EMERGENCY!!!!Re: [Lyme-aid] Allergic reactions?

[Guest guest]

does anyone have elisabeth's phone number???

please call her and tell her that the rash could be a life threatening

reaction to lamictal.

pleas, if you do this let me know.

i am terrified.

kay

FDA WARNING!

http://www.fda.gov/medwatch/safety/1997/lamict.htm

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This is the retyped text of a letter from Glaxo Wellcome Inc. Contact the

company for a copy of any referenced enclosures.

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IMPORTANT

DRUG

WARNING

March 1997

Dear Health Care Professional:

Glaxo Wellcome would like to advise you of new warnings in the labeling for

LAMICTAL (lamotrigine) Tablets, an antiepileptic drug indicated for

adjunctive therapy of partial seizures in adults with epilepsy. These new

warnings pertain to reports of severe, potentially life-threatening rash,

including s- syndrome, and rarely, toxic epidermal necrolysis,

reported in association with the use of LAMICTAL.

The revised labeling now includes a boxed warning which emphasizes that

LAMICTAL is not indicated for use in patients below the age of 16 years.

Specifically, reports from clinical trials suggest that as many as 1 in 50

to 1 in 100 pediatric patients treated with LAMICTAL develop a potentially

life-threatening rash, as compared with a rate of approximately one in every

thousand adults.

These revisions to the labeling, agreed in consultation with the US Food and

Drug Administration, reflect additional information obtained through

worldwide clinical experience in an estimated 600,000 patients and the

ongoing Glaxo Wellcome clinical development program for LAMICTAL.

Other related changes have been made in the INDICATIONS, WARNINGS,

PRECAUTIONS, ADVERSE EVENTS, and DOSAGE and ADMINISTRATION sections of the

labeling. A full copy of the revised package insert is enclosed; the major

changes are summarized below:

A boxed warning has been added, as follows:

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SEVERE, POTENTIALLY LIFE-THREATENING RASHES HAVE BEEN REPORTED IN

ASSOCIATION WITH THE USE OF LAMICTAL. THESE REPORTS, OCCURRING IN

APPROXIMATELY ONE IN EVERY THOUSAND ADULTS, HAVE INCLUDED STEVENS-JOHNSON

SYNDROME (SJS), AND RARELY, TOXIC EPIDERMAL NECROLYSIS (TEN). RARE DEATHS

HAVE BEEN REPORTED, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE

ESTIMATE OF THE RATE.

THE INCIDENCE OF SEVERE, POTENTIALLY LIFE-THREATENING RASH IN PEDIATRIC

PATIENTS, HOWEVER, IS VERY MUCH HIGHER THAN THAT REPORTED IN ADULTS USING

LAMICTAL; SPECIFICALLY, REPORTS FROM CLINICAL TRIALS SUGGEST AS MANY AS 1 IN

50 TO 1 IN 100 PEDIATRIC PATIENTS DEVELOP A POTENTIALLY LIFE-THREATENING

RASH. IT BEARS EMPHASIS, ACCORDINGLY, THAT LAMICTAL IS NOT APPROVED FOR USE

IN PATIENTS BELOW THE AGE OF 16 (SEE INDICATIONS).

OTHER THAN AGE, THERE ARE AS YET NO FACTORS IDENTIFIED THAT ARE KNOWN TO

PREDICT THE RISK OF OCCURRENCE OR THE SEVERITY OF RASH ASSOCIATED WITH

LAMICTAL. THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY

ALSO BE INCREASED BY 1) COADMINISTRATION OF LAMICTAL WITH VALPROIC ACID

(VPA); 2) EXCEEDING THE RECOMMENDED INITIAL DOSE OF LAMICTAL; OR 3)

EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR LAMICTAL. HOWEVER, CASES HAVE

BEEN REPORTED IN ABSENCE OF THESE FACTORS.

NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMICTAL HAVE

OCCURRED WITHIN 2 TO 8 WEEKS OF TREATMENT INITIATION. HOWEVER, ISOLATED

CASES HAVE BEEN REPORTED AFTER PROLONGED TREATMENT (E.G., 6 MONTHS).

ACCORDINGLY, DURATION OF THERAPY CANNOT BE RELIED UPON AS A MEANS TO PREDICT

THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF A RASH.

ALTHOUGH BENIGN RASHES ALSO OCCUR WITH LAMICTAL, IT IS NOT POSSIBLE TO

PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE LIFE-THREATENING.

ACCORDINGLY, LAMICTAL SHOULD BE DISCONTINUED AT THE FIRST SIGN OF RASH,

UNLESS THE RASH IS CLEARLY NOT DRUG-RELATED. DISCONTINUATION OF TREATMENT

MAY NOT PREVENT A RASH FROM BECOMING LIFE-THREATENING OR PERMANENTLY

DISABLING OR DISFIGURING.

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The WARNINGS section has been revised to include the following information

regarding hypersensitivity reactions:

" Hypersensivity reactions: Hypersensitivity reactions, some fatal or

life-threatening, have also occurred. Some of these reactions have included

clinical features of multiorgan dysfunction such as hepatic abnormalities

and evidence of disseminated intravascular coagulation. It is important to

note that early manifestations of hypersensitivity (e.g., fever,

lymphadenopathy) may be present even though a rash is not evident. If such

signs or symptoms are present, the patient should be evaluated immediately.

LAMICTAL should be discontinued if an alternative etiology for the signs or

symptoms cannot be established.

Prior to initation of treatment with LAMICTAL, the patient should be

instructed that a rash or other signs or symptoms of hypersensitivity (e.g.,

fever, lymphadenopathy) may herald a serious medical event and that the

patient should report any such occurrence to a physician immediately. "

The medical community can further our understanding of LAMICTAL by reporting

adverse events to the Glaxo Wellcome Product Surveillance Department at

1-800-334-4153 or to the FDA MedWatch program by phone 1-800-FDA-1088, by

FAX at 1-800-FDA-0178, by modem 1-800-FDA-7737, or by mail:

MedWatch HF-2

FDA

5600 Fishers Lane

Rockville, MD 20857

Glaxo Wellcome is committed to helping you treat your epilepsy patients, and

encourages you to familiarize yourself with these changes to the package

insert so that the proper use of LAMICTAL may be facilitated through your

clinical care and treatment of patients. If you have any questions about the

new information in the package insert for LAMICTAL Tablets, please contact

the Drug Information Department at Glaxo Wellcome (1-800-334-0089)

Sincerely,

S. Kent, MD

Vice President and Chief Medical Officer

Glaxo Wellcome Inc.

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Glaxo Wellcome Inc.

Five Drive

PO Box 13398

Research Triangle Park

North Carolina 27709

Telephone: (919) 483-2100