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FDA’s Botox Warning Falls Short

Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen

Today, the Food and Drug Administration (FDA) reported that botulinum toxin (available as Botox and Myobloc) has been linked to adverse reactions, including respiratory failure and death. This announcement comes just two weeks after Public Citizen petitioned the FDA to immediately increase its warnings about the serious risks of using Botox and Myobloc. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. Our analysis of FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths.

The FDA could – and should – do much more than send out a press release about their concerns. Every doctor who is injecting botulinum toxin needs to know about the dangers of the toxin spreading to other parts of the body. The only way this is going to happen is by requiring the makers of the drug to send warning letters to all doctors who use Botox and Myobloc. Every patient needs to know about these risks, and the only way this is going to happen is if doctors are required to hand patients a written warning every time they receive an injection.

It’s not enough that the FDA publicly acknowledges the risks of using botulinum toxin; in fact, the agency did this much in a published article three years ago. The FDA must immediately force the drug makers to send out warning letters to doctors, similar to what drug regulatory agencies in Europe already require. The FDA also should label the products with a “black box” warning, the strongest warning the agency can make and require doctors to hand out medication guides to patients, warning them of the early symptoms of an adverse reaction.

The FDA needs to move quickly to educate physicians and patients. Nobody should be dying from injected botulinum toxin.

READ Public Citizen’s petition to the FDA.