Rezulin News

From: Subject: Rezulin News Date: Mon, 21 Feb 2005 15:31:41 -0000 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0041_01C5182A.7109FC20"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_0041_01C5182A.7109FC20 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://web.archive.org/web/19990823055316/www.rezulin.com/release3.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 =

Warner-Lambert Pleased By FDA = Advisory=20 Committee
Recommendation On Rezulin=20

The=20 Endocrinologic and Metabolic Drugs Advisory = Committee to=20 the U.S. Food and Drug Administration today = reviewed the=20 most recent data on the safety and efficacy of = Rezulin=20 (troglitazone) and reaffirmed its benefit for = most type=20 2 diabetes patients. The Committee members were=20 supportive of its use in combination with = metformin and=20 sulfonylureas. Committee members were divided on = whether=20 the benefit of Rezulin as monotherapy outweighed = the=20 risk with the current labeling.=20

"Warner-Lambert is pleased that the FDA and = their=20 Advisors have given us the opportunity to = provide a=20 rational analysis of the risks and benefits = associated=20 with Rezulin. Now we can finally put to rest the = controversy and inaccuracies that have been = reported for=20 the past several months," said Dr. Robert Zerbe, = senior=20 vice president, Worldwide Clinical Research and=20 Development. "Warner-Lambert will continue to = work with=20 the FDA to further refine the label." He added = that,=20 "Patients and physicians can feel confident = about the=20 value of Rezulin -- this is an important day for = type 2=20 diabetes sufferers."=20

Rezulin offers important benefits for the = treatment=20 of type 2 diabetes having been used by more than = 1.6=20 million patients. Rezulin is used principally in = combination with other type 2 diabetes agents, = with only=20 15 percent of its use in monotherapy. Though = Rezulin=20 provides benefits as a monotherapy, the majority = of type=20 2 patients eventually manage their disease with = a=20 combination of medications, known as rational=20 combination therapy.=20

In clinical trials, Rezulin enabled many = patients to=20 reach their ADA goals for blood glucose control. = In=20 addition, many patients taking insulin were able = to=20 reduce or eliminate their daily insulin = injections. With=20 a progressive disease such as diabetes, ongoing=20 management is fundamental to the long-term = health of the=20 patient.=20

Obtaining the new combination indication = would=20 provide physicians an important new therapeutic = option=20 for the management of difficult-to-treat = patients prior=20 to initiating insulin therapy. The majority of = diabetes=20 patients in the U.S. are under some form of = combination=20 therapy regimen. Lastly, as the data presented = by=20 Warner-Lambert at the Advisory Committee = suggest,=20 current label requirements for liver enzyme = monitoring=20 have been associated with a reduction in the = rate of=20 reported adverse liver events.=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 = hepatocellular=20 events have been reported during marketed use = (see=20 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. These = events=20 have occurred after both short- and long-term = treatment.=20

Although liver enzyme monitoring cannot = completely=20 eliminate the potential for serious liver = problems, it=20 should help reduce the risk.=20

Rezulin patients should have liver function = enzymes=20 tested on a regular basis. Serum transaminase = levels=20 should be checked at the start of therapy, = monthly for=20 the first eight months of therapy, every two = months for=20 the 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 exceed the = potential=20 risks.=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 (eg congestive heart = 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

Contacts: = Carol=20 Goodrich (973) 540-3620 =
Christy=20 = Davis (973)=20 = 540-2145

=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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