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NABP e-News: May 13, 2009
NABP Position Paper Calls for Action Against Proliferation of Rogue Internet Drug Outlets
NABP released a position paper on May 5, 2009, examining the flagrant lawlessness of Web sites selling prescription medicine over the Internet. “To see why this ‘wild west’ of an electronic marketplace is a problem, one need only follow the trail of dead and injured patients,” the paper asserts. The “State of the Internet: NABP Position Paper on the Continued Proliferation of Rogue Internet Drug Outlets” calls to task the various parties whose activities allow this trend to continue and challenges lawmakers and regulators to rein in this dangerous underground marketplace. The paper is cited and NABP quoted in Northwestern University’s Medill Reports. The complete position paper is posted under News on the NABP Web site.
NABP Awards First Vet-VIPPS Accreditation to VetRxDirect, Inc
NABP recently awarded the first Veterinary-Verified Internet Pharmacy Practice Sites™ (Vet-VIPPS™) accreditation to VetRxDirect, Inc. Online veterinary pharmacy practice sites that obtain Vet-VIPPS accreditation exhibit their willingness to operate legitimately, assuring animal care providers that they are purchasing drugs and devices from a facility that meets the licensing requirements of the state in which the facility is based and each state to which it dispenses pharmaceuticals. Read more in the May 11, 2009 NABP news release.
Amplified Warnings Required for Testosterone Gel, Botulinum Toxin, OTC Pain Relievers
Food and Drug Administration (FDA) is requiring the manufacturers of several prescription and over-the-counter (OTC) drug products to turn up the volume on their warning labels.
- Testosterone Gel: FDA is requiring manufacturers of two prescription topical testosterone gel products, AndroGel® 1% and Testim® 1%, to include a boxed warning on the products' labels. FDA has received reports of adverse effects in children who were inadvertently exposed to testosterone through secondary exposure to these products. Read more in the May 7, 2009 FDA news release.
- Botulinum Toxin: Prompted by reports of serious adverse events, FDA is requiring safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS) for all botulinum toxin products. Read more in the April 30 FDA news release.
- Pain Relievers: FDA has issued a final rule requiring manufacturers of OTC pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage. Products of concern include acetaminophen and nonsteroidal anti-inflammatory drugs (eg, aspirin, ibuprofen, naproxen, and ketoprofen), as well as products containing these ingredients. Read more in the April 28 FDA news release and in the April 28 Federal Register.
SAMHSA, FDA Join Forces to Educate Public on Safe Use of Methadone
Substance Abuse and Mental Health Services Administration (SAMHSA) and FDA recently launched an initiative to help ensure the safe use of methadone. A prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines, methadone is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication. Read more on the SAMHSA Web site.
Webinar Addresses Risk Evaluation and Mitigation Strategies, Opioid Analgesics
The FDA Center for Drug Evaluation and Research (CDER) and Office of Special Health Issues (OSHI) have developed a Webinar to better inform stakeholders about general issues related to REMS and specific issues related to REMS for certain opioid analgesics. Read more on the CDER Web page.
Hydroxycut Products Recalled in Response to Death, Risk of Liver Injury
Iovate Health Sciences Inc has recalled Hydroxycut® products associated with a number of serious liver injuries. FDA received 23 reports of health problems ranging from jaundice and elevated liver enzymes to liver damage requiring transplant, as well as other health problems, associated with the use of these products. Read more in the May 1 FDA news release.
