Recalls, warnings and label changes
A warning against co-administration of boceprevir (Victrelis) with certain ritonavir-boosted HIV protease inhibitors because of the possibility of reduced effectiveness. Ritonavir-boosted HIV protease inhibitors include atazanavir (Reyataz), darunavir (Prezista) and lopinavir/ritonavir (Kaletra). Clinicians who started patients on boceprevir while the patient was taking one of the ritonavir-boosted protease inhibitors should closely monitor for treatment response and for potential HCV or HIV virologic rebound.
A recall of one lot of epinephrine injection, USP, 1:1000, 1 mL ampules due to discoloration and small visible particles.
A recall of Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT immunoassays because they may provide a falsely low result and incorrect results may cause serious adverse health consequences, including death.
A warning that aliskiren-containing medications are contraindicated with angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or renal impairment because of the risk of renal impairment, hypotension and hyperkalemia. Brand names of aliskiren-containing medications include Amturnide, Tekturna, Tekturna HCT, Tekamlo and Valturna (which will no longer be marketed after July 2012).
A recall of one lot of morphine sulfate injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject due to a customer report of two syringes containing more than the 1 mL labeled fill volume.
A warning on Other-Sonic generic ultrasound transmission gel because of bacterial contamination with Pseudomonas aeruginosa and Klebsiella oxytoca. Risks of exposure include inflammatory dermatitis and possibly more serious infections. Patients who have been exposed to the contaminated lots should be identified and their outcomes reviewed.
A warning on lenalidomide (Revlimid) about increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma. Specifically, clinical trials showed increased risk of acute myelogenous leukemia, myelodysplastic syndromes and Hodgkin lymphoma.
A warning and recall on Brilliant Blue G and triamcinolone-containing products from Franck's Pharmacy, due to additional reports of fungal endophthalmitis in patients who were given these products during eye surgery.
Avanafil (Stendra), a new phosphodiesterase type 5 (PDE5) inhibitor to treat erectile dysfunction. The drug is a pill taken on an as-needed basis 30 minutes before sexual activity. Doctors should prescribe the lowest dose that provides benefit, and the drug should not be used by men who take nitrates. Approval was based on three double-blind, placebo-controlled clinical studies of 1,267 patients in which patients taking the drug experienced statistically significant improvement in erectile function, vaginal penetration and successful intercourse.
A new indication for everolimus (Afinitor), to treat renal angiomyolipomas not requiring immediate surgery in patients with tuberous sclerosis complex. The FDA has previously approved the drug, under the orphan drug program, to treat several other specific conditions. Approval for the new indication was based on a double-blind, placebo-controlled clinical trial of 118 patients in which 42% showed a substantial reduction in tumor size lasting, on average, more than five months.
A new indication for pazopanib (Votrient) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. The drug was first approved in October 2009 for the treatment of advanced kidney cancer. It carries a boxed warning about the potential risk of hepatotoxicity, which can be fatal. Approval of this orphan drug indication was based on a study of 369 patients in which median progression-free survival was 4.6 months compared with 1.6 months on placebo.
Taliglucerase alfa (Elelyso), long-term enzyme replacement therapy to treat a form of Gaucher disease. The drug is an every-other-week injection for patients with a confirmed diagnosis of Type 1 (non-neuropathic) Gaucher disease. Due to the small number of affected patients, the efficacy was evaluated in trials with a total of 56 patients.
A new indication for levofloxacin (Levaquin) to treat plague and to reduce the risk for acquiring it after exposure. Under the Animal Efficacy Rule for rare diseases, the drug's approval was based on a laboratory trial of African green monkeys that were infected with the plague bacterium Yersinia pestis. Survival was 94% in the levofloxacin group and 0% in the placebo group. Plague is extremely rare in most parts of the world, with 1,000 to 2,000 cases worldwide each year, according to the FDA.
The FDA recently issued a reminder about of the importance of appropriate storage, use, application, and disposal of fentanyl patches (including Duragesic and generic products). The agency recently evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches, of which ten resulted in death and 12 in hospitalization. Young children are at particular risk of accidental exposure to fentanyl patches, whether they find one on their own or are held by someone wearing a partially detached patch which can then transfer to the child.