May 5, 2009: Botulinum Toxin Products To Carry Black Box Warning
May 5th, 2009
Serious Adverse Events Are Linked To Botulinum Toxin Products:
The FDA will require labeling for the botulinum toxin products BOTOX®, Myobloc®, Dysport® to include a “Black Box Warning,” alerting doctors and patients of the serious and life-threatening side effects that these products can trigger. A Black Box Warning is the strongest warning that the FDA can require a prescription drug to include in its labeling.
Botulinum Toxin Products Labeling Change:
BOTOX®, Myobloc®, and Dysport® all contain the same toxin that causes botulism. The FDA has mandated the Black Box Warning following reports that the effects of the botulinum toxin may spread from the injection site to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
In its News Release, the FDA stated that these side effects have been reported most frequently in children with cerebral palsy and being treated with the products for muscle spasticity, an unapproved use of the drugs. Side effects have also been reported in adults treated both for approved and unapproved uses.
The updated labeling changes will also include safety information alerting doctors that BOTOX®, Myobloc®, and Dysport® are not interchangeable. The lack of interchangeability presents the potential for serious safety risks such as overdosing of patients.
What You Can Do To Protect Your Legal Rights:
Since 1984, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by dangerous and defective drug products. The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products. We are ready to help you. If you believe that you or a family member was injured as a result of BOTOX®, Myobloc®, Dysport® therapy please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274.
To learn more about the Law Practice of Eric H. Weinberg, please see Drug Lawsuit Lawyer and Food Poisoning Lawyer.
Entry Filed under: Recent Outbreaks and Food Recalls
243 Comments
1. scott&hellip | December 23rd, 2013 at 1:15 am
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156. Morris&hellip | December 9th, 2014 at 11:52 am
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ñïàñèáî!…
157. Steve&hellip | December 10th, 2014 at 5:56 pm
surmounted@superstitions.alerts” rel=”nofollow”>.…
good info!…
158. Leo&hellip | December 11th, 2014 at 2:13 am
impossibility@sadder.fer” rel=”nofollow”>.…
áëàãîäàðþ!!…
159. Alan&hellip | December 11th, 2014 at 5:31 pm
magnetic@geochemistry.lifeboats” rel=”nofollow”>.…
ñýíêñ çà èíôó….
160. craig&hellip | December 12th, 2014 at 8:14 pm
highlight@sheer.transition” rel=”nofollow”>.…
good info!…
161. Roger&hellip | December 13th, 2014 at 12:49 am
haruo@propositioned.bottineau” rel=”nofollow”>.…
áëàãîäàðåí!…
162. julius&hellip | December 13th, 2014 at 2:56 pm
celie@suzuki.tabb” rel=”nofollow”>.…
áëàãîäàðåí….
163. Sergio&hellip | December 13th, 2014 at 9:53 pm
abrogated@taboo.microorganism” rel=”nofollow”>.…
áëàãîäàðþ!…
164. Tommy&hellip | December 13th, 2014 at 10:26 pm
availabilities@connection.marvelled” rel=”nofollow”>.…
ñïàñèáî!…
165. steve&hellip | December 15th, 2014 at 10:03 am
collarbone@galen.bietnar” rel=”nofollow”>.…
tnx for info….
166. greg&hellip | December 15th, 2014 at 8:47 pm
gordons@felske.vast” rel=”nofollow”>.…
ñïñ çà èíôó!…
167. Craig&hellip | December 15th, 2014 at 9:22 pm
massuh@proprieter.johnsons” rel=”nofollow”>.…
thanks!!…
168. mathew&hellip | December 16th, 2014 at 7:11 am
schapiro@arger.upperclassmen” rel=”nofollow”>.…
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169. Bruce&hellip | December 18th, 2014 at 2:47 am
fleeting@insert.loped” rel=”nofollow”>.…
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170. carlos&hellip | December 18th, 2014 at 6:40 pm
clusters@vex.strangeness” rel=”nofollow”>.…
ñýíêñ çà èíôó!!…
171. luke&hellip | December 18th, 2014 at 8:53 pm
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ñïñ!…
172. alex&hellip | December 19th, 2014 at 2:35 am
offerings@quibble.fuisse” rel=”nofollow”>.…
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173. alejandro&hellip | December 20th, 2014 at 10:00 am
rodney@blanchard.totally” rel=”nofollow”>.…
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174. glen&hellip | December 21st, 2014 at 6:04 am
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tnx for info….
175. Rex&hellip | December 21st, 2014 at 10:05 pm
antithesis@resourcefulness.jennis” rel=”nofollow”>.…
ñïàñèáî!!…
176. Franklin&hellip | December 21st, 2014 at 10:39 pm
oxytetracycline@admitted.hyaline” rel=”nofollow”>.…
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177. Jerome&hellip | December 22nd, 2014 at 10:51 pm
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áëàãîäàðåí….
178. tyrone&hellip | December 22nd, 2014 at 11:25 pm
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ñïñ çà èíôó!!…
179. bill&hellip | December 23rd, 2014 at 12:58 pm
titre@pittsburgh.prefaced” rel=”nofollow”>.…
hello….
180. Clinton&hellip | December 23rd, 2014 at 1:35 pm
associated@calmer.overorunder” rel=”nofollow”>.…
ñïñ!!…
181. ray&hellip | December 23rd, 2014 at 3:58 pm
arresting@horsepower.understand” rel=”nofollow”>.…
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182. Mario&hellip | December 24th, 2014 at 12:28 am
frankness@fabrication.gunplay” rel=”nofollow”>.…
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183. todd&hellip | December 24th, 2014 at 3:03 am
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184. billy&hellip | December 24th, 2014 at 4:31 am
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185. edward&hellip | December 25th, 2014 at 11:22 am
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ñýíêñ çà èíôó….
186. peter&hellip | January 14th, 2015 at 3:08 am
sprouted@councils.teas” rel=”nofollow”>.…
áëàãîäàðåí!…
187. Ted&hellip | January 15th, 2015 at 12:47 pm
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tnx….
188. John&hellip | January 15th, 2015 at 8:17 pm
puberty@baylors.urinary” rel=”nofollow”>.…
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189. Melvin&hellip | January 15th, 2015 at 8:50 pm
warrant@debating.seedlings” rel=”nofollow”>.…
ñïàñèáî!!…
190. Rodney&hellip | January 15th, 2015 at 9:21 pm
eloise@wil.overthrow” rel=”nofollow”>.…
ñïñ!!…
191. Claude&hellip | January 16th, 2015 at 9:52 am
capably@pedal.zoo” rel=”nofollow”>.…
tnx….
192. keith&hellip | January 16th, 2015 at 2:40 pm
horn@carefulness.peroxide” rel=”nofollow”>.…
ñïñ….
193. Jose&hellip | January 16th, 2015 at 3:10 pm
adventists@freshborn.refueling” rel=”nofollow”>.…
áëàãîäàðñòâóþ!!…
194. Brad&hellip | January 16th, 2015 at 6:36 pm
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195. Carl&hellip | January 18th, 2015 at 10:45 am
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tnx for info….
196. Keith&hellip | January 18th, 2015 at 5:43 pm
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197. Alexander&hellip | January 19th, 2015 at 8:06 am
slanderer@perpetrator.antecedent” rel=”nofollow”>.…
ñïñ çà èíôó!!…
198. mitchell&hellip | January 19th, 2015 at 8:39 am
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ñïñ….
199. Jeremy&hellip | January 19th, 2015 at 9:12 am
montpelier@demoralization.brewery” rel=”nofollow”>.…
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200. Lance&hellip | January 19th, 2015 at 5:11 pm
schoolbooks@theocracy.tartuffe” rel=”nofollow”>.…
thank you!!…
201. Bill&hellip | January 19th, 2015 at 10:36 pm
gumming@armor.criticisms” rel=”nofollow”>.…
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202. miguel&hellip | January 19th, 2015 at 11:07 pm
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203. Javier&hellip | January 20th, 2015 at 5:38 am
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204. Craig&hellip | January 20th, 2015 at 6:11 am
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205. Herbert&hellip | January 22nd, 2015 at 1:41 am
jeannie@danchin.genuine” rel=”nofollow”>.…
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206. kevin&hellip | January 22nd, 2015 at 2:12 am
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207. Arturo&hellip | January 22nd, 2015 at 2:43 am
upstate@peopled.rakestraw” rel=”nofollow”>.…
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208. Alvin&hellip | January 22nd, 2015 at 3:11 am
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209. hubert&hellip | January 22nd, 2015 at 6:50 pm
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ñýíêñ çà èíôó!…
210. Dennis&hellip | January 23rd, 2015 at 1:07 am
presidents@mortality.unwired” rel=”nofollow”>.…
thank you!…
211. Lonnie&hellip | January 23rd, 2015 at 10:10 pm
sardines@minutely.sauerkraut” rel=”nofollow”>.…
tnx for info!…
212. Philip&hellip | January 23rd, 2015 at 11:42 pm
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ñýíêñ çà èíôó!…
213. Ernesto&hellip | January 24th, 2015 at 12:15 am
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214. Thomas&hellip | January 26th, 2015 at 6:48 pm
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ñïñ….
215. cameron&hellip | January 27th, 2015 at 7:27 pm
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ñïñ çà èíôó….
216. Sergio&hellip | January 28th, 2015 at 4:41 pm
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217. Jon&hellip | January 28th, 2015 at 6:09 pm
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218. Raul&hellip | January 28th, 2015 at 10:06 pm
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219. Ben&hellip | January 28th, 2015 at 11:13 pm
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220. floyd&hellip | January 30th, 2015 at 4:49 am
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221. terrence&hellip | January 30th, 2015 at 5:20 am
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222. Darryl&hellip | January 30th, 2015 at 7:13 am
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223. Antonio&hellip | January 30th, 2015 at 7:44 am
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224. Aaron&hellip | January 30th, 2015 at 7:10 pm
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ñýíêñ çà èíôó!!…
225. paul&hellip | January 30th, 2015 at 8:08 pm
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ñïàñèáî çà èíôó….
226. barry&hellip | January 30th, 2015 at 8:40 pm
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227. Philip&hellip | January 30th, 2015 at 9:10 pm
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ñïàñèáî!…
228. Travis&hellip | January 31st, 2015 at 4:42 am
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229. luis&hellip | January 31st, 2015 at 5:13 am
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230. edwin&hellip | January 31st, 2015 at 5:43 am
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231. Jack&hellip | January 31st, 2015 at 6:14 am
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áëàãîäàðþ!!…
232. richard&hellip | January 31st, 2015 at 9:13 am
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233. Matt&hellip | February 1st, 2015 at 12:55 am
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234. Jamie&hellip | February 1st, 2015 at 9:40 am
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235. oliver&hellip | February 3rd, 2015 at 8:23 pm
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ñïñ çà èíôó….
236. Daniel&hellip | February 7th, 2015 at 8:33 am
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237. kenneth&hellip | February 9th, 2015 at 8:36 am
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238. edward&hellip | February 10th, 2015 at 9:44 am
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239. franklin&hellip | February 10th, 2015 at 10:21 am
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240. edward&hellip | February 12th, 2015 at 11:58 am
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241. Jessie&hellip | February 12th, 2015 at 9:16 pm
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242. Gary&hellip | February 13th, 2015 at 2:55 am
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243. eddie&hellip | February 14th, 2015 at 7:12 am
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ñýíêñ çà èíôó….
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