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The U.S. Food and Drug Administration is implementing a number of steps for long-term safety monitoring of the permanent birth control device Essure

FDA Announces Safety Monitoring Measures for the Essure Device

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Measures include having women in the postmarket surveillance study followed for five years, not three
Patients taking fluoroquinolones may be at higher risk for ruptures or tears in the aorta

FDA: Fluoroquinolones Tied to Heart Vessel Ruptures, Tears

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Patients at risk include those with hypertension or certain genetic disorders and the elderly
Adverse events for immune checkpoint inhibitors used to treat non-small cell lung cancer may be more common in real-world settings than reported in the clinical trials that led to U.S. Food and Drug Administration approvals

Immunotherapy Side Effects May Be More Common Than Thought

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Higher rates of adverse events observed for immune checkpoint inhibitors in real-world settings
The onset of musculoskeletal adverse events during statin monotherapy is significantly faster with use of atorvastatin and rosuvastatin versus simvastatin

Onset of Musculoskeletal Adverse Events Varies Between Statins

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Significantly faster onset with atorvastatin, rosuvastatin versus simvastatin during monotherapy
Recommendations have been developed for pharmacovigilance in rheumatology

Pharmacovigilance Needed for Rheumatology Patients

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American College of Rheumatologists urges health care providers to monitor for adverse events
Emergency department visits for antibiotic adverse drug events (ADEs) in children account for 46.2 percent of emergency department visits for ADEs resulting from systemic medication

Many ED Visits for Antibiotic Adverse Drug Events in Children

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Antibiotic ADEs among children account for 46.2 percent of ED visits for ADEs tied to systemic meds
The rate of hospital-acquired conditions continued its decline from 2014 to 2016

Decline in Hospital-Acquired Conditions Continues

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Drop in adverse drug events, injuries from falls prevented 8,000 deaths, saved $2.9 billion
The U.S. Food and Drug Administration is warning patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant not to take azithromycin

FDA Warns Against Long-Term Azithromycin Use for Some

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Warning for blood cancer patients who have undergone donor stem cell transplant
Amid lawsuits and plummeting sales for its Essure birth control device

Bayer Stops U.S. Sale of Essure Birth Control Implant

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Problems with device include chronic pain and perforations of the uterus and fallopian tubes
A considerable number of randomized controlled trials of probiotics

Harms Reporting Limited in Trials of Prebiotics, Probiotics, Synbiotics

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No harms-related data reported for 28 percent of trials; safety results not reported for 37 percent