Patient Safety in the News December 2014

Recent changes in drug labels: The following drugs had modifications to the contraindications, warnings or precautions section of their labels: Adcetris (brentuximab vedotin) for Injection; Arava (leflunomide) Tablets; AVELOX (moxifloxacin hydrochloride) Tablets and IV; Bosulif (bosutinib) Tablets; Cardizem (diltiazem hydrochloride) Tablets; Cubicin (daptomycin for injection) Intravenous; Cymbalta (duloxetine) Delayed-release Capsules; Foscavir (foscarnet sodium) Injection; Lopid (gemfibrozil) Tablets; Mycobutin (rifabutin) Capsules; Mytelase (ambenonium chloride) Tablets; Sensipar (cinacalcet hydrochloride) Tablets; Sovaldi (sofosbuvir) Tablet; Sylatron (peginterferon alfa-2b); Taxotere (docetaxel) Injection Concentrate; Unasyn (ampicillin sodium/sulbactam sodium) Injection; Votrient (pazopanib hydrocholoride) Tablets and Zelboraf (vemurafenib) Tablet. Click here for more information from the FDA.

Robert Pear, for the New York Times, reported on a study which revealed that half of the physicians listed as serving Medicaid patients were unavailable either because they were not actually taking Medicaid patients or because the information about their medical practice was outdated.

Robert Preidt, for Health Day, discussed a study in the Annals of Epidemiology that indicated that despite lower smoking rates, cigarettes are still responsible for 3 out of 10 cancer deaths in the United States.   

Marie Ellis, with Medical News Today, reported on an article in JAMA Pediatrics which found that children diagnosed with autism spectrum disorder were twice as likely to be born with mothers with preeclampsia during pregnancy.

The FDA issued a drug Safety Announcement relative to the drug Ziprasidone (Geodon), which has been found to cause DRESS syndrome. DRESS syndrome begins as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.

Jack Jacob, MD, et als. Published an article in Pediatrics which concluded that 31% of infant deaths in a neonatal intensive care unit were potentially preventable. The following factors were said to contribute to unnecessary morbidity and mortality: delivery at a center without appropriate level of support (10%), limited or no prenatal care (8.9%), mothers who smoked tobacco during pregnancy (16%), maternal use of nonprescription drugs (7.3%) and alcohol abuse (4%). 

Steven Reinberg, for Health Day,  reported on an article in JAMA that concluded that restrictions on the hours of hospital interns and residents were not leading to safer care.

Tamara Rosin, for Becker’s Infection Control and Clinical Quality, discussed an article published in JAMA Internal Medicine that indicated that 85% of doctors surveyed believed that prescription drug abuse is a big community problem where they practice.

The FDA announced that Alere Inc. initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not monitored with their INR systems because in certain circumstances the INR measurements are significantly are inaccurate.

Jayne O'Donnell, with USA TODAY, discussed the annual America’s Health Rankings published by United Health Foundation, the American Public Health Association and Partnership for Prevention. The country’s obesity rate increased from 27.6% to 29.4% in adults. Obesity and diabetes have more than doubled over the last 25 years.

Robert Preidt, for Health Day, discussed an article in the Journal of Health and Social Behavior which concluded that if people were advised that they had a genetic risk for disease they would take action to learn more about the disease, take medication or undergo surgery to avoid the disease, or get more involved in community and political events related to the disease.

The FDA announced new rules that will require additional information on drug labeling related to the potential impact of drugs on lactation and pregnancy. The rules will go into effect in June 2015.

Amy Norton, for Health Day, reported on a study appearing in the journal Heart that concluded that the benefits of taking low dose aspirin to lower the risk of heart attack, stroke and colon cancer for women under the age of 65 was outweighed by the increased risk of gastrointestinal bleeding.

Sheryl Wood, for Daily Rx, discussed an article appearing in Pediatrics which concluded that children born by cesarean section had an increased risk of developing immune diseases, including asthma, juvenile arthritis, inflammatory bowel disease, immune deficiencies, connective tissue disorders and leukemia.

Dennis Thompson, for Health Day, discussed the fact that the flu season has the potential to be worse this year because a strain of the flu called H3N2 appears to be circulating more widely this year. H3N2 is a strain that has resulted in more hospitalizations and deaths than in past years and it also appears to be mutating and drifting away from the virus strain in this year's vaccination. In addition to vaccination, the CDC is recommending that doctors use antiviral medications (Tamiflu and Relenza) at the first signs of flu sickness. 

Sheila Yu, Dr. Daily Rx, discussed a study published in JAMA Internal Medicine that concluded that individuals starting antiretroviral therapy within a year of being infected with HIV have a better chance of maintaining health becuase hey have a greater chance of normal white blood cell (T-cell) counts.

Tara Haelle, for Health Day, discussed a study in Pediatrics that concluded that the longer babies are breastfed, the less likely it is that they will become obese children.

Noam Levey, for the Los Angeles Times, reported that health spending increased at the lowest rate ever recorded in 2013. The slowdown in health care spending was driven by the sluggish economy and the Affordable Care Act. 

Tara Haelle, for Health Day, reported on a study published in BMJ that concluded that maternal obesity raises the risk of infant mortality.

Alan Mozes, for HealthDay, discussed a study published in Clinical Cancer Research that indicated that an experimental vaccine designed to stop the progression of breast cancer appeared to be safe and was able to generate an immune response in patients who were vaccinated.

Andrew M. Seaman, for Reuters, discussed an article in the Annals of Internal Medicine that demonstrated that people with diabetes suffered from greater levels of cognitive decline later in life than those without the disease.          

An article published in the journal Pediatrics concluded that physicians should disclose errors that harmed pediatric patients.

Linda Searing, for the Washington Post, reported on a study published in the online version of Neurology that indicated that individuals who worked in complex jobs had increased cognition as they aged.

Dennis Thompson, for Health Day, discussed an article published in the American Journal of Cardiology which concluded that patients who received adrenaline injections to restart their heart were more likely to suffer brain damage than patients who did not receive the drug.

Eileen Oldfield, for Pharmacy Times, reported on a survey published in Preventing Chronic Disease that concluded that there was a gap in testing patients with hypertension for diabetes, given that these two conditions are often comorbidities.