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Pharmacies Warned to Stop Selling Compounded Topical Anesthetics
Two Deaths Linked to the ProductsBETHESDA, college student died after having an adverse reaction to a potent anesthetic gel prepared by a pharmacy, warned the firm to stop compounding and distributing the product.
Federal regulators last week also told four other pharmacies to cease compounding and selling their topical anesthetics, which, said, the companies were marketing for general distribution rather than preparing in response to a specific prescription.
generally permits licensed pharmacies to compound products that are not commercially available, as when a patient needs a specific formulation because the person is allergic to an ingredient in the mass-marketed version.
"The agency's action is not targeting this practice," regulators stated.
However, FDA said, Triangle Compounding Pharmacy of , University Pharmacy of , Custom Scripts Pharmacy of , Hal's Compounding Pharmacy of San Diego, California, and New England Compounding Center of , "are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution."
"Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved," , director of FDA's , said in a statement.
"These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision," he added.
student Shiri Berg had a seizure in her car on December 28, 2004, after applying a topical gel prepared by Triangle Compounding Pharmacy containing 10% lidocaine, 10% tetracaine, and an unknown amount of phenylephrine.
The student lapsed into a coma and never regained consciousness before dying on January 5, according to attorneys representing Berg's family.
A February 2 autopsy report indicated that Berg died of anoxic brain injury due to lidocaine toxicity.
Berg bought two 30-g tubes of the anesthetic gel on December 27, 2004, for $40 each from Premier Body, a medical spa in , where the student planned to have a laser hair removal procedure the next day, according to attorneys for the Berg family.
Berg did not have a prescription for the compounded medication, which was labeled as Lasergel Plus 10/10 Gel.
Triangle's Lasergel and Lasergel Plus 10/10 are products that are "misbranded," FDA stated in a December 4 warning letter to the firm, because the labeling on the topical anesthetics "fails to bear adequate directions for their use" and "fails to reveal the consequences that may result from the use of these articles under the conditions of use described in their labeling."
Adverse events associated with "high systemic exposure" to lidocaine and tetracaine include seizures and cardiac arrhythmias, regulators noted, adding that tetracaine is associated with a higher rate of allergic reactions than other anesthetics, such as lidocaine.
Factors that may increase systemic exposure, officials said, are the time and surface area of exposure, "particularly when the area of application is covered by an occlusive dressing," as was the circumstance in Berg's case.
The risk of systemic toxicity from topical application of an anesthetic is greatest in small children and in patients with preexisting heart disease, FDA said, adding that patients with severe hepatic disease have a higher-than-normal risk of toxicity because they cannot metabolize local anesthetics.
, a vasoconstrictor agent present in the Lasergel Plus 10/10 product, can cause serious adverse events related to hypertension and vasoconstriction, regulators noted.
In a warning letter to University Pharmacy, FDA noted that the firm's compounded lidocaine–tetracaine product, labeled as Photocaine Gel, was linked to the November 1, 2004, death of a 25-year-old woman.
Blanco Bolanos reportedly lapsed into a coma in January 2002 after applying Photocaine to her legs in preparation for a laser hair removal treatment. The woman spent nearly two years in a coma before dying.
In a MedWatch notice circulated Friday, FDA alerted health care professionals and consumers about the serious public health risks related to compounded topical anesthetic creams.
The agency advised consumers who have questions or concerns about compounded topical anesthetics to contact their health care providers.
Officials also urged consumers and health care practitioners to notify FDA of any complaints or problems associated with compounded topical anesthetics or any other compounded products at (800) FDA-1088 or by completing a form on the MedWatch website. - See more at: http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=2383#sthash.daAmdXNk.dpuf Dec 2006—Nearly two years after a
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