FDA Investigating 5 Deaths Linked to Monster Energy Drink

FDA Investigating 5 Deaths Linked to Monster Energy Drink

The FDA has received reports of five people who died after consuming Monster Energy — Monster Energy Deathsa high-caffeine energy drink — in the past 3 years, the New York Times reports.

Other adverse events reported to the agency include one nonfatal MI, abdominal pain, vomiting, tremors, and abnormal heart rate. It is unclear whether patients who experienced adverse events also took alcohol or drugs.

In a statement, an FDA spokesperson said that it is the manufacturer’s responsibility to investigate adverse events associated with the beverage, according to the Times. She added that the FDA had not yet established a causal link between the energy drink and the deaths.

A 24-oz. can of Monster Energy contains 240 mg of caffeine, roughly equivalent to two cups of brewed coffee.

LINK(S):

New York Times story (Free)

Background: Physician’s First Watch coverage of AAP statement on sports and energy drinks (Free)

Published in Physician’s First Watch October 24, 2012

FDA approves new treatment for a type of late-stage prostate cancer

Aug 31, 2012
By: From staff reports
Drug Topics

FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer:

that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

Approved for prostate cancer patients previously treated with docetaxel, another cancer treatment, Xtandi was reviewed under FDA’s priority review program. Xtandi received FDA approval 3 months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012.

“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, MD, in a press release. Pazdur is director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”

Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 241,740 men will be diagnosed with prostate cancer and 28,170 will die from the disease in 2012.

The safety and effectiveness of Xtandi was evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received previous treatment with docetaxel. The study was designed to measure overall survival in men receiving Xtandi compared with men receiving a placebo. The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.

The most common side effects observed in study participants taking Xtandi were weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure.

Seizures occurred in approximately 1% of those receiving Xtandi. Patients in the study who had a seizure stopped Xtandi therapy. The clinical study excluded patients with a history of seizure, an underlying brain injury with loss of consciousness, a temporary decrease in blood to the brain within the past 12 months, a stroke, brain metastases, an abnormal connection of the arteries and veins in the brain, or patients taking medications that may lower the seizure threshold. The safety of Xtandi is unknown in patients with these conditions.

Pharmacy robot linked to bacterial contamination

Automated medication management systems:

are a common component of the pharmacy process in healthcare facilities. The integration of such devices has been shown to improve efficiency and patient safety. However, if automated devices are not used appropriately, their maintenance and education requirements can compromise patient safety.

Pharmacy personnel at Wake Forest Baptist Health in Winston-Salem, N.C., recently discovered bacterial contamination of the automated pharmacy robot used for intravenous medication preparation at the facility. As reported in Infection Control and Hospital Epidemiology, the staff discovered Bacillus cereus bacteria during routine quality assurance testing of the automated device, IntelliFill i.v. (Baxa). Bacillus, a spore-forming bacterium, is resistant to most commonly used disinfectants, including alcohol – a factor that has played a role in healthcare-associated infections.

“To our knowledge, this is the first published report of a pharmacy robot being contaminated with Bacillus with resultant contamination of intravenous drug product,” the article’s authors write. Katarzyna Gejdel, PharmD, BCPS, pharmacy manager at Bronx-Lebanon Hospital Center, Bronx, N.Y., concurred.

Getting to the root of the problem

A detailed investigation revealed that the washing station and its associated tubing were the potential source of contamination, as it was the only culture-positive site.

However, the authors report that they may never know how the organism was first introduced into the sterile environment of the robot. They have considered the possible risk of contamination from human hands during cleaning and setup. They advocate that current cleaning and maintenance requirements may need to be strengthened, since “the company’s recommendations to monitor the robot’s environment do not involve surface testing of the washing station, and has no defined schedule for exchanging the tubing or container.”

The report’s authors point out that the contamination was identified early, and confirm that, fortunately, no patient was harmed. But they caution that “the implications of contaminated intravenous product are potentially severe, most notably life-threatening bloodstream infections.”

To prevent other users of the robot from experiencing the same problem, the authors suggest that the manufacturer should consider “establishing a formal procedure for cleaning and maintaining the washing station, with detailed recommendations to change the drain tube, container, and possibly the washing station itself.” Furthermore, use of the robot in the pharmacy’s clean room could further decrease the risk of contamination.

While Gejdel acknowledges the authors’ concerns, she is not convinced that additional protocols are required at this time. “We have not experienced any such problem with our automated device or seen a report where patient safety has been potentially compromised, so I think it’s fair to say that the sterility assurance protocols currently provided by the manufacturer are sufficient,” she says.

Pivotal factors

Studies have shown that human-borne contamination is a principal threat to the sterility of compounded preparations and is a pivotal factor that needs to be controlled in an aseptic environment. Gejdel believes that, if used properly, the deployment of automation to remove the human element from the compounding of sterile preparations should significantly reduce the potential for microbial contamination. She advises that institutions that use automated pharmacy robots understand the limitations of technology and establish policies and procedures around competent use, quality assurance, and foreseeable complications.

“Ultimately, the pharmacy personnel are the most important determinants of quality. Following standard operating procedures and ensuring that all staff members who use the automated device receive initial and ongoing competency education are the cornerstone for promoting patient safety,” Gejdel says.

The American Society of Health-System Pharmacists’ guidelines on the safe use of automated dispensing devices (ADD) advocate that “the automated system should comply with applicable federal and state consumer protection laws and regulations, and state boards of pharmacy may have different requirements for the use of ADD in practice settings.” Gedjel supports this recommendation and believes that the state board of pharmacy’s involvement and legislation, where necessary, would be an added step in enhancing patient safety.

Monica Shah is a writer and hospital pharmacist in New Jersey.