Authorities seize over $100,000 in unapproved drugs marketed as natural supplements
Washington U.S. Marshals seized more than 14,000 dosage units of natural supplements, valued at more than $100,000, titled: Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus and Lady Shangai at the request of the Food and Drug Administration. The products were marketed as treatments for erectile dysfunction, impotency and/or sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
The packages of these products did not list the drug ingredients on the label and when tested by the FDA, it was discovered that the ingredients were FDA-approved drugs for ED. The agency started looking into the supplements after receiving a consumer complaint.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin, according to the FDA, and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs.
Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company, Shangai Distributors, did not take any action to correct the violations, according to the FDA.
The FDA issued a press release on Dec. 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.
Teva pays $7.5 million to settle IVAX lawsuit with Depomed
MENLO PARK, Calif. Depomed will receive a one-time payment of $7.5 million from Teva Pharmaceuticals generic unit IVAX in relation to a settlement of a patent lawsuit, according to published reports.
Depomed had sued IVAX in January 2006 claiming patent infringement by IVAX’s Glucophage XR, a diabetes medication.
Under the terms of the settlement, Depomed will also get up to $2.5 million in royalties, for granting Teva a non-exclusive license allowing it to continue marketing the generic version of Glucophage XR.
SynaMed launches free online PHR
NEW YORK SynaMed has launched its free online personal health record, which will be available to all patients.
“SynaMed simplifies record keeping so that patients do not have to rely on memory. A personal health record can also provide lifesaving medical information when a patient is not able to speak for themselves,” according to Holly DeMuro, SynaMed’s director of operations. SynaMed’s personal health record system uses a Web browser-based application service provider model, which allows patients access anytime, from anywhere with Internet connection.
Patients using SynaMed’s personal health record will be able to record all of their medical history, doctor’s visits, check insurance coverage for medications, and receive health maintenance reminders about wellness issues and checkups. “Going forward, SynaMed will be expanding the Personal Health Record to include overall health information such as mood, weight, diet, and exercise trackers. This feature will be the first complete online wellness center,” DeMuro said.
In addition to a state of the art PHR, SynaMed offers a free fully integrated electronic medical record and practice management system to medical practitioners.