds OTC Cold Remedies Effective
Date:12/14/2007

Standard oral dose of phenylephrine works.

FRIDAY, Dec. 14 (HealthDay News) -- A decongestant in some of the most popular over-the-counter cold medicines is effective at its current dosage, a panel of U.S. health experts ruled Friday.

The panel of advisers to the U.S. Food and Drug Administration had heard day-long testimony on whether OTC cold medicines containing the decongestant phenylephrine really provide nasal congestion relief.

The medicines, which include Sudafed PE, Robitussin Night Relief Syrup, Tylenol Sinus and DayQuil capsules, all contain phenylephrine in 10-milligram doses.

On Friday, members of the FDA's Nonprescription Drugs Advisory Committee voted 11-1 that existing evidence supported the effectiveness of phenylephrine at that dose. In a second vote, 9-3, it urged further study of the decongestant's safety and effectiveness at higher doses. The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Industry experts applauded the panel's vote.

Linda A. Suydam, president of the Consumer Healthcare Products Association, said in a prepared statement that the vote "reaffirms the results of numerous scientific studies and decades of consumer experience. CHPA and the leading makers of OTC cough, cold, and allergy medicines containing phenylephrine are committed to adding to the existing body of evidence currently supporting the safety and efficacy of phenylephrine."

She added, "Our goal is to continue to provide consumers with safe and effective therapies, and we are committed to working with FDA to ensure that the scientific data further supports this goal."

CHPA's members include Bayer, GlaxoSmithKline, Perrigo. and most other makers of over-the-counter medicines, according to the Associated Press.

The issue had been brought to the FDA by University of Florida researchers whose review of 14 studies on phenylephrine suggested that pill and syrup versions of these medicines offered users no real relief. The researchers had petitioned the FDA to investigate the matter and also examine the possibility of requiring higher doses that would work.

Drug companies have recently turned to phenylephrine as a replacement for another decongestant, pseudoephedrine, to comply with a 2006 U.S. law requiring that products containing pseudoephedrine be sold from behind the counter. The law was designed to prevent these medications from being bought in bulk and turned into methamphetamine.

On the academics' side, according to the AP, was drug maker Schering-Plough, which had decided not to reformulate its Claritin line of decongestants, which contain pseudoephedrine.

"If you have a stuffy nose, and you take an over-the-counter product containing phenylephrine, you will still not be able to breathe through your nose after you take it. That's the bottom line," Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida, contended before the advisers met.

Hendeles had led the review, which was published in the July 2006 issue of the Journal of Allergy and Clinical Immunology, and he had petitioned the FDA to boost the maximum allowable dose of phenylephrine in oral decongestants to 25 milligrams, which he believes may be more effective.

"There needs to be a dose-response study where you look a 10-, 25- and 50-milligram doses and determine what dose would give you a relief of your stuffy nose without side effects," he said.

But one expert worried that boosting doses of phenylephrine might come at a price.

"No medicine ever has been shown beyond the shadow of a doubt to be effective for the common cold," noted Dr. Bruce Barrett, an associate professor of family medicine at the University of Wisconsin in Madison. "The main problem with decongestants is that they stimulate the heart and increase blood pressure."

Barrett is concerned that if the dose of phenylephrine is too high, it will result in increased blood pressure and other cardiac side effects.

"If applied to tens of thousands of people, you will get cardiac arrhythmias, some of them fatal," Barrett said. "The FDA may need to see studies of tens of thousands of people to see the severity of side effects, and the drug companies may not have the money to do that."

More information

For more about colds and flu, visit the American Lung Association.



SOURCES: Leslie Hendeles, Pharm.D., professor, pharmacy and pediatrics, University of Florida, Gainesville; Bruce Barrett, M.D., Ph.D., associate professor, family medicine, University of Wisconsin, Madison; Dec. 14, 2007, statement, Consumer Healthcare Products Association; Associated Press


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

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 Finds OTC Cold Remedies Effective
(Date:7/24/2017)... ... 2017 , ... SignatureCare Emergency Center is looking to award their ... to a deserving student. Get your applications in now as the deadline is ... Castillo who is a nursing student at Prairie View A&M University with a 3.45 ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... Oakland, California effectively destroyed the construction site and threatened numerous homes and businesses ... 7th article on NBCLosAngeles.com. Los Angeles Area consulting firm Fire Protection ...
(Date:7/24/2017)... CLARA, CA (PRWEB) , ... July 24, 2017 , ... ... and financial organizations, today announced it has partnered with WALLIX to expand ... Special Publication 800-171 . , There are a number of ways to address the ...
(Date:7/24/2017)... California (PRWEB) , ... July 24, 2017 , ... ... of autologous fat (adipose) transfer systems announces the issuance of United States Patent ... patent) for its adipose filtration technology. The '398 and '324 patents cover ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... sleep management solution focused on delivering end-to-end sleep health care at scale, ... Recent literature shows that adherence rates for positive airway pressure (PAP) therapy, the ...
Breaking Medicine News(10 mins):
(Date:7/21/2017)... and EDMONTON, Alberta , July ... and the University of Alberta in ... in Nature,s partner journal, Schizophrenia 1 , demonstrating ... instances of schizophrenia with 74% accuracy. This retrospective ... of specific symptoms in schizophrenia patients with significant ...
(Date:7/21/2017)... , July 21, 2017  Endo International plc (NASDAQ: ... a comprehensive review of its manufacturing network, the Company ... distribution facilities in Huntsville, Alabama . ... place over the next 12 to 18 months. The ... by declining volumes of commoditized products and these restructuring ...
(Date:7/20/2017)... , July 20, 2017  Prime Therapeutics LLC (Prime) ... Gavras , M.D., following today,s Institute for Clinical and Economic ... on the effectiveness and value of abuse-deterrent formulations (ADF) ... the policy roundtable at the meeting. ... a material cost benefit to the use of abuse-deterrent formulations ...
Breaking Medicine Technology: