Nevirapine – FDA Summary of Drug alerts -1999

BOXED WARNING:

“SEVERE AND LIFE-THREATENING SKIN REACTIONS (STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS), INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE” Deleted –
Replaced with the following text –

“SEVERE, LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. THESE HAVE INCLUDED CASES OF STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE. (see WARNINGS)”

Nevirapine FDA Alert – 1999

FDA Listing for Viramune (Nevirapine)

SUMMARY OF SAFETY-RELATED DRUG LABELING CHANGES APPROVED BY FDA
OCTOBER 1999
(Posted: December 3, 1999)

Note: The following summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.

NB: Comparison made to 1999 Physicians’ Desk Reference (PDR), if drug’s labeling included in the PDR.

VIRAMUNE (nevirapine) Tablets & Oral Suspension
[October 25, 1999: Boehringer Ingelheim]
[Other labeling changes not appearing in 1999 PDR: Sep98]

[Other information regarding these changes: Letter]

BOXED WARNING:

“SEVERE AND LIFE-THREATENING SKIN REACTIONS (STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS), INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE” Deleted –

Replaced with the following text –

“SEVERE, LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. THESE HAVE INCLUDED CASES OF STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE. (see WARNINGS)”

CLINICAL PHARMACOLOGY:

Drug Interactions: Last paragraph, last sentence revised (new text in italics) –
“(See PRECAUTIONS, Drug Interactions, for recommendations regarding rifampin, rifabutin, oral contraceptives and methadone)”

WARNINGS:

First paragraph, first three sentences deleted –
Replaced with the following text –

“Severe, life threatening skin reactions, including fatal cases, have occurred in patients treated with Viramune. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions (including, but not limited to, severe rash or rash accompanied by fever, blisters, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise and/or significant hepatic abnormalities) must discontinue Viramune as son as possible. (See PRECAUTIONS, Information for Patients; ADVERSE REACTIONS)”

PRECAUTIONS:

Drug Interactions (new subsection):

“Methadone: Based on the known metabolism of methadone, nevirapine may decrease plasma concentrations of methadone by increasing its hepatic metabolism. Narcotic withdrawal syndrome has been reported in patients treated with Viramune and methadone concomitantly. Methadone-maintained patients beginning nevirapine therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.”

Information for Patients: New second sentence –

“Fatal skin reactions have been reported.”

Fifth sentence revised (new text in italics) –

“Any patient experiencing severe rash or hypersensitivity reactions (rash accompanied by constitutional [“symptoms” deleted] findings such as fever, blistering, oral lesions, conjunctivitis, [“swelling” deleted] facial edema , muscle or joint aches, [“or” deleted]general malaise, or significant hepatic abnormalities) should immediately discontinue medication and consult a physician.”

Last paragraph, new sixth and seventh sentences –

“Based on the known metabolism of methadone, nevirapine may decrease plasma concentrations of methadone by increasing its hepatic metabolism. Narcotic withdrawal syndrome has been reported in patients treated with Viramune and methadone concomitantly. Methadone-maintained patients beginning nevirapine therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.”

Antiretroviral Pregnancy Registry (new subsection):

“To monitor maternal-fetal outcomes of pregnant women exposed to Viramune, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling (800) 258-4263.”

ADVERSE REACTIONS:

Text and Tables extensively revised – Contact the company for a copy of the new labeling/package insert.

Leave a Reply

Your email address will not be published. Required fields are marked *