ApothéCure Inc.
From Wikipedia, the free encyclopedia
ApothéCure Inc. is a Dallas, Texas-based compounding pharmacy that specializes in custom compounded formulas and nutritional supplements for both patients and physicians. The business began pharmacy operations in 1991. ApothéCure is a sister corporation of the Texas Institute of Functional Medicines. ApothéCure is regulated by the Texas State Board of Pharmacy.
ApothéCure's products include compounds such as bioidentical hormones, thyroid and adrenal, ophthalmic drops, mesotherapy, prolotherapy and chelation therapy compounds. ApothéCure was referenced in Natural Health magazine in an April 2004 article,[1] and in several books, such as Digestive Wellness by Brand and Lipinski, and Suzanne Somers' The Sexy Years. ApothéCure is affiliated with several organizations, including the American Academy of Anti-Aging Medicine and the International Academy of Oral Medicine and Toxicology. Professionally, ApothéCure is a member of The International Association of Compounding Pharmacies and The International Academy of Clinical Nutritionists.
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[edit] Controversy
ApothéCure has been implicated in the March and April, 2007, deaths of three patients from the Pacific Northwest. The patients were each given intravenous colchicine, a toxic substance commonly used in naturopathic medicine,[2] for treatment of back pain. The colchicine, however, was labeled incorrectly and was ten times more concentrated than listed on the vials, resulting in toxic doses.[2][3][4] The colchicine has since been recalled as with any suspected adverse drug event.[5]
ApothéCure was investigated in 2004 following complaints that its compounds (testosterone and growth hormones) may have been illegally dispensed to patients, including a pregnant woman.[6] Pharmacy board officials found insufficient evidence to discipline the company, but issued a letter of warning.[6] In the 2007 deaths, however, there may have been several violations committed, including ApothéCure being unlicensed to sell drugs in Oregon.[6][7] In the year and a half prior to the 2007 deaths, ApothéCure made 44 total sales of injectable colchicine to Oregon health professionals without a license to distribute in Oregon.[8]
Attorneys general in Oregon and Texas have filed lawsuits against ApothéCure Inc. and the company's owner, Gary Osborn of Dallas, Texas.[9] The case is being jointly prosecuted between Oregon Attorney General Hardy Myers and Texas Attorney General Greg Abbott, asserting that "the company failed to follow standard safety practices and exceeded their authorized scope of practice as a compounding pharmacy".[7] According to Meyers, ApotheCure's error reflected a pattern of substandard care and was not an isolated incident.[7] The Texas suit alleges that the pharmacy "failed to use proper manufacturing practices, employed incorrect labels and made exaggerated claims about the benefits of its dietary supplements."[9]
The Pennsylvania Department of Health issued a statewide alert in 2004 after three Pennsylvania patients had reactions following intravenous injections of the ApothéCure-supplied drug phosphatidylcholine.[6][10]
[edit] Settlements
ApothéCure reached a settlement with the Oregon attorney general in April 2008. The settlement requires ApothéCure to pay $100,000 to the state, and a $500,000 civil penalty if the company wishes to sell products in Oregon again.[8] ApothéCure must also refund money from all of its 222 sales to Oregon consumers from 2004 through 2007.[8]
Wrongful death lawsuits were filed against ApothéCure by the families of two of the colchicine victims; both families have reached confidential settlements with ApothéCure, while the third family is negotiating a settlement with the the company.[8]
[edit] References
- ^ "The new pharmacy: these 21st-century health centers combine the full range of pharmaceuticals with alternative treatments, natural products and advice from nurses, nutritionists and naturopaths", Natural Health, April, 2004, Nora Isaacs; retrieved 14 December 2007
- ^ a b "Deaths sound an Rx alert", The Portland Tribune, April 20, 2007
- ^ "Dallas company blamed in 3 deaths", The Dallas Morning News, Associated Press, April 27, 2007
- ^ "Bad medicine led to deaths", The Portland Tribune, April 27, 2007
- ^ FDA - MedWatch - Recall Of Compounded Injectable Colchicine- All Strengths, Sizes and Lots
- ^ a b c d "Drug firm has history", The Portland Tribune, May 4, 2007
- ^ a b c "Oregon, Texas Sue Pharmacy Over Deaths", Houston Chronicle/Associated Press, Dec. 12, 2007
- ^ a b c d "State, drug maker settle", The Portland Tribune, April 18, 2008
- ^ a b Plaintiff's position against Apothecure, retrieved 12 December 2007
Texas Attorney General’s press release on case, retrieved 12 December - ^ "PENNSYLVANIA DEPARTMENT OF HEALTH: HEALTH ADVISORY #15", August 6, 2004