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Archive for the ‘recall’ Category

Justice Department Subpoenas Allergan, Inc., Maker of Botox

Friday, March 14th, 2008

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According to Reuters, the maker of Botox, Allergan, Inc. received a subpoena from both the U.S. Justice Department and the U.S. Attorney’s Office for the Northern District of Georgia requesting documents regarding Botox and their promotional practices.

It is suspected that the subpoena is in relation to recent questions regarding the off-label use of Botox to treat disorders such as migraines and cerebral palsy.

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Botox has been used to treat limb spasticity due to cerebral palsy, which is a disorder caused from damage to the cerebellum during birth.

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In February, the U.S. Food and Drug Administration announced that they were investigating the safety of Botox after reports were received of deaths associated with Botox injections.

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Some of the reported deaths include children with cerebral palsy who were being treated with Botox. None of the reports included adults who were being treated for limb spasticity. In the United States, Botox is not approved to treat limb spasticity.

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If your child, or the child of a loved one, has suffered severe illness or disability from premature birth due to the negligence of another, contact a birth trauma attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced birth trauma lawyer will be able to evaluate if you are eligible to seek compensation.

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Baxter Recall of Heparin

Friday, March 7th, 2008
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          In February Baxter recalled thousands of bottles of the blood thinner drug heparin. The recall was issued after some of the drugs were linked to four deaths and countless allergic reactions. The Food and Drug Administration (FDA) is inspecting the Baxter facility in New Jersey, a Scientific Protein Laboratories facility in Wisconsin, and a factory in Changzhou, China for signs of contamination. There is a lot of suspicion focused on the Chinese factory, which is being inspected both independently and jointly with the United States by the Chinese State Food and Drug Administration (SFDA). Apparently, the factory in Changzhou was not inspected by the FDA because of a mix-up with names and was not inspected by the SFDA because it is currently classified as a chemical manufacturer, not pharmaceutical.
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          Though the SFDA is cooperating with the United States’ inquiry into the contamination, the cause of the bad reactions has still not been determined.