Botox Under FDA Scanner For Causing Respiratory Failure and Death

Three products, Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to adverse reactions, including respiratory failure and death, the U.S. Food and Drug Administration (FDA) warned

The most severe adverse reactions were seen in children being treated for spasticity in their limbs associated with cerebral palsydefine. At one end where FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, at the other end it is also not advising health care professionals to discontinue prescribing these products.

Additionally, FDA maintains the adverse reactions may be related to accidental overdosing of the drug and presently there is no reason to suspect that these adverse effects are related to any defect in the product.

As the potency determinations of the three Botulinum products are not identical, the appropriate dosages of the three products differ.

Currently, the FDA is making the following Botulinum product recommendations:

• The potency determinations expressed in 'Units' or 'U' are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the other.

• Be alert and aware of the systemic side effects following administration of botulinum toxins.

• These side effects can occur as early as one day after administration to as late as several weeks after treatment.

• Provide patients and caregivers with the information so that they are able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin.

• Ask patients to seek immediate medical attention if they notice any worsening or unexpected adverse reactions like, difficulty in swallowing or talking, trouble breathing.

Botulinum toxin, a neurotoxin protein produced by the bacterium Clostridium botulinum is one of the most toxic proteins and is commonly administered in cosmetic treatments to reduce the appearance of wrinkles.

Despite being one of the most toxic naturally occurring substances in the world, Botox is also used in the treatment of migraine headaches, cervical dystonia (a neuromuscular disorder involving the head and neck), anal fissures, TMJ pain disorders, etc.

Meanwhile, the agency is working on reviewing safety data from clinical studies submitted by the drugs' manufacturers and post-marketing adverse event reports related to Botulinum products.

On completion, the recommendations or regulatory actions, if any, will be made public, the authorities revealed.