What the FDA told the Makers of Detrol
Faithful readers will recall that I commented on the claims made for Detrol(r) in my second "
Empire" series article, first posted on May 16, 1999.It turns out the FDA had similar concerns. Unbeknownst to me, Pharmacia & Upjohn was notified in an FDA letter dated April 13, 1999, that the FDA considered their effectiveness claims to be exaggerated. They were accused of "omission of material facts", and "misleading claims" concerning the effectiveness of the drug in a paper brochure. FDA says that the drug was not "significantly" better than a placebo in one study, and this "material fact" was omitted from their advertisement.
The Detrol brochure also claimed, among other things, that Detrol was "selective" for the bladder instead of salivary glands (leading to the common complaint of dry mouth). The FDA noted that Detrol's research was based only on research "in cats", not "humans", and therefore, was "misleading".
So, there goes their effectiveness claims AND their side-effect superiority claims! So, what's left?
In fact, a search for "tolterodine" on the FDA website shows that Pharmacia & Upjohn was cited three times in 1998 for false or misleading claims about Detrol:
Apparently the FDA hasn't yet gotten around to evaluating websites, because similar problems exist there but have not been cited (yet).
Fortunately for Pharmacia & Upjohn, the FDA apparently does not monitor this (incontinence@onelist.com) mailing list, or they would find many additional things to complain about.
The tip for checking the FDA website came from the June, 1999 issue of "Worse Pills - Best Pills" newsletter of June, 1999. WP-BP is a Public Citizen/ Health Research Group publication, which has a website at
http://www.citizen.org/hrg. It's a Ralph Nader spin-off, edited by Sidney M. Wolfe, MD. Unfortunately, all you can do is order back issues, as $3, based on information on their website.WP-BP does complain about the high COST of Detrol --- $85.99 at a Washington DC drug chain, compared with a month's supply of generic oxybutynin at $30.79, a difference of $55.20 a month. But then, somebody's got to pay for those expensive TV ads about "overactive bladder"!
They also have a chart of Drugs that can cause urinary incontinence in the June, 1999 issue. Yep, everything from Urised and Lopressor to Prozac and Wellbutrin.
Because of the lack of long-range studies, WP-BP recommends against using any new drug until five years experience with side effects and complications have been accumulated. In the case of Detrol, that's May, 2003, they say.
But before you put your patients back on Ditropan XL, be sure to first check out what the FDA told Alza Corp on April 2, 1999.
[Referenced FDA documents are available, in PDF (Acrobat) format ONLY, on the FDA website. They are available under the Freedom of Information Act.]
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