The consumer watchdog called on US authorities to require makers of Botox to include warnings about the risk of a deadly muscle disease.
The group Public Citizen filed a petition on Tuesday, urging the US Food and Drug Administration to force manufacturers to provide clearer warnings about how the treatment causes potential toxicity, even at recommended doses.
The fatal condition occurs when toxins used in Botox treatments spread beyond the intended treatment sites and cause muscle sagging.
The request comes after the group analyzed 5,400 reports of deaths, life-threatening events and other side effects related to Botox, and other cosmetic wrinkle treatments, that use these toxins.
The reports were submitted between January 1989 and March 2021 and were recorded in the FDA's Adverse Events Database.
The petition "requests that the black box warnings for both cosmetic and therapeutic Botox and related medications state that they are associated with botulism and related symptoms, even when used at recommended doses," the group said.
It also asked the FDA to remove a promotional paragraph stating that “there are no definitive reports of serious adverse events due to toxic effect” associated with Botox, when taken at the recommended dose for cosmetic use and for chronic health conditions such as excessive sweating and chronic migraines.
“Our petition is based on clear post-marketing evidence that refutes industry propaganda that claims Botox and related medications are 'always safe' and that there are no 'terminal' cases of toxicity with the recommended doses,” said Azza Abu Dagha, a health services researcher at Public Citizen.
Botulism is known as a rare infection that occurs when the bacteria "Clostridium botulinum", "Clostridium butyricum", or "Clostridium baratali" attacks the nerves of the body because it produces botulinum toxin.
According to the Centers for Disease Control and Prevention (CDC), this leads to difficulty breathing, muscle paralysis, double vision, drooping eyelids, slurred speech, and difficulty moving the eyes.
If left untreated, it can lead to permanent paralysis and death.
In 2019, according to the latest available data, the Centers for Disease Control and Prevention recorded 215 cases of Botulism in the United States.
The FDA said it will review the petition and respond directly to Public Citizen.
Foods that are beneficial and others that are harmful to the brain!
Nutritionist Daria Rusakova spoke about foods that affect human cognitive functions.
The doctor said in an interview with the Russian “Regnum” agency: “If a person feels concerned about the condition of his brain, he should focus on fish and dairy products, as well as various nuts and seeds.”
In addition, the doctor mentioned foods that negatively affect brain functions. She said that eating sausages and bacon poses a risk to brain health.
According to Rusakova, sausages are actually subjected to processing that causes a carcinogenic effect. Moreover, it contains excessive amounts of salt, cholesterol and various additives, which makes this product dangerous not only for the brain, but also for the human body as a whole.
The doctor warned that excessive consumption of foods containing cholesterol leads to disorders in the cardiovascular system, disrupting blood supply and brain functions. In addition, red meat can cause cancer of the digestive system, liver and other organs.
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