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FDA warns three companies to stop making unproven claims on mouth rinses

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to, Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).

These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

“It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.

The FDA actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.

To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.

Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days.  Failure to do so may result in seizure of the product, or other civil or criminal penalties.

For more information:

Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

 

Source: FDA

More informations to read:

Vacancy of Pharmacists in Badr al samaa hospitals, Oman

Badr Al Sama, is a fast growing hi-tech hospital group currently present at important cities like Al Khuwair, Sohar, Salalah, Al Khoud, & Barka in Sultanate of Oman, with sister concerns like Al Hilal Hospital in Bahrain and Shifa Jeddah Polyclinic in Saudi Arabia. This group now announced vacancies of Pharmacists, GP Doctors, Internist, Super Specialty Doctor, Staff Nurses, Lab Technicians and X-ray Tech for their various branches.

As they say in their website, all these posts requires minimum three years post qualification experience. Salary will not be a constrain for the right candidate.

Candidates will have to pass the respective examination conducted by the Ministry Of Health,Sultanate Of Oman.

No last dates mentioned in the website. The links were checked on 28/09/2010.

Interested candidates may forward their resume to :

E-mail : fayedamohamed@rediffmail.com, badralsamaa@omani.ws
Phone : +968 - 24799760, 24799761, 24799762, 24799763, 24799764.
Fax : +968 - 24799765.

 

Source: http://www.badralsamaahospitals.com

European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim – (Rosiglitazone)

The European Medicines Agency today recommended the suspension of the marketing authorizations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months.Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor.Doctors should stop prescribing rosiglitazone-containing medicines. Patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment.

AVANDIAThe current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on 9 July 2010 following the availability of new studies questioning the cardiovascular safety of the medicine. Since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review. Consequently, the use of rosiglitazone was restricted to a second-line treatment and contra-indicated in patients with heart failure or a history of heart failure when it was first granted a marketing authorisation as Avandia in 2000.

Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced.

The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.

The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks. The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.

Notes

  • Rosiglitazone was initially authorised as Avandia in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim.
  • The review of the marketing authorisations of Avandia, Avandamet and Avaglim was initiated on the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, following the publication of two studies on 28 June 2010. References for the two studies are as follows: Graham DJ et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA doi:10.1001/jama.2010.920. Nissen SE et al. Rosiglitazone revisited. An updated meta analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med doi:10.1001/archinternmed.2010.207.

Source: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/09/news_detail_001119.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

HOME USE DEVICES

A home use device is a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care provider in order to be used safely and effectively.

medical-device

Why is FDA's Center for Devices and Radiological Health (CDRH) interested?

Changes in health care have moved care from the hospital environment to the home environment.  In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.
As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.

CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. CDRH has been receiving an increasing number of adverse event reports about medical devices that are used in the home.

What can CDRH do?

CDRH wants to decrease the number of problems that occur in the home environment; but the issues are  complex. To be successful, the government agencies involved in home care need to collaborate with relevant stakeholders:

  • Manufacturers and Distributors
  • Health care professionals
  • Health care organizations
  • Accrediting bodies (Private or governmental bodies that grant recognition that an institution has met certain standards or requirements)

What information does this website provide?

This website will provide safety information and resources about medical products used in the home environment geared for a variety of audiences – consumers, patients, healthcare providers and manufacturers.

Courtesy: FDA

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