MedWatch Safety Summaries

This is the retyped text of a letter from Ortho-McNeil Pharmaceutical. Contact the company for a copy of any referenced enclosures.

March 20, 1996

Dear Health Care Professional:

We have updated the prescribing information for ULTRAM^® (Tramadol Hydrochloride Tablets) to provide you with additional information regarding the potential for abuse, seizures, and anaphylactoid reactions. This information is based on experience obtained from the use of ULTRAM for the treatment of moderate to moderately severe pain in an estimated five million patients in the United States.

DRUG ABUSE:

One hundred fifteen spontaneous domestic reports of adverse events described as drug abuse, dependence, withdrawal, or intentional overdose have been received. This does not include cases of accidental overdose. Patients with a past or present history of addiction or dependence on opiods account for the majority of these reports. ULTRAM should not be used in such patients.

SEIZURES:

Eighty-three domestic reports of an adverse event described as seizures or convulsions have been received. Seizures have been reported after the first dose, at the recommended dosage range as well as at higher doses. In the majority of cases, a predisposing factor was identified. The risk of seizures is increased in patients taking concomitant medications that may reduce the seizure threshold (such as tricyclic anti-depressants and other tricyclic compounds, and selective serotonin reuptake inhibitors) and with certain medical conditions. The WARNINGS regarding seizure risk has been revised to include new information.

ANAPHYLACTOID REACTIONS:

Eleven domestic reports of anaphylactoid reactions have been received. Some of these reactions were reported to occur following the first dose and also in patients with a history of codeine allergy. Therefore, ULTRAM is contraindicated in patients hypersensitive to tramadol, any other component of this product, or opioids. A paragraph under the heading "Anaphylactoid Reactions" has been added to the WARNINGS.

DOSAGE AND ADMINISTRATION:

It is important that both you and your patients clearly understand and adhere to the dosage and administration instructions for ULTRAM. Recommended single and daily dosages should not be exceeded in an attempt to enhance pain relief. The recommended single and total daily dosage, one to two 50 mg tablets q4-6h, as needed, to a maximum of 400 mg/day, remain the same.

You should report adverse events to the ORTHO-McNEIL Pharmaceutical Medical Information Department at 1-800-542-5365 or to the FDA MEDWATCH program at 1-800-FDA-1088 or by mail, MEDWATCH, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland 20857.

Please review the enclosed REVISED PRESCRIBING INFORMATION in detail to ensure the appropriate use and maximum possible benefit from ULTRAM.

Sincerely

Thomas Gibson, MD
Executive Director

Ortho-McNeil Pharmaceutical
1000 Route 202
PO Box 300
Raritan, NJ 08869-0602

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