FDA Safety Labeling Changes: CombiPatch, Efudex, Percodan, and Axert

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FDA Safety Labeling Changes: CombiPatch, Efudex, Percodan, and AxertFor those

who use the following medications or know someone who does, please take note:

Ann-Marie

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September 14, 2004

FDA Safety Labeling Changes: CombiPatch, Efudex, Percodan, and Axert

Yael Waknine

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Sept. 8, 2004 - The U.S. Food and Drug Administration (FDA) approved

in June revisions to safety labeling to advise healthcare professionals of the

following changes: estradiol/norethindrone patches are contraindicated in

patients with cardiovascular disorders and venous thromboembolism, fluorouracil

topical cream is contraindicated in patients with dihydropyrimidine

dehydrogenase enzyme deficiency, oxycodone/aspirin tablets have multiple

contraindications, and almotriptan malate may be associated with serious cardiac

adverse events and fatalities.

Estradiol/Norethindrone Acetate Transdermal System (CombiPatch)

Contraindicated in Cardiovascular Disorders and Venous Thromboembolism

On June 18, the FDA approved revisions to the safety labeling for

the estradiol/norethindrone acetate transdermal system (CombiPatch, made by

Novartis) to reflect additional contraindications for use.

Combination estrogen/progestins are contraindicated in women with

known, suspected, or a history of breast cancer and in those with active deep

vein thrombosis, pulmonary embolism, or a history of these conditions. Women who

have active arterial thromboembolic disease or have had a thromboembolic event

such as stroke or myocardial infarction within the past year should not use the

patch.

The estradiol/norethindrone patch is indicated for the treatment of

moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated

with menopause. It is also indicated for the treatment of hypoestrogenism due to

hypogonadism, castration, or primary ovarian failure.

Fluorouracil Topical Cream (Efudex) Contraindicated in DPD Enzyme

Deficiency

On June 24, the FDA approved revisions to the safety labeling for

fluorouracil topical cream (Efudex, made by Valeant Pharmaceuticals

International) to reflect its contraindication in patients with

dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

Intravenous administration of fluorouracil in patients with DPD

enzyme deficiency has resulted in rare reports of life-threatening toxicities

including stomatitis, diarrhea, neutropenia, and neurotoxicity. One such case

has been reported with topical use of fluorouracil cream 5%. It is unknown

whether patients with profound DPD enzyme deficiency can develop systemic

toxicity with lower concentrations of topically applied fluorouracil.

The FDA advises discontinuation of fluorouracil topical cream

therapy in patients who develop symptoms of DPD enzyme deficiency.

Fluorouracil topical cream is indicated for the treatment of

multiple actinic or solar keratoses and superficial basal cell carcinomas when

conventional methods are impractical.

Oxycodone/Aspirin Tablets (Percodan, Percodan-Demi) Contraindicated

in NSAID Allergies, More

On June 6, the FDA approved revisions to the safety labeling for

oxycodone and aspirin tablets (Percodan and Percodan-Demi, made by Endo

Pharmaceuticals) to reflect additional contraindications for use.

The oxycodone/aspirin combination is contraindicated in children or

teenagers with viral infection with or without fever due to the risk of Reye's

syndrome associated with use of aspirin in certain viral illnesses. Its use is

also contraindicated in patients with allergic reactions to nonsteroidal

anti-inflammatory drugs and in those with the syndrome of asthma, rhinitis, and

nasal polyps because it can cause severe urticaria, angioedema, and

bronchospasm.

Oxycodone/aspirin tablets are also contraindicated in patients with

known oxycodone sensitivity. Oxycodone should not be used in patients with

significant respiratory depression in unmonitored settings or in the absence of

resuscitative equipment. It is also contraindicated in patients with acute or

severe bronchial asthma or hypercapnia and in the setting of suspected or known

paralytic ileus.

Oxycodone/aspirin tablets are indicated for the treatment of

moderate to moderately severe pain.

Almotriptan (Axert) Linked With Serious Adverse Cardiac Events,

Fatalities

On June 1, the FDA approved revisions to the safety labeling for

almotriptan malate tablets (Axert, made by Janssen Ortho), to include reports of

serious adverse cardiac events, including acute myocardial infarction, that have

occurred within a few hours after almotriptan administration.

Almotriptan is known to cause coronary vasospasm. The FDA has

received at least one report of vasospasm in a patient with no cardiac history

and having a documented absence of coronary disease.

Due to the close proximity of these events to use of almotriptan, a

causal relationship cannot be excluded. According to the FDA, the uncontrolled

nature of postmarketing surveillance makes it difficult to ascertain the

proportion of reported cases caused by almotriptan and attribute causation to

almotriptan use in individual cases.

Almotriptan is indicated for the treatment of acute migraine with or

without aura in adults.

Reviewed by D. Vogin, MD