FDA Safety Labeling Changes: Decadron, Duramorph, Infumorph, and Others

Yael Waknine

August 12, 2004

Aug. 11, 2004 — The U.S. Food and Drug Administration (FDA) approved in May revisions to drug safety labeling to advise healthcare professionals of the following changes: dexamethasone tablets may cause anaphylactoid reactions and corticosteroid insufficiency; continuous infusion of morphine sulfate can result in granulomas; antidepressants (venlafaxine hydrochloride, venlafaxine hydrochloride extended-release, citalopram hydrobromide, and escitalopram oxalate) may cause worsening of depression and suicidality; and amino acid injections contain aluminum that may be toxic.

Dexamethasone (Decadron) May Cause Anaphylactoid Reactions, Corticosteroid Insufficiency

On May 17, the FDA approved revisions to the safety labeling for dexamethasone tablets (Decadron, made by Merck), to include the warning that rare instances of anaphylactoid reactions have occurred in patients during corticosteroid therapy.

Corticosteroid therapy can also result in reversible corticosteroid insufficiency due to hypothalamic pituitary adrenal axis suppression during therapy.

Dexamethasone is used for its anti-inflammatory effect in disorders of many organ systems.

Continuous Infusion of Morphine (Duramorph) and Preservative-Free Morphine (Infumorph) May Result in Granulomas

On May 27, the FDA approved revisions to the safety labeling for morphine sulfate injection and preservative-free morphine sulfate sterile solution (Duramorph and Infumorph, both made by Baxter Healthcare Corp.), to include reports of inflammatory masses such as granulomas occurring in patients receiving continuous infusions of opioid analgesics by intrathecal indwelling catheter. Some of these have resulted in serious neurologic impairment, including paralysis.

The FDA recommends that patients at risk be monitored for new neurologic signs and symptoms. Further assessment or intervention should be based on the clinical condition of the patient.

Venlafaxine (Effexor), Venlafaxine Extended-Release (Effexor XR), Citalopram (Celexa), and Escitalopram (Lexapro) May Cause Worsening of Depression/Suicidality

On May 13 and 20, the FDA approved revisions to the safety labeling for venlafaxine hydrochloride tablets and venlafaxine hydrochloride extended-release capsules (Effexor and Effexor XR, made by Wyeth Pharmaceuticals Inc.) and for citalopram hydrobromide and escitalopram oxalate tablets and oral solution (Celexa and Lexapro, made by Forest Laboratories) to include the warning that adult and pediatric patients with major depressive disorder may be at risk of worsening depression and/or the emergence of suicidal ideation and behavior until significant remission occurs — regardless of whether antidepressants are being taken.

Although the causal role of antidepressants in inducing such behaviors has not been established, the FDA recommends that patients being treated with these medications be monitored carefully for clinical signs of worsening depression and suicidality, especially at the initiation of therapy and during dose changes.

Venlafaxine, venlafaxine extended-release, citalopram, and escitalopram are indicated in the treatment of major depressive disorder.

Amino Acid Injections (FreAmine, FreAmine HBC) Contain Aluminum That May Be Toxic

On May 27, the FDA approved revisions to the labeling for amino acid injections (8.5% and 10% FreAmine III, 6.9% FreAmine HBC), and amino acid injections with electrolytes (3% and 8.5% FreAmine III with electrolytes), all made by B. Braun, warning that the products contain aluminum, which may reach toxic levels with prolonged parenteral administration in patients having impaired kidney function.

Premature neonates are at particular risk due to kidney immaturity and requirements for large amounts of aluminum-containing calcium and phosphorus solutions.

The FDA recommends careful monitoring of central venous nutrition with frequent clinical and laboratory evaluations, emphasizing the need for knowledge of nutrition as well as clinical expertise in the recognition and treatment of complications.

Amino acid injections are designed to provide short-term parenteral nutrition in situations where enteral nutrition is not desirable or cannot be tolerated, as in postsurgical patients.

Reviewed by Gary D. Vogin, MD


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