FDA Safety Changes: Nasacort AQ, Reyataz, Zemuron
November 19, 2008 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to strengthen warnings and precautions related to the use of triamcinolone acetonide nasal spray in pediatric patients, warn of the risk for rash in patients receiving atazanavir sulfate therapy, and emphasize warnings related to the use of rocuronium bromide injection in certain settings.
Triamcinolone Acetonide Nasal Spray (Nasacort AQ) Warnings Strengthened
On September 19, the FDA approved safety labeling revisions for triamcinolone acetonide nasal spray (Nasacort AQ; sanofi-aventis US) to strengthen warnings and precautions related to its newly approved use in children aged 2 to 5 years.
Because of the rare risk for local Candida albicans infection of the mouth and pharynx, the FDA advises that children receiving triamcinolone therapy for several months or longer be periodically examined for evidence of Candida infection or other signs of adverse events on the nasal mucosa. Other rare local nasal effects may include epistaxis and nasal septal perforation.
Patient using immunosuppressants are more susceptible to infections vs healthy individuals, the FDA reminded clinicians, emphasizing that varicella zoster (chickenpox) and measles have been reported with increased severity and with some fatalities in susceptible individuals.
Particular care should be taken to avoid exposure in children and adults who have not had these diseases or have been properly immunized. Prophylaxis with varicella zoster immune globulin or pooled intramuscular immune globulin prophylaxis should be considered for patients exposed to disease.
Corticosteroids such as triamcinolone should be used with caution, if at all, in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex, the FDA warned, noting the potential for clinical worsening.
The FDA also warned of the risk for hypercorticism and adrenal suppression in patients receiving nasal steroids at higher-than-recommended doses and susceptible patients receiving usual doses. If these changes occur, triamcinolone should be slowly tapered and patients carefully observed for symptoms of withdrawal such as joint and/or muscular pain, lassitude, and depression. Rapid decreases in systemic corticosteroid dosage can cause severe exacerbation of symptoms in patients with asthma or other clinical conditions requiring long-term therapy.
Orally inhaled corticosteroids, such as triamcinolone, may also cause a reduction in pediatric growth velocity. Pediatric growth should be monitored routinely via methods such as stadiometry, and treatment should be titrated to the lowest effective dose.
Triamcinolone nasal spray is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 2 years and older.
Atazanavir Sulfate Capsules (Reyataz) Linked to Risk for Rash
On September 30, the FDA approved safety labeling revisions for atazanavir sulfate capsules (Reyataz; Bristol-Myers Squibb Co) to warn of the risk for rash associated with their use.
The incidence of rash (all grades, regardless of causality) across controlled clinical studies was approximately 20% in atazanavir-treated patients; median time to onset was 7.1 weeks and median duration, 1.3 weeks.
Most rashes consisted of mild-to-moderate maculopapular skin eruptions not requiring interruption of therapy, and the discontinuation rate for rash was less than 1% overall.
However, atazanavir should be discontinued in patients in whom a severe rash develops because cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions have also been reported.
Atazanavir is a protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Rocuronium Bromide Injection (Zemuron) May Cause Residual Paralysis
On August 28, the FDA approved safety labeling revisions for rocuronium bromide intravenous injection (Zemuron; Organon USA, Inc) to advise of warnings and precautions associated with its use.
Rocuronium should be administered in carefully adjusted doses by or under the supervision of experienced clinicians who are familiar with the drug’s actions and potential complications, the FDA advised. Clinicians administering this and other neuromuscular-blocking agents are advised to use a peripheral nerve stimulator to monitor drug effect, the need for additional doses, and the adequacy of spontaneous recovery or antagonism and to decrease the complications of overdosage if additional doses are administered.
To prevent complications resulting from residual paralysis, patients should only be extubated after they have sufficiently recovered from the neuromuscular block. Other factors that can affect residual paralysis should also be considered, such as drug interactions or patient condition; use of a reversal agent may be indicated in some cases.
The FDA also warned of reported myopathy after long-term administration of other nondepolarizing neuromuscular-blocking agents alone or in combination with corticosteroid therapy in patients receiving care in the intensive care unit. For patients receiving both types of drugs, use of the neuromuscular-blocking agent should be limited in duration and reserved for settings in which the specific benefits of the drug outweigh the risk.
Rocuronium injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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