by certifiedbug on March 10, 2010
in News
FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures
03-10-2010
Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast.
Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.
Meanwhile the FDA is recommending patients should not stop taking their medication unless told to do so by their healthcare professional.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
http://certifiedbug.com/blog/2010/03/09/osteoporosis-drugs-possible-effects-of-long-term-use/
Merck Responds to News Reports about FOSAMAX® (alendronate sodium) Tablets
http://merck.com/newsroom/company-statements/2010_0310.html
AAOS: American Academy of Orthopaedic Surgeons®: Quantity vs. quality: Long-term use of bone-building osteoporosis drugs
Bisphosphonate treatments, proven to enhance bone density and reduce fracture incidence in post-menopausal women, may adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years, according to preliminary research presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).
http://www6.aaos.org/news/pemr/releases/release.cfm?releasenum=877
by certifiedbug on March 9, 2010
in News
Pharmaceutical company Merck’s patent on the Osteoporosis drug “Fosamax” expired in February 2008 leaving the gate open for generic drug makers to roll out low-cost versions.
The brand “Fosamax” is expensive, Merck & Co reported second quarter 2009 sales of $277 million for FOSAMAX alone. Presumably with generics available more people will be able to afford to fill a prescription but it might pay to do some homework first.
Last night ABC turned the spotlight on this class of drugs known as bisphosphonates.
World News: Long-term Use of Popular Class of Osteoporosis Drugs
Frozen Bone Syndrome+Fosamax, Esophagus Cancer+Fosamax, Heart+Fosamax, Jaw Death+Fosamax, Osteonecrosis of the Jaw+Fosamax typed into a search engine will return pages of hits.
Alix Spiegel, December 21, 2009. How A Bone Disease Grew To Fit The Prescription
New York Times, July 15, 2008. Drugs to Build Bones May Weaken Them
Australian Broadcasting Corporation, November 12, 2007. Concern over osteoporosis drug
FDA MedWatch Safety Alert, January 7, 2007. Severe Pain with Osteoporosis Drugs
July 29, 2009. Statement by Merck & Co., Inc., Regarding FOSAMAX® (alendronate sodium) and Rare Cases of Osteonecrosis of the Jaw
http://www.merck.com/newsroom/news-release-archive/product/fosamax_statement.html
FDA News Release
Dec. 29, 2009
FDA Warns Public of Continued Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.
The criminals call the victims — who in most cases previously purchased drugs over the Internet or via “telepharmacies” — and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.
The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration
FDA article here
http://certifiedbug.com/blog/tag/fda/
FDA NEWS RELEASE
The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.
During the effort, the FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.
The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names.
The goal of the IIWA is to protect public health by:
- increasing the public’s awareness about the dangers and risks associated with purchasing drugs and medical devices from Web sites
- identifying producers and distributors of counterfeit and illegal pharmaceutical products and medical devices
- targeting these individuals and businesses with civil or criminal action
- seizing counterfeit and illegal products and removing them from the supply chain
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm
Certifiedbug: March 30, 2007 Fake pharmaceuticals on-line, buyer beware
Brian Krebs, Washington Post FDA targets rogue Internet pharmacies
