Excellent Hair Fall Treatment
Search: Look for:   Last 1 Month   Last 6 Months   All time
Home :: World

Experts challenge FDA approval for Alzheimer's drug

United States America,Health/Medicine,Science/Tech, Sun, 25 Mar 2012 IANS

Washington, March 25 (IANS) Experts have challenged approval for a new dose of a best-selling Alzheimer's drug by the FDA which not only "breached" its own "regulatory standard" but causes greater side-effects.




Lisa Schwartz and Steven Woloshin, both professors at the Centre for Medicine and the Media at The Dartmouth Institute for Health Policy contested the claims made for the new 23 mg dose of donepezilargue, described as a blockbuster drug for Alzheimer's.



They point to "a stunningly erroneous statement" in an advertisement aimed at doctors which claims that patients on the 23 mg dose "experienced important clinical benefit on both measures (cognition and overall functioning)."



Although the drug improved cognitive symptoms, the new dose caused more side-effects, including nausea and vomiting. Yet it will soon be under consideration for approval in 16 countries in Asia and South America, the BMJ-British Medical Journal reported.



The FDA and the manufacturer agreed that the 23 mg dose would be approved only if it was shown to be superior to the 10 mg dose on both a cognitive and a global functioning measure. Previously, the drug was only available in five mg and 10 mg doses, according to a Dartmouth Institute statement.



They said the new dose was approved "only over the objections of the FDA's medical and statistical reviewers" and that it offers "no meaningful added benefit, just more harm."



Alzheimer's is an awful disease, say the authors. "Sadly, the available drugs don't work well. But that is no excuse for manipulating vulnerable patients, desperate family members, and their doctors to use a product that is most likely to cause net harm."



King of Bhutan, the Bhutan Queen and Crown Prince meeting the PM Modi
PM Narendra Modi welcomes the King of Bhutan
PM Modi paying tributes at the portrait of Sardar Vallabhbhai Patel
People take part in the Run For Unity on the Rashtriya Ekta Diwas
PM Modi flagging off the Run For Unity on the Rashtriya Ekta Diwas
Post comments:
Your Name (*) :
Your Email :
Your Phone :
Your Comment (*):
  Reload Image




Excellent Hair Fall Treatment
Careers | Privacy Policy | Feedback | About Us | Contact Us | | Latest News
Copyright © 2015 NEWS TRACK India All rights reserved.