Lilly smackdown - Cymbalta ads misleading | Arthritis Information
WASHINGTON (Reuters) -
Eli Lilly and Co made misleading
claims about its Cymbalta drug in a promotion to doctors about
its use in treating nerve-related pain, U.S. regulators said in
a letter released on Tuesday.
The promotion "is false or misleading in that it overstates
the efficacy of Cymbalta and omits some of the most serious and
important risk information associated with its use," the Food
and Drug Administration said in a letter to the company.
The FDA asked Lilly to immediately stop using the material
or any similar promotions, adding that the company made similar
claims for the drug in other promotions.
A Lilly representative could not immediately be reached for
comment.
Cymbalta, known generically as duloxetine, is approved for
treating depression, neuropathic pain and anxiety.
The FDA said the Lilly promotion, which it called a
"professional mailer," recommended Cymbalta only for the use of
managing pain associated with diabetic peripheral neuropathy.
The material overstated the drug's effectiveness by
suggesting that patients who took it experienced significantly
less pain interference with overall functioning, the FDA said.
"This has not been demonstrated by substantial evidence or
substantial clinical experience," said the agency's letter,
which was dated September 21 and posted on the FDA Web site on
Tuesday.
The FDA also said Lilly's promotion left out some important
risk information, including reports of sometimes-fatal
reactions if drugs such as Cymbalta are combined with medicines
known as monoamine oxidase inhibitors.
(Reporting by Lisa Richwine, editing by Gary Hill/Tim
Dobbyn)
Wow!
The FDA smacked somebody down???
WOW!
I think I've died and gone to heaven.
Pip
P.S. Thanks for posting this!
It's a miracle! And I'm not being facetious.
I wonder if this has anything to do with the new FDA drug safety act.
Holy smokes, the FDA actually doing something AFTER a drug has been approved? GoGo, it has to be the new legislation. I am of the understanding that the FDA had no legal way to control a drug once its approved via Phase IV, unless of course it finally kills X amount of patients and they sit up and take notice. The FDA has gone after drugmakers before for misleading ads... there was an incident several months ago where one of the big pharmas was ordered to pull some of their television ads. I can't remember what drug it was, but I do remember seeing the ads in question and thinking "what a crock of crap".
This month's Consumer Reports deconstructs the Requip ad (Restless Leg Syndrome). It says only three percent of adults actually suffer from it - how many times have you seen those ads???? I think it is just a sleeping pill.
Jasmine -
Do you know which SSRI? Got any links or other info I can chase down?
Pip
[QUOTE=Pip!]
Jasmine -
Do you know which SSRI? Got any links or other info I can chase down?
Pip
[/QUOTE]
They all have the potential. Those with a short half-life (like Paxil) are far more likely to cause it than those with a long half-life (like Prozac).
There's tons of info out there; start with the Wikipedia article:
http://en.wikipedia.org/wiki/SSRI_discontinuation_syndromeI think 3% is actually a pretty significant number. Only 1% suffer from RA, and look at all the drugs for that!
I wish I could post a link, Go-go, but I think you have to wait until it is off the newsstand? It is very interesting to see how the marketing played out, what else can cause it, what else can treat it, etc.
I have a 'thing' about Restless Leg Syndrome, after I was so sick with a stomach virus accompanied by severe leg pain. Not one but TWO doctors asked me the same question: "Is it like that leg thing they have those commercials for?"
I think you need to pay attention to the RA drug ads - you really only see them during the evening news, and only for the big guns. They make that money back. "Ask your doctor.." I can't because we don't have them in Canada!
They might be on cable (although I don't think so) but I don't have that either.
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