Rezulin News

From: Subject: Rezulin News Date: Mon, 21 Feb 2005 15:41:14 -0000 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_008D_01C5182B.C6CC3820"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1441 This is a multi-part message in MIME format. ------=_NextPart_000_008D_01C5182B.C6CC3820 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://web.archive.org/web/19990823050052/www.rezulin.com/bkgrnder3.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 =

The Postmarketing Surveillance = System=20

Ongoing Drug=20 Safety Review and Patient Protection=20

Established by Congress as part of the Food, = Drug and=20 Cosmetic Act amendments of 1962, the = Postmarketing=20 Surveillance System is a U.S. Food and Drug=20 Administration (FDA) program that depends upon = voluntary=20 reporting of adverse incidents by physicians,=20 pharmacists, and mandatory reporting by = pharmaceutical=20 companies - who file more than 90 percent of the = reports.=20

The term "postmarketing surveillance" refers=20 specifically to the ongoing safety monitoring = that=20 occurs throughout the life of a drug following = approval=20 by the FDA. Postmarketing surveillance is an = extension=20 of the testing that begins with the initial = research on=20 a drug compound, extends through clinical = trials, and=20 continues throughout the decades-long life cycle = of a=20 drug.=20

Regulations require that drug manufacturers = report=20 any adverse drug experience to the FDA that = results in:=20

Death, regardless of cause=20

A life-threatening episode=20

Inpatient hospitalization or prolongation = of=20 existing hospitalization=20

A persistent or significant disability or=20 incapacity=20

A congenital anomaly or birth defect=20

Important medical events

If a serious adverse event is = unexpected -=20 that is it is not cited as a possibility in a = drug's=20 labeling - it must be reported to the FDA within = 15=20 days, regardless of how long the drug has been = on the=20 market. If an adverse event is expected - = that=20 is, there is already a label warning - it must = be=20 reported within 90 days if it occurs during the = first=20 two years of the drug's market life, and = annually=20 thereafter. Non-serious adverse events, = those=20 that don't fall into the definition above but = occur=20 within the first two years of the drug's life, = must be=20 reported within 90 days and annually thereafter. =

When postmarketing surveillance identifies a = serious=20 adverse event, the manufacturer may communicate=20 additional information about the drug to = physicians and=20 patients, and revise the prescribing information = in the=20 package insert.=20

Parke-Davis, Rezulin and Postmarketing=20 Surveillance=20

Parke-Davis, like all other pharmaceutical = companies,=20 conducts continuous postmarketing surveillance = following=20 FDA approval. In the case of Rezulin, = Parke-Davis=20 reported information it received about serious=20 liver-related adverse events affecting a small = subset of=20 patients to the FDA, and in conjunction with the = FDA,=20 revised the product labeling to require patient = liver=20 enzyme monitoring. Since that time, the rate of = reported=20 serious liver-related adverse events has fallen=20 dramatically.=20

Like many pharmaceutical companies, the Drug = Safety=20 Department of Parke-Davis is composed of a = highly=20 trained staff of physicians, statisticians,=20 epidemiologists, medical reviewers and data = entry=20 personnel whose primary charge for all the drugs = Parke-Davis manufactures is to receive reports = from=20 physicians, follow-up and evaluate adverse = events, and=20 then report them to the FDA. Parke-Davis has = taken an=20 added step: faxing overnight to the FDA = any=20 reported adverse liver events with Rezulin = patients. The=20 Drug Safety Department is assisted by an = extensive sales=20 force, drug information specialists, and company = personnel who have day-to-day contact with = physicians=20 and relay back to the Drug Safety Department any = unusual=20 events that may be occurring with any = Parke-Davis drug.=20

The Importance of Postmarketing = Surveillance=20

When serious adverse events are reported to = the FDA=20 it indicates that the Postmarketing Surveillance = System=20 is functioning properly. Postmarketing = surveillance=20 enables drug manufacturers and the FDA to = identify=20 adverse events so uncommon they do not arise = during=20 clinical trials involving a few thousand = patients, but=20 may turn up after a medication is used by = hundreds of=20 thousands, if not millions of patients suffering = from=20 numerous different complications, and taking any = of=20 hundreds of additional medications.=20

The Postmarketing Surveillance System = provides the=20 FDA and pharmaceutical manufacturers with the = ongoing=20 information required to fine-tune drug labeling = warnings=20 and prescribing information.=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. 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 enzyme = monitored=20 regularly. Serum transaminase levels should be = checked=20 at the start of therapy, monthly for the first = eight=20 months of therapy, every two months for the = remainder of=20 the first year of Rezulin therapy, and = periodically=20 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 risks=20 to the fetus.=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 =

=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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