FDA has counted 11 cases of pulmonary hypertension in infants and newborns given Proglycem (diazoxide) for low blood sugar since the drug's 1973 approval. In every case it resolved or improved after the drug stopped. The agency is still investigating and urges close monitoring.
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Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
69% statin users experience adverse effects
Among 718 patients at two university hospital clinics in northeast Thailand, 76% taking statins reported one or more symptoms, and 69% had effects attributed to the drugs: 39.4% musculoskeletal and 18.7% liver-related.
Drug
Viagra boosts risk of melanoma
Among 25,848 men in the Health Professionals Follow-up Study, recent sildenafil users were 84 percent more likely to be diagnosed with melanoma than non-users, with no rise in squamous or basal cell carcinoma. The authors note the link does not establish cause.
Drug
Statins do not help healthy men with elevated cholesterol
Two Archives of Internal Medicine editors argue in JAMA that healthy men with high cholesterol should skip statins, citing reviews, one pooling 11 trials of 65,229 healthy but high-risk people, that found no reduction in mortality. They also note statins carry adverse effects.
Drug
Use of statins linked to type 2 diabetes mellitus in HIV patients
Among 5,692 patients with HIV, diabetes incidence ran 14% higher in those who took statins for a year, and risk climbed with more years of use. The researchers say patients should not avoid statins their doctors recommend for heart risk.
Drug
HBOT may help insulin sensitivity or type 2 diabetes mellitus in overweight men
Hyperbaric oxygen therapy raised insulin sensitivity 29 percent in 11 overweight men without diabetes and 57 percent in eight men with type 2 diabetes, with the gain lasting at least 30 minutes. Shifts in inflammatory cytokines may partly explain the effect.
Drug
Carefusion Provides Update on Voluntary Global Recall of Avea® Ventilator
CareFusion says FDA has designated its global AVEA ventilator recall Class I. A 5 psi pressure transducer can fail over time, triggering false alarms, opening the safety valve and stopping ventilation. Units made or serviced between July 2011 and March 2015 are affected; no injuries reported.
Drug
EPAM Life Sciences Awarded Grand Prize at Bio-IT World Best Practices Competition 2015
EPAM Systems and UCB won the Bio-IT World Best Practices Award for Research and Drug Discovery for AccelEpi, which detects epileptic seizures in rodents non-invasively using accelerometry. UCB says it allows testing against natural rather than induced seizures.
Drug
Baxter Recalls Select Lots of IV Solutions
Baxter is voluntarily recalling select lots of intravenous solutions to the hospital level after particulate matter from a solution transmission system pump turned up during routine maintenance. No adverse events or product complaints tied to the issue have been reported to the company.
Drug
End to Arsenic in Animal Drugs Long Overdue
Food & Water Watch's Wenonah Hauter welcomed Zoetis's plan to stop selling Nitarsone, the last arsenic-based drug used in poultry production, but called the step long overdue, noting the FDA took until 2014 to withdraw approvals for roxarsone and two other arsenicals.
Drug
Feraheme potentially triggers life-threatening allergic reactions - FDA
FDA added a Boxed Warning and a new contraindication to the anemia drug Feraheme after serious, sometimes fatal allergic reactions. Patients should seek emergency care for breathing problems, low blood pressure, dizziness, swelling, rash or itching.
Drug
Statins cut heart risk, but boost diabetes mellitus risk
Following HIV outpatients at eight clinic sites from 2002 to 2011, researchers found those who used statins had a moderately higher rate of new diabetes than those who did not, echoing earlier findings in other populations.
Drug
Can A Pill Really Make You Sexy?
The author argues that hormone replacement therapy was marketed to women as a way to stay youthful until it was tied to heart attacks and cancer, and that the same pitch now sells “Low T” to men while grief, ordinary life problems and children's behaviour get medicated.
Drug
Early use of antibiotics may boost asthma risk
A survey of 7,389 Seoul middle school students found antibiotic use in infancy, bronchiolitis in the first two years and parental asthma were each independent risk factors for childhood asthma; children with both antibiotics and bronchiolitis fared worst.
Drug
MAQUET Servo Humidifier 163 Recalled
Teleflex Medical issued two Class I recalls of the MAQUET Servo Humidifier 163 after cracks appeared in connectors and connector tubes. The cracks can let gases leak from a ventilator, risking serious injury or death, and customers must quarantine affected lots.
Drug
Bisphosphonates cut risk of type 2 diabetes mellitus
Using the UK Health Improvement Network database, researchers found patients exposed to the osteoporosis drugs were 50% less likely to be diagnosed with type 2 diabetes over 17 years, though risk rose during the first couple of years of exposure.
Drug
Tegafur-uracil (UFT) fights uterine cervical cancer
Of 309 uterine cervical cancer patients, the 162 given 600 mg a day of tegafur with uracil as maintenance therapy had significantly better overall survival than the 147 controls, especially in stage III and squamous cell disease. Nausea and vomiting affected 12.2 percent.
Drug
Penile Doppler ultrasound predicts risk of cardiovascular disease
A review from Hofstra North Shore LIJ School of Medicine argues penile Doppler ultrasound, which gauges cavernosal artery velocity, wall thickness and calcification, could help estimate cardiovascular risk in men with erectile dysfunction. An editor's note disputes calling ED a risk factor.
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