FDA recalls allergy drug over harmful bacteria that can lead to ‘life-threatening illness’
Hayfever: Use 'New anti-histamine' to combat allergy says Doctor
We use your sign-up to provide content in ways you’ve consented to and to improve our understanding of you. This may include adverts from us and 3rd parties based on our understanding. You can unsubscribe at any time. More info
The product, manufactured by Buzzago, has been distributed to wholesale distributors and retail stores in the US and is also available online on amazon.com. The medicine targets seasonal allergy symptoms and is used topically via nasal applications. According to the agency, testing revealed one lot of the products contained high levels of yeast and mould, in addition to bacillus cereus. It also announced the product, called Allergy Bee Gone for Kids Nasal Swab Remedy, has been recalled voluntarily by the manufacturer.
The FDA wrote on its website: “In immunocompromised patients, the use of the affected product would potentially result in severe or life-threatening adverse events, such as bacteraemia /sepsis, pneumonia, invasive fungal rhino-sinusitis, or disseminated fungal infection.”
It continued: “In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may results in infectious complications, for instance, bacteria or non-invasive final rhino-sinusitis, but in this population, the infections are expected to bless severely and more readily respond to treatment.”
The Agency added that the Buzzago has not yet received any complications related to adverse events related to the recalled lot.
The lot in question is numbered 2006491 and has a UPC code 860002022116, which is inscribed on the bottom of the product carton.
The food-borne pathogen Bacillus cereus is known to produce a toxin linked to two types of gastrointestinal illness.
The first, known as the emetic syndrome, triggers vomiting soon after ingestion of the contaminated food. The second illness is diarrhoeal syndrome.
Bacillus cereus, typically found in soil, can grow in raw plant foods like rice, potatoes, peans, beans and spices.
It can, however, also grow in any food source that isn’t stored properly, so it is important to handle cooked foods correctly after cooking.
When the pathogen enters the bloodstream it causes Bacteraemia, which can trigger the bodywide response known as sepsis.
The presence of bacteria in the blood usually causes no symptoms, unless it builds up in certain tissues and causes serious infection.
It can result from everyday activities including dental or medical procedures, or other infections like pneumonia.
When small quantities of the bacteria enter the bloodstream, the body is usually able to remove them without any medical intervention.
If the infection progresses to sepsis, however, symptoms are likely to emerge.
The MSD Manual explains: “Bacteraemia or another infection can trigger a serious bodywide response (sepsis), which typically includes fever, weakness, a rapid heart rate, and an increased number of white blood cells.
“The response also affects many internal organs, such as the kidneys, heart and lungs, which begin to fail.”
If the body goes into shock from sepsis, blood pressure is expected to fall dangerously low.
“As a result, internal organs typically receive too little blood, causing them to malfunction. Septic shock is life-threatening,” adds the health body.
According to the Sepsis Trust, 250,000 people are affected by life-threatening reactions in the UK every year.
In many of these cases, sepsis can lead to permanent and life-changing aftereffects, even if lives are spared.
Receiving immediate medical care is of the utmost importance, as antibiotics should ideally be administered within an hour of arriving at hospital, according to the NHS.
Source: Read Full Article
