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FDA 602 articles

Amy’s Kitchen recalls food products for Listeria risk

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Approximately 73,897 cases of various Amy’s Kitchen food products are now subject to a nationwide recall due to the discovery of Listeria monocytogenes by one of the Amy’s organic spinach suppliers. The ingestion and infection of Listeria monocytogenes in a healthy person will likely only cause short-term illness with symptoms including nausea, headache, high fever, abdominal pain and diarrhea. However, a severe Listeria infection affecting young children, elderly adults or those with a weakened immune system has the potential to be fatal. Pregnant women battling a Listeria infection may even experience a miscarriage or stillbirth – a devastating consequence for an ... Read More

Republicans propose massive changes to FDA oversight of drugs, medical devices

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House Republicans want to dramatically overhaul the Food and Drug Administration’s (FDA) regulation of prescription drugs and medical devices, tripling patent protection for brand-name drugs, stripping detailed safety information from promotional materials, cutting some of the red tape in clinical trials, and expediting approval of medical devices. The 400-page draft bill, known as the 21st Century Cures Initiative, comes after nine months of meetings from both parties on the House Energy and Commerce Committee. The guidance is designed to modernize FDA oversight of drugs and medical devices, and regulations. While both parties offered input, most of the priorities come from ... Read More

FDA warns of serious injuries in pediatric patients treated with bone graft substitutes

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Mounting reports of serious injuries in pediatric patients (younger than 18) who have received some types of bone graft substitutes have prompted the Food and Drug Administration (FDA) to issue a Safety Communication warning doctors that the safety and efficacy of these devices in pediatric patients has not been reviewed or approved and poses unique risks to patients younger than 18 years of age. The issue involves bone graft substitutes containing recombinant proteins or synthetic peptides, which have caused serious injuries in patients younger than 18 such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling. While these events ... Read More

Rader Farms Smoothie Blends recalled due to discovery of Listeria monocytogenes within key ingredient

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Several varieties of Rader Farms Smoothie Blends are now under recall by Inventure Foods, Inc. of Arizona. According to the announcement on the FDA’s website, organisms known as Listeria monocytogenes are believed to have contaminated the spinach and/or kale ingredients in the recalled smoothie blends; however, the organisms were not discovered in the blends themselves. Listeria monocytogenes is responsible for sickening individuals with weakened immune systems, such as young children and elderly people. The listeria infection, which may be fatal, carries symptoms including high fever, nausea, stiffness, severe headache, diarrhea and abdominal pain. Pregnant women could potentially suffer miscarriages or stillbirths ... Read More

Chinese researchers developing drug they say can cure Ebola

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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

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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

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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

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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

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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