FDA Issues Warning for Over-the-Counter Co... (rials involving small numbers of patient...)

FDA Issues Warning for Over-the-Counter Cold Remedy

Date:6/16/2009

rials involving small numbers of patients, we believe there have not been enough patients exposed in those trials to detect infrequent adverse events," she said.

According to Dr. Charles E. Lee, medical officer in the division of New Drugs and Labeling Compliance in CDER's Office of Compliance, the agency has received more than 130 reports from people using one of these zinc-containing products about the loss of a sense of smell, also known as anosmia.

"The loss of the sense of smell is potentially life-threatening and may be permanent," Lee said. "People without the sense may not be able to detect dangerous situations such as gas leaks, something burning in the house, or if food is spoiled before eating it. It also has a life-limiting effect, and can affect the livelihood of people in occupations where the sense of smell or taste is a crucial component."

Lee pointed out that, while the rate of adverse events seen here may not seem high, adverse events reports for over-the-counter drugs are historically low because consumers typically file their complaints with companies, not the FDA.

Until 2007, there was no requirement for makers of over-the-counter products to provide adverse event reports to the agency.

All reports of the latest problem have come from consumers and health-care providers, and Autor said the company has more than 800 adverse event reports related to the loss of sense of smell it has been asked to turn over to the FDA.

She declined to elaborate further on these reports, simply saying, "They have not been provided to the agency at this time."

Lee said the first reports of something amiss came in 1999, but seemed to speed up after 2004.

In 2006, Matrixx agreed to pay $12 million to settle several hundred lawsuits from consumers who claimed the zinc products had stripped them of their sense of smell. At the time, Matrixx said the settlements were not an admission of liabi
'/>"/>

0

GOOD

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:

Related Image:

FDA Issues Warning for Over-the-Counter Cold Remedy

(Date:5/23/2013)... (PRWEB) May 23, 2013 NDI ... funds and develops innovative neurodevice technologies, has launched ... (DBI). DBI will commercialize its groundbreaking technology ... (DBS) therapy for patients with Parkinson’s disease. ... Parkinson’s disease and generates more than $275 million ...

(Date:5/23/2013)... little was scientifically known about the human potential to ... people who are suffering in a way that motivates ... at the Center for Investigating Healthy Minds at the ... adults can be trained to be more compassionate. The ... Science , is the first to investigate whether training ...

(Date:5/23/2013)... connections in the brains of people affected by ... Peter Williamson, from Western University, to gain a ... important diseases. Dr. Williamson and colleagues have ... are disrupted in different psychiatric diseases. These ... Meeting, the annual meeting of the Canadian Association ...

(Date:5/23/2013)... DRE, Inc. is now offering the DRE ... upgrade older model DRE or BFW halogen headlights to ... , DRE and BFW customers can easily and affordably ... to LED with DRE’s American-made Xavier-C3 LED headlight conversion ... a bright, clean and even field of illumination with ...

(Date:5/23/2013)... MA (PRWEB) May 23, 2013 ... to announce the launch of Current Digital, a ... web development and digital marketing needs. Companies now ... a strategic business necessity. This can often leave ... creative strategy on preselected software platforms that they ...

Breaking Medicine News(10 mins):Health News:NDI Launches Deep Brain Innovations, LLC 2 Health News:NDI Launches Deep Brain Innovations, LLC 3 Health News:Study shows people can be trained to be more compassionate 2 Health News:Study shows people can be trained to be more compassionate 3 Health News:Study shows people can be trained to be more compassionate 4 Health News:Researchers identify networks of neurons in the brain that are disrupted in psychiatric disease 2 Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 2 Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 3 Health News:Verndale Launches Current Digital, a Technology Partner for Ad and Creative Agencies 2 Health News:Verndale Launches Current Digital, a Technology Partner for Ad and Creative Agencies 3

[0] NDI Launches Deep Brain Innovations, LLC [0] Study shows people can be trained to be more compassionate [0] Researchers identify networks of neurons in the brain that are disrupted in psychiatric disease [0] New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems [0] Verndale Launches Current Digital, a Technology Partner for Ad and Creative Agencies

... in French . ,OTTAWA (June ... Health, announced today that the Government of Canada is ... principal medical isotope affected by the current shutdown at ... isotopes in combination with imaging technologies to diagnose and ...

... Extending health insurance coverage to all children in the ... benefits that are greater than the costs, according to ... Public Policy. "Providing health insurance to all children ... Ho, chair in health economics at the Baker Institute ...

... Association for Molecular Pathology (AMP) today released the text ... Federal Coordinating Council for Comparative Effectiveness Research (CER) in ... on which to focus CER activities. "CER is ... makers who see it as a method to examine ...

... season will soon arrive in the Asian territories and culicine ... the virus that causes Japanese Encephalitis (JE), which kills 10-15,000 ... the largest provider of travel medical services in the U.S. ... FDA, and is ready for distribution in the United States. ...

... (Nasdaq: BMRN ) announced today that the temporary ... is not expected to have any impact on Aldurazyme supply ... fill at the Allston Landing facility was in September 2008. ... vialed inventory on hand, utilizes a second fill finish supplier ...

... CRYSTAL, Minn., June 16 On June 4, 2009, Herzing University ... to begin a Bachelor of Science in Nursing ... of preparation. , , A new medical lab, extensive ... few of the additions brought to campus to prepare for the ...

Cached Medicine News:Health News:Providing health insurance for US children would be cheaper than expected, study says 2 Health News:AMP urges inclusion of molecular diagnostic tests in comparative effectiveness research 2 Health News:AMP urges inclusion of molecular diagnostic tests in comparative effectiveness research 3 Health News:Monsoon Season will Bring Japanese Encephalitis 2 Health News:Temporary Production Interruption at Allston Landing Manufacturing Facility Has No Impact on Aldurazyme 2 Health News:Herzing University, Minneapolis Receives Board of Nursing Approval 2

Government of Canada supports research to help address medical isotope shortage Providing health insurance for US children would be cheaper than expected, study says AMP urges inclusion of molecular diagnostic tests in comparative effectiveness research Monsoon Season will Bring Japanese Encephalitis Temporary Production Interruption at Allston Landing Manufacturing Facility Has No Impact on Aldurazyme Herzing University, Minneapolis Receives Board of Nursing Approval

(Date:5/23/2013)... 23, 2013 MedVantx, Inc., the company that has ... announced today the Company has completed a major expansion ... pharmaceutical products and the upgrade of its systems to ... in its specialty home delivery pharmacy in ... pharmaceutical manufacturers, physicians, health systems and payors novel distribution ...

(Date:5/23/2013)... 2013 BioLife Solutions , Inc. (OTC:BLFS), a ... hypothermic storage and cryopreservation freeze ... media manufacturer , today announced its participation at the ... 2013 this week in London ... Dr. Aby J. Mathew, BioLife,s Senior Vice President and ...

(Date:5/23/2013)... TOKIO , 22. Mai 2013 ... Weiteren Ranbaxy), eine Tochtergesellschaft von Daiichi ... Sankyo), gab am 22. Mai die ... letzten Jahren ergriffen hat, um sich ... ( http://www.daiichisankyo.com/media_investors/media_relations/press_releases/index.html ). ...

Breaking Medicine Technology:MedVantx Achieves Significant Milestone of Managing $1.5B in Prescription Medications and Completes Facilities Expansion While Upgrading To Offer Current Good Manufacturer Practices (cGMP)-level Quality Systems in their Home Delivery Pharmacy 2 MedVantx Achieves Significant Milestone of Managing $1.5B in Prescription Medications and Completes Facilities Expansion While Upgrading To Offer Current Good Manufacturer Practices (cGMP)-level Quality Systems in their Home Delivery Pharmacy 3 BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress 2 BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress 3 Ranbaxy kündigt Verbesserungen bei Geschäftsstandards und Qualitätssicherungsinitiativen an 2

[0] MedVantx Achieves Significant Milestone of Managing $1.5B in Prescription Medications and Completes Facilities Expansion While Upgrading To Offer Current Good Manufacturer Practices (cGMP)-level Quality Systems in their Home Delivery Pharmacy [0] BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress [0] Ranbaxy kündigt Verbesserungen bei Geschäftsstandards und Qualitätssicherungsinitiativen an

... 2011 Reportlinker.com announces that ... is available in its catalogue: ... Acid Testing Market--New Product Development ... For Instrument and Reagent Suppliers ...

... NEW YORK, June 20, 2011 Reportlinker.com ... is available in its catalogue: ... 2011 http://www.reportlinker.com/p0558499/Top-Medical-Devices-and-Imaging-Technologies-2011.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Devices ... medical device and imaging technologies that have ...

Reportlinker Adds Global Nucleic Acid Testing Market--New Product Development Opportunities and Business Expansion Strategies For Instrument and Reagent Suppliers Reportlinker Adds Top Medical Devices and Imaging Technologies 2011

Supplied sterile in peel-open packages. Intended for one-time use....

... Used for catheter ... endourology procedures. Increased inner ... coils allows utilization of ... mandril while maintaining tip ...

Supplied sterile in peel-open packages. Intended for one-time use....

... access wire into the renal pelvis through a ... The mandril type shaft construction provides rigidity which ... (0.89 mm) diameter wire guide. The distal portion ... construction over the tapered mandril which provides tip ...

Medicine Products:

Fixed Core Curved Safe-T-J® Wire Guides - Standard (stainless steel)Amplatz Extra Stiff Wire Guides Fixed Core Straight Safety Wire Guides - Heavy Duty (PTFE coated)Cope Mandril Wire Guide