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Fetched from Food and Drug Administration Consumer Updates

FDA has received at least 73 reports of adverse reactions, including at least one death, related to the use of denture cleansers. Problems have occurred with both proper and improper use of these products.

FDA is asking manufacturers of denture cleansers to include a warning in the label about persulfates, which are known to cause allergic reactions in some people. Persulfates are used in most denture cleansers as part of the cleaning and bleaching process. The agency is also recommending that manufacturers consider appropriate alternatives to persulfates.

An allergic reaction to persulfates may not occur after the first use or even until after many years of use. Symptoms of an allergic reaction may not appear for several minutes or even hours after actual use. Symptoms may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure.

Other reactions may be due to misuse of denture cleansers. For example, some cleansers may list mouthwash as an ingredient, but consumers should never chew, swallow, or gargle with denture cleansers.

To reduce misuse of denture cleansers, FDA is also recommending that manufacturers improve the directions on the label. Labeling revisions are needed to make it clear that these products are meant to clean dentures in a container, not while still in the mouth. Some patients have gargled or swallowed denture cleansers, resulting in abdominal pain, vomiting, seizures, breathing problems, and low blood pressure. Dentures should be thoroughly rinsed with water before they are placed in the mouth.

For more information, read the rest of the story.

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Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

Read more here: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01791.html

I was wondering why I haven’t seen any Ambien commercials lately. According to the FDA,

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Here’s a list of some of the generic drugs approved by the FDA so far this year:

• Alendronate Sodium Tablets (Fosamax)
  Used for: Treating and preventing types of osteoporosis
  Originally marketed as: Fosamax, by Merck & Co.
  Date approved: Feb. 6, 2008
• Carvedilol Tablets (Coreg)
  Used for: Treating hypertension and heart failure
  Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
  Date approved: Sept. 5, 2007
• Cetirizine HCl Tablets (Zyrtec)
  Used for: Treating symptoms of allergies
  Originally marketed as: Zyrtec, by Pfizer
  Date approved: Dec.12, 2007
• Granisetron Tablets (Kytril)
  Used for: Preventing nausea and vomiting related to chemotherapy and radiation
  Originally marketed as: Kytril, by Roche
  Date approved: Dec. 31, 2007
• Oxcarbazepine Tablets (Trileptal)
  Used for: Treating certain kinds of seizures and epilepsy
  Originally marketed as: Trileptal, by Novartis
  Date approved: Oct. 9, 2007
• Pravastatin Sodium Tablets (Pravachol)
  Used for: Treating elevated cholesterol and preventing coronary events.
  Originally marketed as: Pravachol, by Bristol-Myers Squibb
  Date approved: Apr. 23, 2007
• Zolpidem Tartrate Tablets (Ambien)
  Used for: Treating insomnia
  Originally marketed as: Ambien, by Sanofi Aventis
  Date approved: Apr. 23, 2007

For more information, the FDA’s Office of Generic Drugs maintains a frequently-updated list of generic drug approvals.

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products’ label and labeling comply with the law.

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules.

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies’ Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres’ president and contained similar unproven statements claiming benefits for their products.

The FDA can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the federal Food, Drug, and Cosmetic Act or FDA regulations. The companies are also required to pay $1,000 per violation per day in the event they fail to comply with the consent decree.

All this news about alli and I’m wondering, how many people are actually considering taking this new drug? If you don’t mind, take a second and vote here, and pass this around to your friends and myspace buds.

If you’re viewing this in a feed reader, you may have to read this post to see the poll.

Have comments about alli? I’d love to see them - you can leave us comments below.