American authorities are allowing a drug used for irritable bowel
syndrome (IBS) back on the market, but with new restrictions. Lotronex
has been connected with seven deaths.
IBS is a condition charaterized by abdominal pain and discomfort
accompanied by alterations in bowel function, diarrhea, constipation or
a combination of both, typically over months or years. A majority of the
sufferers are women.
The Irritable Bowel Self-Help Support Group estimates 20 per cent of the
population has the condition.
"This is the first time a drug that has been withdrawn is being put back
on the market," Jeffrey Roberts told CBC News Online. Roberts is the
president and founder of the IBS Self Help Group which has 12,000
members worldwide. The association is located in Toronto.
Roberts was a key witness at the U.S. Food and Drug Administration
hearings on Lotronex.
Lotronex is used by five per cent of IBS patients. These are the people
who suffer the diarrhea form of the condition.
"I will now demand (the pharmaceutical company) press for access to this
drug in Canada," says Roberts.
Lotronex was pulled off the market by U.S. authorities in November 2000.
GlaxoSmithKline stopped producing the drug worldwide. At the same time,
it withdrew its application to have the drug approved by Health Canada.
Lotronex has never been available in Canada.
Side effects include restricted blood flow
Authorities were concerned about its side effects:
- ischemic colitis: restricted blood flow to the gut
constipation causing blockage and ruptured bowels
Roberts says an investigation found some of the patients experiencing
extreme side effects should not have been given the drug in the first
"One woman who died was bed-ridden and had
Alzheimers," points out Roberts. "She had no idea what was wrong with
woman who died was bed-ridden and had Alzheimers'
The U.S. program allows the drug to be prescribed by certain doctors
enrolled in a special program and given only to the sickest patients who
have failed other therapies.
Roberts wants the same kind of access in Canada. He says the drug could
potentially benefit about 150,000 people in Canada.
Many people in Walkerton, Ont. still suffer from IBS
from the contaminated water crisis in May 2000.
"We have to crawl before we can walk," says Roberts. "Everybody is going
to watch what happens in the U.S.
I predict it could get approval
in Canada in two years."
Roberts could face some road blocks. Some consumer groups in the U.S.
have said Lotronex only offers modest relief, that it hasn't been proven
to work for men and is dangerous for anyone with constipation.
Written by CBC News Online staff