Potentially life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with OPANA ® ER in the postmarket setting. The most commonly described clinical features in these reports were swelling of the face, eyes, mouth, lips, tongue, hands, and/or throat; dyspnea; hives, pruritus, and/or rash; and nausea/vomiting. If anaphylaxis or other hypersensitivity occurs, stop administration of OPANA ® ER immediately, discontinue OPANA ® ER permanently, and do not rechallenge with any formulation of oxymorphone. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.
Persons who are using drugs that suppress the immune system (., corticosteroids) are more susceptible to infections than healthy individuals. Chickenpox and measles , for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin ( IG ) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chickenpox or measles develops, treatment with antiviral agents may be considered.
There are no adequate and well-controlled studies with QVAR in pregnant women. Animal studies were conducted with beclomethasone dipropionate in rats, mice, and rabbits. Systemic exposure data were not determined in the animal studies. In rats exposed to beclomethasone dipropionate by inhalation at doses greater than 180 times the maximum recommended adult human daily inhalation dose (MRHDID), doserelated gross injury to the fetal adrenal glands was observed. However, there was no evidence of external or skeletal malformations or embryolethality in rats at inhalation doses up to 440 times the MRHDID. Beclomethasone dipropionate was teratogenic (mice and rabbits) and embryolethal (rabbits) at subcutaneous doses equal to or greater than approximately times the MRHDID. Beclomethasone dipropionate treatment was embryolethal and caused decreased pup survival in mice at subcutaneous doses equal to or greater than times the MRHDID. Beclomethasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.