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Weekly News Round Up - January 18, 2012

Orphan Drug Approval: Voraxaze To Treat Methotrexate Toxicity

Voraxaze (glucarpidase) is FDA-approved to treat methotrexate toxicity due to kidney failure Read More...

Methotrexate, used as a chemotherapeutic agent, is normally eliminated from the body by the kidneys. However, high doses and prolonged exposure of the drug may lead to kidney impairment. The U.S. Food and Drug Administration has approved Voraxaze (glucarpidase), an intravenous carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function. A clinical study evaluated Voraxaze in 22 patients, all of whom received the active drug. Ten of the 22 patients achieved the required reduced methotrexate levels within 15 minutes and maintained this level for eight days. Overall, Voraxaze eliminated 95 percent of methotrexate in all patients.

Adcetris (brentuximab vedotin): New Boxed Warning and Contraindication

Added cases of progressive multifocal leukoencephalopathy (PML) and bleomycin lung toxicity result in Adcetris label change Read More...

Adcetris (brentuximab vedotin) is used for the treatment of Hodgkin lymphoma and rare systemic anaplastic large cell lymphoma. Progressive multifocal leukoencephalopathy (PML) has been reported in conjunction with the use of Adcetris, prompting a new boxed warning. PML is a rare but serious brain infection that may result in death. Symptoms of PML can include mood changes, confusion, memory loss, vision, speech or walking changes and weakness on one side of the body. Patients experiencing these symptoms should notify their healthcare provider immediately. In addition, the combined use of Adcetris with bleomycin is now contraindicated due to an increased risk for lung toxicity.

FDA Drug Safety Update: CardioGen-82 PET Scan Radiation Exposure

Excessive radiation exposure led to recall of CardioGen-82 in July 2011; improper usage at clinical sites may be cause Read More...

CardioGen-82 contains a generator that that is used to produce rubidium (Rb)-82 chloride injection to clinically evaluate the heart during positron emission tomography (PET) scanning. Preliminary information from the U.S. Food and Drug Administration’s (FDA) ongoing investigation suggests that improper usage of CardioGen-82 may have been the cause for excessive radiation exposure in some patients. Unwanted radiation exposure can occur when the injected solution contains excessive strontium-82 and strontium-85, known as “strontium breakthrough.” The FDA is working with the manufacturer to characterize the problems, revise labeling and implement a plan to return CardioGen-82 to the market.

Abuse of Designer Drug Known as “Bath Salts” Leads to Amputation

“Bath salt” intramuscular injection results in rapidly progressive necrotizing fasciitis Read More...

“Bath salts” are a dangerous designer drug of abuse and central nervous system stimulant. On September 7, 2011 the US Drug Enforcement Agency announced emergency scheduling to control MDPV, mephedrone and methylone, all chemicals found in "bath salts". As of October 8, 2011, it is a federal offense to have or sell "bath salts". A recent report summarizes a case of necrotizing fasciitis that occurred in a 34-year old woman who developed forearm pain and redness after an intramuscular injection of ”bath salts” at a party. Her disease progressed rapidly, resulting in amputation of her arm, shoulder, and collarbone. Surgeons had to perform a radical mastectomy, as well.

Recall of Vecuronium Bromide and Polymyxin B Injections

Bedford Laboratories has issued guidance on recalls of vecuronium bromide and polymyxin B injections due to visible glass particles Read More...

Polymyxin B is used for treatment of acute infections caused by Pseudomonas aeruginosa, and vecuronium bromide is a neuromuscular blocker used as an adjunct during general anesthesia to facilitate intubation and ventilation. Glass particulate matter was found in three lots of these medications manufactured by Bedford Laboratories, and a voluntary nationwide recall was issued on August 2, 2011. All health care providers or facilities should not use the recalled lots and should quarantine the product for return to the manufacturer. Particulate matter in injectable preparations can cause serious effects, including vein occlusion, local tissue infarction and death. To date, no adverse events have been reported for the recalled lots.