Fungus, Bacteria Found in Compounded Steroids
Unopened vials of supposedly sterile methylprednisolone acetate, prepared by a Tennessee compounding pharmacy at the center of a federal investigation, contained both fungi and bacteria, the FDA said Friday.
FDA scientists cultured fungal and bacterial microbes from two vials of the injectable steroid from Main Street Family Pharmacy in Newbern, Tenn., each from different lots. The agency said its staff was working with the Centers for Disease Control and Prevention (CDC) to identify the specific species.
Steroids in 10-mL vials at 80-mg/mL concentrations were shipped to 17 states, the CDC reported earlier. They have been given by intramuscular injection. Patients in at least three states have developed skin and soft tissue abscesses after receiving the injections, the agencies said. No cases of fungal meningitis have been reported.
"At this point in FDA's investigation, the sterility of all sterile products produced by Main Street is of significant concern and the products should not be used," the FDA said. The pharmacy had issued a recall last month covering all products sold as sterile since November 2012.
Plug Pulled on Investigational Drugs
Disappointing clinical trial results have prompted AstraZeneca and Sanofi to halt development of several novel drugs.
Sanofi said it was cancelling its program on a once-promising cancer drug, iniparib. It cited failure to meet the primary endpoint of improved overall survival in a phase III study of patients with non-small cell lung cancer, as well as results of a phase II trial in ovarian cancer.
The company also said it was pulling the plug on otamixaban, an anticoagulant Factor Xa inhibitor, after it failed to outperform heparin (with or without eptifibatide) in a phase III trial in patients with non-ST elevation acute coronary syndrome.
For its part, AstraZeneca said it was stopping work on fostamatinib in rheumatoid arthritis (RA) in the wake of equivocal results from two phase III trials called OSKIRA-2 and OSKIRA-3. The firm said the drug was significantly superior to placebo in OSKIRA-2 at both of two dosing regimens evaluated. But in OSKIRA-3, fostamatinib was superior to placebo with only one regimen.
The first OSKIRA trial had also yielded less-than-stellar results, so AstraZeneca's decision to kill the program was not surprising. Fostamatinib is an orally active spleen tyrosine kinase (SYK) inhibitor and would have represented a new class of drugs for RA.
CDC Compiles Patient Notification Toolkit
Hospital officials and public health authorities who need to notify individuals potentially exposed to pathogens through lapses in infection control may now get standardized help from the CDC.
The agency has posted a "patient notification toolkit" on its website featuring instructions on developing notification documents and advice on communication strategies, resources, and best practices.
"This toolkit is intended to be used after a health department or healthcare facility decides to notify patients of their potential exposure to infectious organisms due to an unsafe practice or infection control breach," the CDC said on the website.
"Although the circumstances surrounding individual incidents may vary, the communication needs that follow are consistent and predictable," the agency stated.
Coronavirus Test Available to Public Health Labs
A CDC-developed molecular test for the MERS-CoV coronavirus, which has sickened dozens of patients in the Middle East and killed several, has been cleared for use by U.S. public health laboratories.
The FDA said it approved the real-time polymerase chain reaction (RT-PCR) test under an emergency declaration signed by Health and Human Services Secretary Kathleen Sebelius. The CDC will distribute the necessary primers and instructions to qualified laboratories for detecting the coronavirus in patients with clinical symptoms consistent with infection.
A similar PCR test for the H7N9 influenza virus was approved in April under a separate emergency declaration.
Cell Therapy Trial Placed on Clinical Hold
A clinical trial testing a placental cell-based treatment for intermittent claudication has been stopped by the FDA after one patient experienced a serious allergic reaction, its sponsor said.
Pluristem Therapeutics of Haifa, Israel, announced that the FDA had put a clinical hold on the trial until the firm supplies more information.
The company said 74 patients had received the treatment in the phase II trial, and that this was the first allergic reaction seen. "This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms," Pluristem said.
It said it was awaiting an official letter from the FDA "detailing a list of questions and requests for information."
Pluristem said the placenta-derived cells in the trial release "a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases."
Atomizer Recalled for Choking Hazard
Some lots of Nephron Pharmaceuticals' EZ Breathe Atomizer have been recalled because it contains a loose washer that patients could inhale, the FDA said.
The device is sold as a standalone product and is also included in Nephron's Asthmanefrin (racemic epinephrine) Starter Kit. Like other atomizers, it is intended to allow patients to take liquid medications by inhalation. Because of the risk of choking, the FDA designated the recall as Class I, the most serious type.
Nephron said the atomizer was produced by a contract manufacturer, Health & Life Co. Ltd. It did not indicate whether any patient injuries had resulted.
Lots affected by the recall were produced from May 2012 to October 2012, and shipped until April 2013. Specific serial numbers were posted on Nephron's website for Asthmanefrin.
