Health officials are investigating whether four people hospitalized over the weekend are suffering complications from facial injections administered at the Advanced Integrated Medical Center in Fort Lauderdale. The two couples are currently being treated for botulism. An average of 110 cases of botulism are reported each year in the United States, according to the Center for Disease Control. Symptoms include weakness and trouble breathing. State and federal health officials investigating the cases said they had not determined whether the four patients were injected with Botox®, another brand called Myoblock®, or some other substance, such as a look-alike product made overseas and sold in America without federal approval. Officials of the U.S. Food and Drug Administration said they have fielded some complaints about unapproved injectibles coming in from overseas, and have seized some in South Florida.
It is still undetermined who administered the shots at the Advanced Integrated Medical Center. According to the Florida Department of Health, Dr. Shelly Wolland, one of the physicians working at the clinic, has a restricted license. Wolland is 'prohibited from dispensing, administering or injecting any medication except if her patient's life was in danger" Wolland injected unlabeled, improperly stored medication' into patients.
Allergan, which produces Botox®, is performing an investigation into the sales history with the clinic. Stephanie Fagan, a spokeswoman for Allergan, released the following statement. 'Allergan has reviewed all manufacturing and quality assurance processes involved with the vials, and no deficiencies or irregularities were found,' the statement said. 'We are confident in the worldwide safety and manufacturing quality of Botox®."
Federal officials have opened a criminal investigation into the outbreak. According to the Wall Street Journal, investigators are studying documents and computers seized over the weekend from two Arizona companies. They're trying to determine whether the companies supplied the botulinum toxin, or substance used to make it.
The Miami Herald says that search warrants were served last weekend at the Tucson headquarters of a company called Powderz Incorporated and at its sister company, Toxin Research International.