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FDA 598 articles

Chinese researchers developing drug they say can cure Ebola

Ebola virus virion - CDC image

Scientists around the world are in a race to develop drugs to stop the worst Ebola outbreak in history. A handful of drug companies have developed experimental treatments with varying degrees of success. The latest promising development comes from Chinese researchers who say they have made a drug that effectively cures Ebola. Sihuan Pharmaceuticals Holdings partnered with support from the Academy of Military Medical Sciences (AMMS) has been developing JK-05 for the past five years. JK-05 is a micro-molecular chemical that selectively contains the RNA polymerase of the Ebola virus to inhibit virus replication. In September, the Chinese Food and Drug ... Read More

Medical device recall issued on IV delivery system due to life threatening defect

By LeoCarbajal (Own work) [CC-BY-SA-3.0 (http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

ICU Medical ConMed is issuing a medical device recall on the Stat2 Flow Controller, an IV administration system used to deliver or remove and control the amount of fluids from the body. The IV delivery system is being recalled because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow than what is set, which may cause serious health problems, including death. The recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will ... Read More

Potentially deadly ingredient found in dietary supplements

bodybuilding suppliments

About a dozen dietary supplements used for weight loss or body building contain a potentially deadly synthetic stimulant that has never been tested on humans, according to a Harvard Medical School study. The stimulant is known as DMBA, which stands for 1,3-dimethylbutylamine. It is similar to a compound known as DMAA, a stimulant that was marketed as a body building, athletic and weight loss enhancer. DMAA was banned by the Food and Drug Administration (FDA) because the FDA has received dozens of illnesses and death reports, including heart attacks, linked to DMAA-containing supplements. Thousands of dietary supplements are sold in the United States, and ... Read More

NIH, drug companies working to develop Ebola vaccine

Ebola virus virion - CDC image

Just months after the Ebola outbreak in Africa began spreading last spring, the National Institutes of Health (NIH) started human testing a vaccine to prevent the deadly Ebola virus, and the U.S. Department of Defense announced it is also working to develop a vaccine for the virus. Drugs to treat serious and life threatening illnesses can be granted expedited review by the Food and Drug Administration (FDA) to speed technologies and prevent possible spread of infectious disease. With Ebola becoming more of a global threat than ever before, the agency is allowing researchers with GlaxoSmithKline and the National Institute of ... Read More

Advocacy groups want stronger Chantix side effects warnings

smoking

Public watchdog groups are petitioning the federal government to put stronger warnings on the labels of the anti-smoking drug Chantix. The plea comes one week before the Food and Drug Administration (FDA) is scheduled to hear arguments from the drug’s maker that the black box warning for psychiatric problems should be removed. Chantix, made by Pfizer, contains the drug chemically known as varenicline. It works by binding to the places in the brain that are activated by nicotine when people smoke and prevents the “feel-good” brain chemicals that make people feel so addicted. The drug was approved by the FDA in ... Read More

Hospira recalls antibiotic used to treat infections in humans and animals

Recalls - Hospira-logo

Drug manufacturer Hospira Inc., has issued a nationwide recall of one lot of Vancomycin Hydrochloride for Injection, an antibiotic used in both humans and animals to treat or prevent bacterial infections including pneumonia and skin, bone, blood, and heart valve infections, because the drug may have been exposed to temperature variations during shipment that could have compromised its efficacy. The affected drugs were shipped to medical facilities and veterinary facilities. The recall includes Vancomycin Hydrochloride for injection (Sterile Powder) labeled with NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. Those who received shipments of the affected lots ... Read More

Ebola outbreak sparks race for new treatments

Ebola virus virion - CDC image

As Ebola concerns spike worldwide, drug companies are racing to develop treatments for the deadly virus. Last Friday, the Food and Drug Administration (FDA) granted emergency approval to the antiviral drug Brincidofovir to treat Thomas Duncan, the first person known to have been diagnosed with the deadly Ebola virus on U.S. soil. Duncan, who was in grave condition when treatment started, passed away Wednesday, but doctors say they still hold faith that Brincidofovir could save lives. It is currently being used on Ashoka Mukpo, the freelance cameraman who is being treated for Ebola in The Nebraska Medical Center’s Biocontainment Unit ... Read More

Women should not be treated with testosterone therapy, Endocrine Society advises

androgel-pump

Low testosterone is not a valid diagnosis in healthy women, and most women with low amounts of the hormone should not use testosterone-replacement drugs, the Endocrine Society said in a new guideline. “Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” guideline task force chair Dr. Margaret Wierman, of the University of Colorado, said in news release. Dr. Wierman said that in a review of past studies, women who had low testosterone levels did not exhibit any signs ... Read More

Reported transvaginal mesh injuries lead to creation of non-profit support group

2012-TVM-serious-complications

On October 20, 2008, the Food and Drug Administration (FDA) released a public health notification concerning the serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The FDA’s notification informed the public of the possible health risks associated with the treatment, recommended steps for physicians, and how to report an issue that has occurred because of surgical mesh. Despite the warnings released in 2008, the FDA reported in 2010 that around 300,000 women underwent surgeries to repair POP using the controversial product. Around 80 percent of 260,000 surgeries ... Read More

FDA is working to improve cybersecurity on network-connected medical devices

mobile medical app

Cybersecurity worries affect more than just retailers and businesses. Even the U.S. Food and Drug Administration (FDA) has begun addressing concerns regarding how to best protect patient health and information from hackers. Malware infections that have led to the compromise of millions of customers’ data has obviously put federal agencies like the FDA on its toes. If malware were to penetrate a medical device or network-connected FDA computer, the repercussions could be monstrous, including unauthorized password distribution, failure to receive periodic updates and unsecure access to private networks. Although the FDA has not reported any specific devices or systems that ... Read More