OriGen Biomedical recalled one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters, according to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website. The devices were recalled due to the risk of the clear extension tube separating from the hub in which it is inserted. Intervention may be needed to prevent permanent impairment or damage if this occurs. The recall affects lot N18549, which expires 09/2018. OriGen knows of at least one product failure, which is associated with a serious adverse event that led to a serious patient injury, the recall indicated. Continue reading
On Tuesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced that Beech-Nut Nutrition is recalling approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass.
The recalled baby food was produced on December 12, 2014. The following product is subject to recall:
- 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken”
An advocacy group for 9/11 responders and clean-up workers, Citizens for the Extension of the James Zadroga Act, has released a video, urging Congress to renew the James Zadroga 9/11 Health and Compensation Act. The Zadroga Act provides treatment and compensation for those who were injured or became ill after exposure to toxins in the aftermath of the 9/11 World Trade Center terrorist attacks.
The World Trade Center Health Program and the September 11th Victim Compensation Fund— key provisions of the act—will expire in October 2015 and October 2016, respectively, unless the Zadroga Act is renewed. U.S. Senator Kirsten Gillibrand is leading the effort for the Zadroga Act renewal. Gillibrand was a sponsor of the original legislation in 2010. Continue reading
The Food and Drug Administration (FDA) is facing criticism of its regulation of dietary supplements containing a dangerous stimulant. The stimulant is BMPEA, a chemical nearly identical to amphetamine. BPMEA is added to weight-loss and workout products to enhance their effect.
BPMEA has never been tested for safety and effectiveness in humans and is not a permissible ingredient in dietary supplements. The FDA was the first agency to suspect that BMPEA had been added to supplements that listed the little-known plant acacia rigidula among the ingredients. Experts say that plant listings like this are often an indication that the manufacturer is trying to disguise a chemical additive as a natural botanical extract, the New York Times reports. Continue reading
The U.S. Food and Drug Administration (FDA) is warning that Tri-Methyl Xtreme, a muscle-building supplement sold by Las Vegas company Extreme Products Group, has been linked to liver damage. According to Associated Press, the supplement was linked to three reported injuries in California, New Jersey and Utah. The FDA began investigating the product following these reports.
Tri-Methyl Xtreme claims to contain anabolic steroids, although it is sold as a dietary supplement. Dr. Charles Lee of the FDA drug center’s office of compliance said that anabolic steroids “may have a range of serious adverse effects on many organ systems, and the damage may be irreversible,” according to Wall Street Journal. The FDA warned that these chemicals can also negatively impact cholesterol levels, increase the risk of heart attack and stroke, cause masculinity in women and lead to testicle shrinkage. Continue reading
The Food and Drug Administration (FDA) is warning the beauty industry about some of the claims being made for some of its products. Five warnings letters have gone out to companies since November.
The most recent warning letter went out to StriVectin, whose wrinkle creams are sold by a wide range retailers, including Costco and Nordstrom, the Today show reports. The FDA objects to language in the ads that makes the products seem like drugs, not cosmetics. The language includes Continue reading
On Sunday, United States Senator Chuck Schumer called on the U.S. Food and Drug Administration (FDA) to ban dietary supplements, WHEC Rochester reports. Schumer says the ban should be implemented due to evidence showing that popular supplement products contain hidden stimulants. Many products contain an addictive, amphetamine-like chemical that is not listed on the label, Schumer said. The senator emphasized that the unknown ingredient can be dangerous for users, and that the FDA should issue a recall.
A recent study published in the journal Drug Testing and Analysis identified a number of supplements containing BMPEA, a substance similar to amphetamine. Supplements found to contain the substance include Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion. Researchers conducted the analysis after being unable to get answers from the FDA, who found BMPEA in nine out of 21 samples in a 2013 study but would not name the products. Continue reading
After conducting a preliminary review of data, the U.S. Food and Drug Administration (FDA) has issued a report indicating that AstraZeneca’s diabetes drug Onglyza may be linked with an increased rate of death. According to Reuters, an FDA advisory panel will meet on April 14 to discuss he risks of Onglyza and another similar drug.
Previous findings from the SAVOR trial, which was comprised of 16,000 patients taking Onglyza, showed that the drug was associated with an increased risk of hospitalization due to heart failure. The FDA reviewed the data and determined that the risk of heart failure is legitimate. Additionally, the FDA found that Onglyza may be linked to an increased risk of death from all causes. Even though the overall trial results did not point to an increased death risk, the agency’s review found that the drug may pose “a significantly increased risk of all-cause mortality,” upon further analysis. Continue reading
The U,S, Food and Drug Administration (FDA) has raised questions about the effectiveness of two generic medications used to treat attention deficit hyperactivity disorder (ADHD). The agency said in November that generic versions of Concerta, the long-acting version of Ritalin, may not be “therapeutically equivalent” to the brand name and may not have the same benefits,
“Two of these generics, so to speak, were not exactly providing the same rate and extent of absorption of medicine that Concerta had,” said Dr. Andrew Adesman of Steven and Alexandra Cohen Children’s Medical, according to CBS. Continue reading