FDA warns bayer about aspirin

The FDA has warned Bayer about its aspirin claims. According to the AP, the FDA "scolded [Bayer] in two warning letters for never submitting proof that its pills -- Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage -- are effective in battling heart disease and osteoporosis."

Janet Woodcock of the FDA's Center for Drug Evaluation and Research said that if these aspirin-containing products are overused or not used properly, consumers can be at risk for internal bleeding and other issues. 

Treatments for these two diseases are required to be reviewed by a board of government scientists and cannot be sold over-the-counter.  

For such "combo pills," dietary supplements and drugs, to be legally marketed, they are subject to approval and generous regulation. 

What comments do you have about the weakness of the FDA and ways we might be able to improve it? Do you agree with me that potential of personal injury lawsuits provide a second line of protection for the consumers?

http://www.bailey-law.com/lawyer-attorney-1215486.html

Cefepime

FDA issued an early communication about new safety information and the request for additional data concerning  the risk of death in patients treated with cefepime. The May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) reported the increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. If someone has been prescribed this drug, I recommend that they contact their treating physician to discuss this breaking news.
Read the complete MedWatch 2007 Safety Summary including a link to the Early Communication Sheet regarding this ongoing safety review at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cefepime


http://www.bailey-law.com/lawyer-attorney-1215852.html

 

Aqua Dots recall

Spin Master Recalls Aqua Dots.  Small colorful beads can be made by children that then are used to construct objects. The idea is attractive and I'm sure many responsible adults bought the product to help their children in creative play. Unfortunately the small Aqua Dots are colorful and just the right size to be candy. The covering of the dots metabolizes into a drug often referred to as the "date rape" drug. It causes the children become confused, then suffer lose of muscle control. Depending on the amount consumed, it can cause amnesia, coma and even death.

Obviously our regulatory agencies are not providing enough protection for consumers and their children. Hopefully the Administration will not further compromise the last line of defense by what it refers to as "Tort Reform"--a code word for taking away the Constitutional right of consumers to sue for damages resulting from unreasonably dangerous products. 

http://www.bailey-law.com/lawyer-attorney-1215486.html