December 3, 2014. The FDA’s regulation of blood establishment computer software (BECS) and BECS accessories has enhanced the safety of blood transfusion. However, it should be noted that the only national statistics we have to measure safety are based on a passive reporting system.
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NCHR Position on the Safety of Essure Permanent Birth Control
November 6, 2014. The NBC investigation of Essure has raised very important questions regarding the safety of the Essure permanent birth control device.
Read More »NCHR Testimony at FDA Joint Public Advisory Committee Meeting on Chantix
October 16, 2014. NCHR strongly urges the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, the FDA should delete the misleading meta-analyses info from the Chantix label.
Read More »Chantix Citizen Petition
October 8, 2014. Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928.
Read More »NCHR Testimony at FDA Advisory Panel on the WATCHMAN™ Left Atrial Appendage Closure Device
October 8, 2014. In summary, patients implanted with the device are at increased risk for ischemic stroke. Methodological problems make it difficult to assess if the device reduces hemorrhagic strokes. The decrease in major bleeding events after 6 months is negated by the increased major bleeding events due to surgery. The device is inferior to warfarin for 2 of the 3 primary endpoints identified by the sponsor and the FDA as signifying success.
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