Rezulin News

From: Subject: Rezulin News Date: Mon, 21 Feb 2005 15:33:46 -0000 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_005A_01C5182A.BB4CE900"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_005A_01C5182A.BB4CE900 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://web.archive.org/web/19990823053452/www.rezulin.com/release2.html Rezulin News

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Rezulinnews = Home=20

Prescribing Information =

Citizens'=20 Petition Response

Link to=20 Warner-Lambert Site

Link = to ADA=20 Site

Link to FDA = Site=20

WASHINGTON, D.C., March 26, 1999 =

REZULIN: FICTION VS. FACT =

There have=20 been false statements made over the past several = months.=20 This document serves to clarify fact from = fiction.=20

Fiction
All diabetes drugs have = some=20 risk, but in terms of mortality, none of them = comes=20 close to Rezulin. Safer drugs are nearing = approval.=20

Fact
Currently all approved oral=20 antidiabetic agents have been associated with = reports of=20 fatal adverse events. However, it is = inappropriate to=20 make comparative claims without data from = comparative=20 head-to-head clinical studies.=20

Fiction
Almost all of the=20 Rezulin-related deaths from liver toxicity have = been=20 reported after the latest label change, = reflecting the=20 fact that the warnings are clearly inadequate to = prevent=20 the increasing amount of serious often fatal = liver=20 damage in patients using Rezulin.

Fact
First, most Rezulin-related = deaths=20 from liver toxicity were before the last label = change.=20 The rate of reported serious liver events has = decreased=20 substantially since the label changes despite an = increase in prescriptions. Specifically, the = rate of=20 liver-related death and transplant has declined = from=20 approximately 1 in 36,000 in 1997, to = approximately 1 in=20 57,000 in patients initiating therapy since = January 1,=20 1998.=20

Fiction
It is likely there are = hundreds=20 of deaths right now that have not been = reported.=20

Fact
There have been 75 reported = cases of=20 liver-related deaths/transplants for patients = taking=20 Rezulin in the U.S. The FDA has classified 26 of = these=20 as possibly or probably related to Rezulin, and = an=20 additional nine cases of transplant as possibly = or=20 probably related to the drug. There have been an = additional eight cases of encephalopathy that = are=20 classified as "possibly" or "probably" related = to=20 Rezulin and all these patients are alive.=20

It is very unlikely that these events could = be=20 materially underreported given their severity, = given the=20 thoroughness with which diabetics are monitored = and=20 given the publicity this matter has received.=20

Fiction
There are currently nine = other=20 antidiabetes drugs on the market; there is no = need for a=20 drug like Rezulin to be on the market.=20

Fact
There are four therapeutic = categories=20 and not all of these categories are appropriate = for all=20 type 2 patients. In addition, all antidiabetic = therapies=20 on the market are associated with fatal adverse = events.=20

Unlike most diabetes drugs, which stimulate = the=20 pancreas to produce more insulin, Rezulin breaks = down=20 resistance to the body's own insulin. Rezulin = can bring=20 significant benefits to patients in terms of = blood sugar=20 control that may enable many patients, for the = first=20 time, to reach their ADA goals. In clinical = trials,=20 Rezulin allowed many insulin-taking type 2 = diabetes=20 patients to reduce or, in some cases, eliminate = the need=20 for daily insulin injections.=20

Fiction
No doctor in his right = mind=20 would use this drug.=20

Fact
Since its introduction, the = number of=20 patients prescribed Rezulin by physicians has = increased=20 and the product continues to be one of the most=20 prescribed antidiabetics on the market.=20

Fiction
Rezulin is not on the = market=20 anywhere else but the United States.=20

Fact
Rezulin is currently on the = market in=20 13 countries. Glaxo Wellcome who owns the = marketing=20 rights of troglitazone in Europe, has yet to = apply for a=20 new drug application in any European country = other than=20 the United Kingdom.=20

Rezulin may be used concomitantly with a = sulfonylurea=20 or insulin to improve glycemic control. Rezulin, = as=20 monotherapy, is indicated as an adjunct to diet = and=20 exercise to lower blood glucose in patients with = type 2=20 diabetes. Rezulin should not be used as = monotherapy in=20 patients previously well controlled on = sulfonylurea=20 therapy. For patients inadequately controlled = with a=20 sulfonylurea alone, Rezulin should be added to, = not=20 substituted for, the sulfonylurea.=20

Management of type 2 diabetes should also = include=20 diet control, weight loss and exercise. Rezulin = should=20 not be used in type 1 diabetes or for the = treatment of=20 diabetic ketoacidosis.=20

Rare cases of severe idiosyncratic adverse=20 hepatocellular events have been reported during = marketed=20 use (see Hepatic boxed WARNING in the full = prescribing=20 information). The hepatic event is usually = reversible,=20 but very rare cases of hepatic failure, leading = to death=20 or liver transplant, have been reported. Adverse = liver=20 events have occurred after both short- and long- = term=20 treatment. Although liver enzyme monitoring = cannot=20 completely eliminate the potential for serious = liver=20 problems, it should help reduce the risk.=20

Rezulin patients should have their liver = enzymes=20 monitored regularly. Serum transaminase levels = should be=20 checked at the start of therapy, monthly for the = first=20 eight months of therapy, every two months for = the=20 remainder of the first year of Rezulin therapy, = and=20 periodically thereafter.=20

In clinical studies, Rezulin was generally = well=20 tolerated. The incidence of withdrawals during = clinical=20 trials was similar for patients treated with = placebo or=20 Rezulin (4%). The most common adverse events = included=20 infection (22% placebo vs 18% Rezulin), headache = (11%=20 placebo vs 11% Rezulin), and pain (14% placebo = vs 10%=20 Rezulin).=20

In premenopausal anovulatory patients with = insulin=20 resistance, Rezulin treatment may result in = resumption=20 of ovulation. These patients may be at risk for=20 pregnancy. Rezulin should not be used during = pregnancy=20 unless the potential benefits outweigh potential = risk.=20

Although an increase in plasma volume of 6% = to 8%=20 compared with placebo was observed in a 6-week = study of=20 troglitazone treatment in 24 normal volunteers, = there=20 was no increased incidence of adverse events = potentially=20 related to volume expansion (e.g. congestive = heart=20 failure) in controlled clinical trials for = Rezulin.=20 Patients with New York Heart Association (NYHA) = Class=20 III and IV cardiac status were not studied = during=20 clinical trials; therefore, Rezulin is not = indicated in=20 patients with NYHA Class III or IV cardiac = status unless=20 the expected benefit is believed to outweigh the = potential risk.=20

Please see accompanying full prescribing = information=20 for Rezulin.=20 =

=A91999 = Warner-Lambert=20 Company. All rights reserved. Use of and access to the information on = this site=20
are subject to the terms and conditions set out in the Agreement to = use the=20 Warner-Lambert Company Web sites.
Please review this Privacy Statement = before=20 proceeding.
Created by Nethod, = LLC. on=20 behalf of the Warner-Lambert Company.
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