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Botox Gets New Label Warning

01 Oct Posted by admin in Breaking News | Comments
Botox Gets New Label Warning

Botox got a new label warning per the FDA. New Medication Guides for patients were also mandated.Botox injectionThe products Botox, Botox Cosmetic and Myobloc, have all revised their labels to include potential side effects, per the new FDA guidelines.

Dysport, another botulinum type A product, has already been using the new box warning since receiving FDA approval in April.

The dangerous side effects include breathing and swallowing difficulties that can occur if the botulinum toxin spreads from the injection area.

In fact, an analysis found that between 1997 and 2006, 180 patients developed difficulty after getting injections. Sixteen people died, including four children, at least one of whom was receiving Botox injections to treat spasms related to Cerebral Palsy. The speculation is that the patients were overdosed. Article continues below video player.

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The FDA announced that there have been no reports that the products have caused any problems when taken in the right doses. But the new drug labels also explain that since these three products require different doses, they are not interchangeable.

We spoke to Dr. Brian Kinney about the box label warnings and what they mean to patients.

Genuine U.S. FDA approved cosmetic injectables have a safe and predictable record of outcomes, and patients can minimize their risk of complications by seeking out a board certified plastic surgeon for their procedure.

 


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