From: Subject: Rezulin News Date: Mon, 21 Feb 2005 15:36:58 -0000 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_006B_01C5182B.2E4A78A0"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_006B_01C5182B.2E4A78A0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://web.archive.org/web/19991115190813/www.rezulin.com/release1.html Rezulin News
3Drezulinnews.com=20=20
3DRezulin=20
3Dwarner-lambert
3DParke-Davis
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3D""Rezulinnews = Home=20
3D""Prescribing Information =
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3D""Link to FDA = Site=20
WASHINGTON, D.C., March 26, 1999 =

NEW FACTS ABOUT REZULIN =

Data = presented=20 today by Warner-Lambert at a FDA Advisory = Committee=20 Meeting evaluating its type 2 diabetes therapy, = Rezulin,=20 pointed to these facts:=20

  • There have been 75 reported cases of=20 deaths/transplants in the U.S. mentioning the = liver.=20 The FDA has classified 26 of these cases, and = 9=20 transplant cases, as possibly or probably = related to=20 Rezulin. There have been an additional 8 cases = of=20 encephalopathy that the FDA considers to be = "possibly"=20 or "probably" related to Rezulin and all these = patients are alive. Approximately 750,000 = patients are=20 currently using Rezulin, while approximately = 1.6=20 million patients have taken Rezulin since it = was first=20 marketed in the U.S. in March 1997.=20
  • The reported rate of serious liver events = has=20 decreased substantially since the label = changes=20 despite an increase in the number of patients. = Specifically, the rate of liver-related death = and=20 transplants has declined in patients = initiating=20 therapy from approximately 1 in 36,000 in 1997 = to=20 approximately 1 in 57,000 since January 1, = 1998.=20
  • Importantly, the risk of serious liver = events=20 appears to peak between two and seven months = after=20 initiation of therapy and then declines.=20
  • Rezulin is an important addition to the = limited=20 armamentarium of therapies available to treat = type 2=20 diabetes. Clinical data presented showed that = Rezulin=20 resulted in significant glucose lowering in = type 2=20 diabetes patients treated with sulfonylurea,=20 sulfonylurea/metformin and insulin.=20
  • Rezulin can bring significant benefits to = type 2=20 patients in terms of blood sugar control that = may=20 enable patients for the first time to reach = their ADA=20 goals. In clinical trials, Rezulin has allowed = many=20 insulin taking type 2-diabetes patients to = reduce and=20 in some cases eliminate the need for daily = insulin=20 injections.=20
  • Rezulin's unique mechanism of action is=20 complementary to certain other medications and = appears=20 to preserve pancreatic function, which = translates into=20 better and longer-lasting control. =
In=20 addition, Robert Zerbe, MD, Senior Vice = President of=20 Clinical Research at Parke-Davis pointed out = that:=20
  • The benefit of Rezulin is complementary to = other=20 medications. In fact, in clinical studies, = type 2=20 patients poorly controlled on sulfonylurea and = metformin benefited by adding Rezulin to their = therapy.=20
  • Newer glitazone agents will need to have = the same=20 experience in the patient population as = Rezulin before=20 any authoritative conclusions can be made = about their=20 comparative risk-benefit ratios. Safety data = from=20 clinical trials in 5,000-7,500 patients is not = the=20 same as experience with 1.6 million patients = who have=20 received Rezulin since its introduction in the = U.S.=20 two years ago.
Rezulin may be used=20 concomitantly with a sulfonylurea or insulin to = improve=20 glycemic control. Rezulin, as monotherapy, is = indicated=20 as an adjunct to diet and exercise to lower = blood=20 glucose in patients with type 2 diabetes. = Rezulin should=20 not be used as monotherapy in patients = previously well=20 controlled on sulfonylurea therapy. For patients = inadequately controlled with a sulfonylurea = alone,=20 Rezulin should be added to, not substituted for, = the=20 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.=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 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 = clincial=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 the = potential=20 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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