From Deseret News archives:
FDA lists 20 drugs that may pose risk
The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.
Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.
"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research. "If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."
One emerging concern that previously got little attention involved Tysabri, a newer, widely used multiple sclerosis drug. The FDA said it is investigating a potential link to skin melanoma, a dangerous cancer. Doctors in Boston had reported two cases of melanoma in Tysabri patients in a letter to the New England Journal of Medicine in February.
Tysabri suppresses the immune system, and it has also been linked to a rare kind of brain infection that is often fatal. Manufacturer Biogen Idec Inc. said it does not believe there is an increased risk of melanoma.
The FDA said drugs will be placed on the list based on reports it receives from hospitals, doctors and patients.
"What's new here is that we are telling the public really at the earliest stage what we are working on," said Dr. Gerald Dal Pan, head of the FDA's drug safety office. "I think the public told us, 'We want to know what you are working on.' And we are responding to that."
The list is not just a reflection of raw data, but more like what a police officer would call "probable cause." --> Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.
"Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list," said Dr. Paul Seligman, who is responsible for the FDA's safety communications.
Consumer advocates said the listing needs to be fleshed out.
Recent comments
i thought there was a list?
gen | Sept. 8, 2008 at 10:38 a.m.
Sarah would like this article. Although the headline is a nice...
List | Sept. 7, 2008 at 11:43 a.m.
HARRY SYGNOSKY:
IS THIS NEWSPAPER TRYING TO COVER UP FOR THE FEDS....
Anonymous | Sept. 7, 2008 at 11:36 a.m.
- BYU record with win 2:18 a.m.
- Bruins blast past Utah 12:36 a.m.
- Utah Jazz game at a glance 12:27 a.m.
- Knicks defeat winless Nets 12:23 a.m.
- Iginla powers Flames to win 12:20 a.m.
- Editorial: Hold the line on taxes 12:19 a.m.
- Secularists and religious arguments 12:19 a.m.
- Credit cards: Friend or foe? Depends 12:19 a.m.
- Gay rights, Blue Dogs 12:19 a.m.
- Bibby sprains ankle at New Orleans 12:19 a.m.
- Glenn Beck to enter politics?
- Can BYU throw vs. Air Force?
- Cougars cruise to victory in Hawaii
- Huntsman blasts media over trip
- Christian leaders not backing down
- Police link alcohol to murder
- TCU still has a chance
- BYU record with win
- Orem man acquitted in tot's death
- Religion cited in deportation fight
- Buttars wants to limit gay rights laws
192 - Palin plans tour stop in Utah
173 - Glenn Beck to enter politics?
129 - Palin's book shows she's unqualified
122 - Officer cleared in Cardall Taser case
103 - BYU cuts Women's Research Inst.
100 - Jazz finally win in San Antonio
98 - BYU record with win
95 - Utes knock off rival Aggies
93 - Huntsman pleased with Obama
87
I don't pretend to be an expert on global warming. I've met with...
Beck is extremely smart, he is selling books and is very popular on TV. All...
@Mick, the Federal Govt is run by corporations through contributions and...
Lets bond together and hope for a REAL celebration SUnday night, can hardly...
I was on the playground too and some teachers came out and called us all to...
B.Y.U. has been a consistent a top 25 ranked winner under Max Hall. Hall has...
Did Timp win four in a row or 4 in 4 years?
You have a lot of growing up to do, It seems like you have not cxperienced...
The proposed ethics law puts roughly the same burden on a legislator that a...
Hall ACTUALLY broke the all timme wins record vs WYO last week. I guess...
Sounds to me like Kraig Powell may be a candidate for resignation. So long,...

