2002 Safety Alert - Accutane (isotretinoin) |
This is the retyped
text of a letter from Roche Laboratories. Contact the company for a copy
of any referenced enclosures.
|
Dear Accutane Prescriber,
Roche Laboratories would like to advise you of several recent changes to the Accutane Package Insert.
These changes involve the following sections:
1 ) Professional labeling WARNINGS: Psychiatric Disorders, and related sections in patient labeling
2) Pediatric Labeling, professional and patient
3) Boxed CONTRAINDICATIONS AND WARNINGS in professional labeling regarding pregnancy testing
WARNINGS: Psychiatric
Disorders
Aggressive and/or violent behaviors have been added to the list of events
that Accutane may cause, based on post-marketing safety reports. No mechanism
of action has been established for these events. This information has also been
added to the section entitled ADVERSE EVENTS: Psychiatric. Related
wording has been added to appropriate sections of the patient Medication Guide
and Informed Consent form.
Pediatric Labeling
Information specific to pediatric patients has been added to the Accutane Package
Insert based on the results of recent studies conducted in this patient population.
This information is found in the following sections, with related wording in
appropriate sections of the patient labeling:
CLINICAL PHARMACOLOGY: Special Patient Populations: Pediatric Patients
WARNINGS: Skeletal: Bone Mineral Density
PRECAUTIONS: Pediatric Use:
DOSAGE AND ADMINISTRATION: A statement has been added regarding the long-term use of Accutane as well as a statement advising that Accutane be given at the recommended doses for no longer than the recommended duration.
Boxed CONTRAINDICATIONS AND WARNINGS in Professional labeling: pregnancy testing
In the boxed CONTRAINDICATIONS AND WARNINGS, a new table has been added to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable.
Table 1. Use of Pregnancy Tests and
Accutane Qualification Stickers for Patients
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Patient Type |
Pregnancy
Test Required |
Qualification Date
|
Accutane
Qualification Sticker Necessary |
Dispense Within
7 Days of Qualification Date |
All Males |
No
|
Date Prescription
Written |
Yes
|
Yes
|
Females of Childbearing Potential |
Yes
|
Date of
Confirmatory Negative Pregnancy Test |
Yes
|
Yes
|
Females* Not of Childbearing Potential |
No
|
Date Prescription
Written |
Yes
|
Yes
|
*Females who have had a hysterectomy or who are postmenopausal are not considered to be of childbearing potential. |
Please refer to the enclosed complete updated product information for detailed information on the boxed contraindications and warnings, warnings, precautions, adverse reactions, and dosage and administration.
If you have any questions or would like to receive additional information on Accutane, please feel free to contact your Roche Laboratories' sales representative or call 1-800-526-6367.
Sincerely,
Ronald Gottschalk, MD
Medical Director, Dermatology
Roche Laboratories Inc.
Enclosures
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