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FDA Renews Concerns Regarding Botox and Death

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Hollywood, CAThe FDA is now renewing their concerns regarding the risk of death and other health issues that can arise as a result of using Botox. This renewed concern comes after the group Public Citizen, based out of Washington, asked the FDA to place the strongest possible black box warning on the Allergan company's very popular anti-aging product. It has been found that death has occurred in, not only FDA unapproved uses, but in FDA approved uses as well. This has resulted in an ongoing safety review regarding the overall risk of the drug.

Public Citizen has alleged that the recommended doses of the drug must be reevaluated and that something needs to be done about the relationship between the pharmaceutical companies and the doctors who prescribe the drugs. They also want to address any issues related to doctors who may be paid by the drug companies to prescribe their drug, and they want doctors who do have a relationship with the company to disclose that information to the patient. It is recommended for patients to ask the doctor if he or she have any financial ties with the pharmaceutical company such as a consultancy with them when being prescribed a particular drug.

The FDA is currently going over the safety data that has been collected from clinical studies conducted by the company that manufactures Botox and Botox cosmetics. Until this review is complete, they have instructed healthcare professionals to exercise various precautions more now than they ever have before.

In previous testimonies in lawsuits regarding conditions such as paralysis and even death as a result of using Botox, it has been stated under oath that the company did not know the risks of the drug in doses higher than 20 units. Doses higher than that poses the risk of the drug spreading to other areas of the body, which has an effect on neuromuscular transmission and can result in paralysis. It has also been admitted that the company's own studies revealed that Botox may have a connection with sinusitis, headaches, flu-like symptoms, pain, and respiratory problems.

In a book written by Alex Kuczynski, she reports that a the father of a woman, named Paulette Decourt, received Botox injections in the back of his neck during a clinical trial for Botox in 1995. After receiving these Botox injections, he experienced severe side effects that put him on a ventilator for two months before he passed away.

As far as how Allergan has handled the news of new reviews on their popular product and the recent drop in their shares, the company remains upbeat because the review the FDA is conducting has nothing to do with the cosmetic use of the product, but the medical uses for it.

The drug has been used to help manage juvenile cerebral palsy, which means it has been administered to these patients in large doses. According to Allergan, they are currently working with the FDA to make sure that all information is available regarding using reasonable judgment when it comes to administering the product. Botox is used in the treatment of juvenile cerebral palsy in around 60 countries and has been used by doctors in the United States for over ten years. However, it is not officially approved as a treatment for cerebral palsy in the United States.

Once approved, doctors can use the drug as they see fit. Botox was initially approved as a muscle spasm treatment, but was used to reduce wrinkles before it was actually approved as a cosmetic treatment. For patients who have received Botox injections, they should seek immediate medical attention in case of difficulty talking or swallowing, muscle weakness, and trouble breathing.

By Ginger Gillenwater


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