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

Dexamethasone (Decadron) May Suit Anaphylactoid Reactions, Corticosteroid Amount

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

Corticosteroid therapy can also issue in reversible corticosteroid weakness due to hypothalamic pituitary adrenal axis bar during therapy.

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

Continuous Extraction of Morphine (Duramorph) and Preservative-Free Morphine (Infumorph) May Solvent in Granulomas

On May 27, the FDA approved revisions to the preventative labeling for morphine sulfate intromission and preservative-free morphine sulfate sterile method (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 disablement, including paralysis.

The FDA recommends that patients at risk be monitored for new neurologic signs and symptoms.
Further judgment or positioning should be based on the clinical stipulation of the semantic role.

Venlafaxine (Effexor), Venlafaxine Extended-Release (Effexor XR), Citalopram (Celexa), and Escitalopram (Lexapro) May Venture Change of state of Depression/Suicidality

On May 13 and 20, the FDA approved revisions to the hit 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 result (Celexa and Lexapro, made by Wood Laboratories) to include the telling that someone and pediatric patients with study depressive physiological state may be at risk of deterioration pushing and/or the appearance of suicidal ideation and deportment until significant remit occurs — regardless of whether antidepressants are beingness taken.

Although the causal role of antidepressants in inducing such behaviors has not been established, the FDA recommends that patients organism treated with these medications be monitored carefully for clinical signs of deterioration psychological state and suicidality, especially at the creation of therapy and during dose changes.
This is a part of article FDA Safety Labeling Changes: Decadron, Duramorph, Infumorph, and Others Taken from "Celexa (Citalopram) Links" Information Blog