FDA issues warnings to companies claiming to cure H1N1 virus
ROCKVILLE, Md. The Food and Drug Administration last month issued 35 warning letters to companies promoting a product for the treatment or prevention of the novel H1N1 influenza virus, suggesting that the agency is paying close attention to Internet marketers who may be hoping to capitalize on consumer fears of the “swine flu.”
Marketers were given 48 hours to respond to the warning letters.
“Firms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws,” the agency warned.
For those companies located outside the United States, the agency promised to intercept and refuse entry of their products at the border.
“This is to advise you that the United States Food and Drug Administration reviewed your web site at the Internet address http://www.fitura.com/ on May 15, 2009,” the agency stated in its most recent letter emailed to Fitura. “The FDA has determined that your web site offers a product for sale [Power Immune] that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA.”
The agency noted it is paying close attention to the marketing and sale of unapproved H1N1-related products partly on the request of the Centers for Disease Control and Prevention. However, the agency also noted that these products are “a potentially significant threat to the public health.”
Calif. Senate passes pseudoephedrine bill, , receives opposition from CHPA
SACRAMENTO, Calif. The California Senate on Tuesday voted 22-10 in favor of a bill that would reclassify pseudoephedrine, already sold behind-the-counter at pharmacy, as a prescription-only drug in an effort to further thwart the illicit manufacture of methamphetamine.
The bill, S.B. 484, will now be considered by the California Assembly.
In favor of the bill were many of the state’s law enforcement associations and organizations; opposed to the bill were the Consumer Healthcare Products Association and several retail pharmacies like Rite Aid.
“While CHPA strongly supports efforts to address the methamphetamine problem in this country, we believe that today’s vote by the California Senate serves as a well-intentioned but misguided approach,” CHPA released in a statement following the ruling. “This initiative will have little effect on the trafficking of methamphetamine in California but will force consumers suffering nasal congestion or allergies to spend time in their doctors’ offices and waiting rooms so a cursory examination can be administered and a prescription obtained.”
CHPA suggested there are other methods that will help stem methamphetamine production in the state that do no limit consumer access to OTC PSE, such as an electronic sales tracking system that could help prevent a practice known as “smurfing” — where people circumvent the maximum amount of PSE that can be sold legally by purchasing those products across several adjacent pharmacies.
Common antacids raise risk of fracture
NEW YORK Common antacids known as proton-pump inhibitors and histamine-2 receptor antagonists have been found to increase risk of hip and thigh fractures.
Common proton pump inhibitors (e.g. Prilosec, Prevacid and Nexium), as well as histamine-2 receptor antagonists, Pepcid, Tagamet and Zantac, are known for easing stomach acid.
A study by Douglas A. Corley, in addition to prior findings, confirmed that such drugs generally used to treat gastroesophageal reflux disease increase users’ risk of foodborne infections and fractures.
Corley’s study collected data on more than 160,000 individuals who use, as well as do not use, these medications. Data showed people with hip fractures were 30% more likely to be taking proton pump inhibitors over two years, and those suffering from hip fractures were 18% increased fracture if taking histamine-2 receptor antagonists.
According to Elton Strauss, chief of Orthopaedic Trauma and Adult Reconstruction at Mount Sinai School of Medicine in N.Y.C, “The key to this article is awareness for both the physician prescribing the meds and the patient taking them. It is the classic problem in medicine of risks versus benefits.”