Delayed diagnosis of opportunistic infections
The FDA notified healthcare practitioners that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis, and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor (TNF) alpha blockers. This has resulted in delays in appropriate treatment, sometimes causing death.
The FDA now requires manufacturers of the TNF-alpha blockers certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade) to highlight the information about the risk of invasive fungal infections in the boxed warning and warnings sections of the prescription labeling and the medication guide for patients. The agency also requires that the manufacturers of these medications educate prescribers about the risk.
For patients taking TNF-alpha blockers who present with signs and symptoms of possible systemic fungal infections, such as fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare providers should find out if patients live in or traveled to areas of endemic mycoses. Consultation with infection disease specialists should be sought and stopping treatment with the TNF-alpha blocker should be considered until the infection is diagnosed and adequately treated.
ED drug labeling to note transient global amnesia
Prescription labeling on all three marketed erectile dysfunction (ED) medications now list rare reports of transient global amnesia (TGA). TGA was added to the labeling of vardenafil (Levitra) earlier this year, with tadalafil (Cialis) and sildenafil citrate (Viagra) now featuring the same information on their product labeling. The change is not a warning or precaution, but is listed as part of the postmarketing section of the labeling.
According to Pfizer, there is no evidence of a causal relationship between the use of sildenafil citrate and TGA. The condition can occur for a variety of reasons and can be triggered by sex.
Particulate matter found in Ammonul injection
Ucyclyd Pharma, Inc., informed healthcare professionals about the detection of particulate matter in its injection product sodium phenylacetate and sodium benzoate (Ammonul injection), which may affect the safe use of Ammonul.
To ensure optimal patient care, healthcare providers should use a Millex Durapore GV 33-mm Sterile Syringe Filter (0.22 micrometer) during the admixture process when injecting Ammonul into the 10% Dextrose I.V. bag. The company cautions that the particulate matter may not be readily seen on visual inspection, so a filter must be used in all cases, regardless of whether the particulate matter is seen in the vial.
Testing confirmed the removal of the specific particulate when using the filter to admix Ammonul.
New safety information regarding Rituxan use
Genentech, Inc. and Biogen Idec, Inc. informed healthcare professionals of important new safety information regarding rituximab (Rituxan). The companies reported a case of progressive multifocal leukoencephalopathy (PML) leading to the death of a patient with rheumatoid arthritis (RA) who received Rituxan in a long-term safety extension clinical study. This is the first reported case of PML in a Rituxan-treated patient with RA.
The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of rituximab.
Healthcare professionals who are treating patients with rituximab should consider PML in any patient who presents with new-onset neurologic manifestations. Consultation with a neurologist, magnetic resonance imaging of the brain, and lumbar puncture should be considered as clinically indicated, according to the new labeling.