Navigation Links
FDA Issues Warning for Over-the-Counter Cold Remedy
Date:6/16/2009

Zicam nasal products can cause loss of smell, officials stress

TUESDAY, June 16 (HealthDay News) -- U.S. health officials on Tuesday warned consumers to stop using Zicam nasal cold remedy products because they can cause the loss of a sense of smell.

The specific products contained in the warning include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids' Size.

"These products claim to reduce the duration of the common cold and severity of cold symptoms," Deborah M. Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration, said during a morning teleconference Tuesday. "Consumers should stop using these products immediately."

The kids' products have been discontinued, but consumers may still have them in their households and are advised to discard or return them, officials said.

The products' manufacturer, Matrixx Initiatives, also received a warning letter and "must provide FDA with a plan on how it will remove existing inventory from the marketplace," Autor said.

"We have asked Matrixx in a warning letter to stop marketing the products, and we intend to work with them to address the products on the market and, at the same time, warn consumers to stop using and discard or return them," Autor continued. "We expect to hear a plan from the company."

According to Autor, the products have been marketed as homeopathic remedies and, therefore, have not needed FDA approval as long as the company complied with certain labeling and manufacturing requirements.

Now, the FDA is essentially asking Matrixx to take the unusual step of recalling the product, and then filing for new drug approval.

"The next step is for the company to come in and seek FDA approval if they want to continue marketing the products," Autor said.

"While the company has done t
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. PowerBar Issues Open Call for 2008-2009 PowerBar Team Elite(TM) Athlete Sponsorship Program
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
4. American Red Cross Issues Blood Supply Alert
5. OSHA Issues Draft Ergonomics Guidelines on Preventing Musculoskeletal Injuries in Shipyards
6. New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
7. National Quality Forum Issues First Consensus Standards for the Treatment of Substance Use Conditions
8. Audio: New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
9. Dallas-Area Transplant Meeting Puts Spotlight on Key Issues
10. Elder Care Author Doctor Marion Launches Second National Tour to Raise Awareness About Aging & Elder Care Issues in America
11. California State PTA Issues Statement Regarding Presidents Veto of SCHIP Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Issues Warning for Over-the-Counter Cold Remedy 
(Date:4/14/2014)... orphaned by HIV/AIDS in South Africa may provide insight ... behavior issues in other areas of the world, which ... that could lead to successful interventions. , A ... United Nations mentions that due to the HIV/AIDS pandemic, ... African, children are at an increased risk for mental ...
(Date:4/14/2014)... A new study shows that moderate to severe ... risk of stroke, cancer and death. , Results of ... to severe obstructive sleep apnea were four times more ... times more likely to have a stroke (HR = ... (HR = 3.4), and 2.5 times more likely to ...
(Date:4/14/2014)... Dallas study involving serious youth offenders, the answer to one ... seven years: "How long do you think you,ll live?", According ... offending over time., Author Dr. Alex Piquero said the study ... of them offend at very high rates and commit more ... much later in life offend much less., "In a lot ...
(Date:4/14/2014)... with symptoms increasing dramatically during some of the most important ... has found. , Depressive symptoms increased on average by 68 ... young men, who were around 25 years old when they ... their children. The results of the study were published April ... is the first to identify when young fathers are at ...
(Date:4/14/2014)... Lower weight babies and babies who aren,t breastfed ... risk of developing chronic inflammation and related health ... study. , "There were good reasons to hypothesize ... inflammation in adulthood," says Thomas McDade (Northwestern University), ... in the Child & Brain Development program. "It ...
Breaking Medicine News(10 mins):Health News:Researchers identify children with emotional behavior difficulties 2Health News:Researchers identify children with emotional behavior difficulties 3Health News:Study links severe sleep apnea to increased risk of stroke, cancer and death 2Health News:UT Dallas study: Youth who fail to envision future commit more crimes 2Health News:Young dads at high risk of depression, too 2Health News:Low birth weight, less breastfeeding create later health risks 2
... for doctors. Could they work for patients, too? Could ... preventive health services more? In some cases, yes, according ... in Australia, and colleagues. Their work, looking at why ... to change risky health behaviors, indicates that incentives are ...
... Can dementias and mild cognitive impairment be influenced in ... the subject of a study reported by Thorleif Etgen ... rzteblatt International (Dtsch Arztebl Int 2011; 108[44]: 743-50). ... mild cognitive impairments and even dementia, which means that ...
... a woman or a parent and a baby, we can still ... related. How do we know that people are part of a ... of Vision increases our understanding of the brain,s ability to ... to see the family resemblance between faces that have some underlying ...
... with coronary artery disease were almost three times as ... treatment to arterial plaque than their White European counterparts, ... the International Journal of Clinical Practice . They ... and require urgent treatment. Researchers carried out a ...
... with dexpramipexole a novel drug believed to prevent ... most of a cell,s energy appears to slow ... (ALS). Promising results of a phase 2 trial ... Medicine. Some preliminary results of the study were ...
... , SUNDAY, Nov. 20 (HealthDay News) -- A good night,s ... a new study. The findings suggest that age-related brain ... the memory problems that can occur in older adults, the ... older adults who learned how to navigate through a series ...
Cached Medicine News:Health News:It pays to be healthier 2Health News:New research sheds light on how we see family resemblance in faces 2Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 2Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 3Health News:Novel ALS drug slows symptom progression, reduces mortality in phase 2 trial 2Health News:Novel ALS drug slows symptom progression, reduces mortality in phase 2 trial 3
(Date:1/15/2014)... NEW YORK , Jan. 15, ... a new market research report is ... Global Markets and Technologies ... Focus on Routes of Administration ... STUDY OBJECTIVES A ...
(Date:1/15/2014)... 2014  A novel wearable injector slightly larger than ... painless for patients to self-inject prescription drugs in the ... disorders, including cancer, blood diseases, autoimmune deficiencies, and genetic ... is expected to grow to $220B by 2018, according ... new type of injector that does not exist today ...
(Date:1/14/2014)... 2014  Luminex Corporation (Nasdaq: LMNX ) ... the fourth quarter of 2013 on Monday, February 3, ... for release after the close of trading. ... hold a conference call to discuss the operating highlights ... months ended December 31, 2013 on February 3, 2014, ...
Breaking Medicine Technology:Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3
... PRXL ), a leading global biopharmaceutical services ... one of two strategic partners by UCB, a global ... PAREXEL will work with UCB to drive innovation ... and cost effectiveness. The agreement is effective ...
... Reportlinker.com announces that a new market research ... The Outlook for Pharmaceuticals ... http://www.reportlinker.com/p0203103/The-Outlook-for-Pharmaceuticals-in-Central--Eastern-Europe.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication ... Europe is estimated at US$63.6 billion at ...
Cached Medicine Technology:UCB and PAREXEL Sign Strategic Partnership Agreement 2UCB and PAREXEL Sign Strategic Partnership Agreement 3UCB and PAREXEL Sign Strategic Partnership Agreement 4The Outlook for Pharmaceuticals in Central & Eastern Europe 2The Outlook for Pharmaceuticals in Central & Eastern Europe 3The Outlook for Pharmaceuticals in Central & Eastern Europe 4
... System supports approaches to Admitting/Discharge/Transfer ... record keeping functions using a ... facilities and cut across institutional ... community clinics, physician, agency, nursing ...
... Dairylands Clinical Information Management ... suite of integrated applications ... departments and automate administrative ... The applications allow organizations ...
... include a Patient Face Sheet, ... many as six custom tabs, ... information is important for you ... Import Manager utility lets you ...
... WEBeDoctor® Physician-office® is an ... physicians, (Solo practice, group ... to complete their normal ... It is a front ...
Medicine Products: