Consumer group sues FDA for stronger antibiotics warning
WASHINGTON Public Citizen, a consumer group, is suing the Food and Drug Administration in an effort to force the agency to act on a petition seeking stronger warnings about the risk of tendon rupture associated with a class of antibiotics called fluoroquinolones according to the Associated Press. Cipro and Levaquin are types of fluoroquinolones.
In August 2006, Public Citizen filed a petition with the agency stating that the drugs should carry a “black-box” warning, as should medication guides often given to consumers with their prescriptions. The drug labels do warn of the risk of tendon ruptures but the warning is not contained in a black box, which is considered the FDA’s toughest warning.
In the petition, Public Citizen said, according to its review of the FDA’s adverse event database, that 262 cases of tendon ruptures, 258 cases of tendinitis and 274 cases of other tendon disorders were reported between November 1997 and Dec. 31, 2005, associated with fluoroquinolone antibiotics. Of those, 175, occurred since 2003. About 61 percent of the reported tendon problems were associated with Levaquin and 23 percent were associated with Cipro. Since 2005, Public Citizen said an additional 74 tendon ruptures have been reported to the FDA.
The lawsuit, filed Thursday in the U.S. District Court for the District of Columbia, says the agency is violating the Administrative Procedure Act by not acting upon the petition.
FDA approves Depomed’s 1,000 mg Glumetza
MENLO PARK, Calif. Depomed has received approval from the Food and Drug Administration for a 1,000 mg strength of Glumetza tablets. Glumetza is used as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes.
“This approval is good news for patients with Type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day,” stated Carl Pelzel, president and chief executive officer of Depomed. “The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2,000 mg/day as tolerated. We believe this 1,000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1,000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future.”
Depomed acquired exclusive U.S. rights to the 1,000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Glumetza had sales of $3.8 million in the third quarter of 2007.
Ivans launches LIME Medicare Internet solution
STAMFORD, Conn. Ivans, a technology company that provides Medicare connectivity solutions and services has unveiled its new product, an Internet solution for healthcare providers that processes Medicare transactions, called LIME.
The goal of the program will be to save providers time and money through its elimination of manual searches and by streamlining the claims process so claims are paid faster and more accurately. The program is approved by the Centers for Medicare and Medicaid Services and is compliant with the Health Insurance Portability and Accountability Act.
Using LIME, providers are able to process Medicare claims 10 times faster than dial-up modems. Providers indicated that while it used to take one hour to process three claims, by using the new program 30 claims can be processed during that same time period. Because this is a multi-user solution that can be used for other Medicare transactions such as eligibility and claims remittance, the time and money saved in a one-year period is equivalent to three staff members working full-time.
Currently, more than 100,000 part A and part B healthcare providers are supported by Ivans solutions.