The Food and Drug Administration announced on Thursday to doctors around the country, including those purchasing and administering Botox in Syracuse and Central New York, that stronger product injury warnings must accompany Botox.
The FDA has instructed producers of Botox to ensure that boxes of the neurotoxin warn of the risk of side effects which may spread far beyond intended paralysis at an injection site, including difficulty breathing, trouble swallowing and blurred vision. Since 1997, there have been more than 650 adverse reactions to Botox, including 16 deaths.
A black box warning is the FDA’s strongest warning and is intended to signify a significant risk of danger. Like it sounds, a black box warning is contained within a black box. White text contrasts with the black box to ensure maximum visibility. Products that must have a black box warning and risk evaluation and mitigation strategy include: Botox, (botulinum toxin type A), Botox Cosmetic (botulinum toxin type A), Myobloc (botulinum toxin type B), and Dysport (abobutulinum toxin A).
The trial lawyers at Bottar Leone, PLLC, have decades of experience investigating, prosecuting and trying to verdict all types of product liability cases, including those arising out of dangerous pharmaceuticals. If you were injured due to a prescription dug or pharmaceutical, you and/or your family may be entitled to compensation for lifelong health care, special education, medical expenses, medical bills, loss of income, and pain and suffering.
To discuss your case or concerns with an experienced Central New York product liability attorney, contact Bottar Leone, PLLC now at (315) 422-3466, (800) 336-LAWS, or by e-mail at firstname.lastname@example.org.