The most recent FDA UPDATE following the July 2011 and September 2011 Safety Communications document regarding the health risks of surgical mesh was released today. The FDA states that serious complications are not rare and that it is not clear that surgical mesh is more effective than non-mesh repair in transvaginal repair of pelvic organ prolapse. The document also states that the FDA is considering reclassifying surgical mesh from a Class II medical device to Class III medical device. Class III devices are defined by the fact that the "general controls are not adequate to provide reasonable assurance of safety and effectiveness and there is not sufficient information to establish special controls that would provide such assurance.

Urogynecologic Surgical Mesh Implants

Source:  www.fda.gov

Traumatic brain injury (TBI) is a serious public health problem in the United States.  Each year, traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability. 

National TBI (Traumatic Brain Injury) Estimates 
Each year, an estimated 1.7 million people sustain a TBI annually.1 Of them:

• 52,000 people die as a result of TBI
• 275,000 people are hospitalized as a result of TBI
• 1.365 million people, nearly 80%, are treated and released from an emergency departmen

http://www.traumaticbraininjury.com/

Source:  www.traumaticbraininjury.com

The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

This safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study1, described in FDA's September 2010 ongoing safety review and in the Data Summary below. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone. FDA is ...

The US Drug Watchdog wants to hear from any user of the diabetes drug called Actos, who developed bladder cancer. According to the AP, "The FDA has issued a warning that Actos may be linked to an increased risk of bladder cancer. Meanwhile, both Germany and France have suspended sales of Actos. The Actos suspension is effective July 11, 2011. Actos (pioglitazone), along with another diabetes drug made by Takeda Pharmaceutical, Competact, came under fire in Europe after a study revealed an increased risk for bladder cancer among diabetes patients who were taking the medication." The US Drug Watchdog says, "We want to hear from any user of the diabetes medication called Actos, if they have developed bladder cancer. If after using Actos you developed bladder cancer please call our group immediately at 866-714-6466." 

http://USDrugWatchdog.Com

Source: www.usdrugwatchdog.com

The FDA Commissioner is revoking the agency’s accelerated approval of the breast cancer indication for Avastin (bevacizumab), manufactured by Genentech.   Avastin used for metastatic breast cancer has not been shown to provide a benefit, in terms of delay in the growth of tumors, that would justify its serious and potentially life-threatening risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life.

The decision involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin's product labeling.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

FDA News Release on Avastin

Avastin was approved for metastatic ...