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April Through June 2013 April through June 2013 Updated Warnings—Current Drugs Fraudulent Versions of Botox: The FDA is alerting healthcare practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are Codeine Sulfate – Warning: The FDA has issued a being sold to U.S. medical practices. The outer carton is Black Box Warning to the labeling for codeine sulfate oral counterfeit, while the vial inside is labeled as a foreign solution. There is a risk of respiratory depression and version of Botox—which is not FDA-approved for sale in death in children receiving this product after certain the United States. These products are being sold by surgeries—tonsillectomy and/or adenoidectomy. (5/9/13) unlicensed suppliers who are not part of the legitimate US supply chain. The FDA cannot confirm that the Compounding Shop: Lack of Sterility Assurance of manufacture, quality, storage, and handling of these Drug Products: The FDA is alerting healthcare products follow US standards. These fraudulent products providers, hospital supply managers, and pharmacists that are considered unsafe and should not be used. the FDA’s preliminary findings of practices at The The company selling the fraudulent versions of Botox goes Compounding Shop of St. Petersburg, Fla., raise concerns by the names “Online Botox Pharmacy,” about a lack of sterility assurance for sterile drugs “Onlinebotox.com,” and “Onlinebotox.” At the time this produced at and distributed from this site; therefore, these alert was issued, the company did not appear to be selling products should not be administered to patients. If a drug its products over the internet—instead, the company has product marketed as sterile has microbial contamination, it been using “blast faxes” to solicit sales from medical potentially places patients at risk of serious infection. practices, typically selling products at prices below those of The FDA has advised the firm that it is in the best interest FDA-approved products. As is the case with many of public health to take action to remove all sterile products companies that sell fraudulent products, Online Botox from the market. The Compounding Shop has informed Pharmacy uses a US return address when sending packages the FDA that it is recalling sterile products and is in the to medical practices, even though the products are from process of notifying customers. foreign sources. Medications purchased from foreign or The FDA is basing this warning on a recent inspection of unlicensed sources may be misbranded, adulterated, The Compounding Shop. The investigators observed poor counterfeit, contaminated, improperly stored and sterile production practices that raise concerns about a lack transported, ineffective, and/or unsafe. Medical practices of sterility assurance of The Compounding Shop’s sterile that purchase and administer illegal and unapproved drug products. medications from foreign sources are putting patients’ Healthcare providers and hospital staff should immediately health at risk, as patients may not be getting proper check their medical supplies, quarantine any sterile treatment. products from The Compounding Shop, not administer FDA-approved Botox for injection (100 units/vial), them to patients, and await further instructions from the manufactured by Allergan, displays the active ingredient as company regarding the recalled products. Patients who “OnabotulinumtoxinA” on the outer carton and vial. have received any product produced by The Compounding Currently, there is no indication that Allergan’s FDA- Shop and have concerns should contact their healthcare approved version is at risk, and this product should be provider. (5/8/13) considered safe and effective for its intended and approved uses. Fiorinal/Codeine #3—Warning: The FDA is alerting Suspect fraudulent products can be identified as follows: healthcare providers of the risk of respiratory depression the outer carton displays the active ingredient as and death in children related to use of Fiorinal/Codeine #3 “Botulinum Toxin Type A” OR (codeine phosphate/aspirin/ caffeine/butalbital). Such the lot numbers and expiration dates on the outer carton adverse reactions follow tonsillectomies and and accompanying vial do not match adenoidectomies. The manufacturer Watson must include Thus far, the following examples have been confirmed as a Black Box Warning on labeling/package inserts. (May fraudulent Botox. Products with any of these lot numbers 2013) and expiration dates should be considered suspect. www.AmericanHealthCare.com For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 Example 1 Example 2 • Talk to your healthcare professional about any risk factors or LOT # EXP DATE LOT # EXP DATE concerns you may have with human immune globulin C3016 C3 C3060 C3 products. 10-2014 01-2015 (carton) (carton) • Contact your healthcare professional if you develop any signs C3121 C3 (vial) 04-2015 C3121 C3 (vial) 04-2015 or symptoms of thrombosis during or after receiving human immune globulin. Signs or symptoms of thrombosis may The FDA is asking the public to report suspect Botox include: products obtained from Online Botox Pharmacy or other o pain and/or swelling of an arm or leg with warmth over questionable sources: the affected area a) Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 o discoloration of an arm or leg b) Report to OCI at o unexplained shortness of breath www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm1, or c) email to [email protected] o chest pain or discomfort that worsens on deep breathing (4/26/13) o unexplained rapid pulse o chest pain o numbness or weakness on one side of the body Warning – Human Immune Globulin Products: Healthcare professionals should be aware of the risk for The FDA is requiring manufacturers to add information on thrombosis with human immune globulin products and thrombosis to the current boxed warning in the labels of all ensure appropriate patient selection and monitoring. intravenous human immune globulin products and to add a • Discuss with your patients the risk of thrombosis associated boxed warning to the labels of all subcutaneous and with these products. intramuscular human immune globulin products to • Carefully consider risk factors when selecting patients for highlight the risk of thrombosis and to add information on treatment with human immune globulin products. its mitigation. A retrospective analysis of data from a large • Monitor patients carefully for signs and symptoms of health claims-related database, as well as continued thrombosis both at the time of infusion and after infusion postmarketing adverse event reports of thrombosis, have and encourage patients to report any signs or symptoms. strengthened the evidence for an association between the • Report adverse events involving human immune globulin products to the FDA MedWatch program. use of intravenous, subcutaneous, and intramuscular (6/10/13) human immune globulin products and the risk of thrombosis. This information necessitates a boxed Kadcyla and Potential Medication Errors: The FDA warning for the entire class of products. notified healthcare professionals that the use of the Human immune globulin products are used in a variety of incorrect nonproprietary name for the breast cancer drug conditions, both on and off-label, by healthcare Kadcyla (ado-trastuzumab emtansine) in some medication- professionals who may not be aware of the thrombosis risk related electronic systems poses a risk of mix-up with and measures that could be taken to mitigate this risk. Herceptin (trastuzumab) and may result in medication Although all human immune globulin products already errors. The dosing and treatment schedules for Kadcyla contain some information related to the risk of thrombosis and Herceptin, another breast cancer drug, are quite in the current WARNINGS and PRECAUTIONS sections of different; so confusion between these products could lead their labels, the FDA recognizes that the communication of to dosing errors and potential harm to patients. The FDA- this risk and its mitigation are not standardized. The FDA approved nonproprietary name for Kadcyla, ado- proposes that for thrombosis a more prominent placement trastuzumab emtansine, should be used; however, some of risk information and a uniform approach for third-party publications, compendia references, health communicating the risk and its possible mitigation will information systems (e.g., electronic health record systems help to reduce the occurrence of these serious adverse and systems used for pharmacy prescription processing, events: • Thrombosis may occur regardless of the route of wholesaler ordering, pharmacy ordering, etc.), and sites on administration. the Internet are incorrectly using the United States • Risk factors include: advanced age, prolonged Adopted Name (USAN), which is “trastuzumab emtansine,” immobilization, hypercoagulable conditions, history of and omitting the “ado” prefix and hyphen. Use of this venous or arterial thrombosis, use of estrogens, indwelling truncated version of Kadcyla’s nonproprietary name may central vascular catheters, hyperviscosity and cardiovascular cause confusion with Herceptin (trastuzumab). (5/6/13) risk factors. • Thrombosis may occur in the absence of known risk factors. Potiga Warning: The FDA is warning the public that the • For patients at risk
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