#ACTOS has been linked to #bladder cancer. The #FDA is evaluating data and alleged link to long term use. In this story ABCNews reports on the potential for 1 in 3 Americans suffering from diabetes and why the numbers continue to rise. ACTOS is used to treat Type 2 Diabetes. A growing body of scientific evidence has linked ACTOS use to bladder cancer and heart problems. ACTOS has been banned in France & Germany by their health authorities. New Zealand is reportedly scheduling a bann as well.

However, the FDA continues to evaluate data on the safety and effectiveness of ACTOS. 

Gabriel F. Zambrano, P.A., is the author and sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is actively investigating cases of bladder cancer in users of #ACTOS for Type 2 diabetes. Previously posted information on ACTOS appears here.

(Source: abcnews.go.com)

ShoulderFlex Massager recalled due to risk of strangulation and injury. A FL physician was determined to have accidentally died while using the ShoulderFlex. The FDA is aware of other incident(s). The device should be disabled. Do not resell or gift the recalled massager. Info from the FDA here

The FDA confirmed multiple links to Colorado cantaloupe and Listeria outbreak prompting recalls.

In a continuing evaluation, the FDA issued a warning on the use of #ACTOS (#PIOGLITAZONE) and potential for increased risk of bladder cancer. The drug is manufactured by #TAKEDA. Interestingly, the use of #ACTOS has been limited in France & Germany following studies indicating it posed an increased risk. Apparently, the FDA needs more convincing.  The FDA is continuing an evaluation of data from an ongoing 10 year epidemiological study, as well as a comprehensive review of French studies.

#ACTOS is used to treat Type 2 Diabetes in combination with diet and exercise. It is also sold in combination with #metformin as #ACTOPLUS MET, #ACTOPLUS MET XR and #DUETACT (#GLIMEPIRIDE). 

Symptoms of bladder cancer include the following:

• blood or red colored urine;
• urgency or an urgent need to urinate;
• pain while urinating; and
• pain in the lower back or lower abdomen

Again, there is no #recall in the US. However, Gabriel F. Zambrano, P.A., the author and sponsor of this blog and commentary will report on any recall. Gabriel F. Zambrano, P.A. is monitoring FDA action and other news on ACTOS with a recall in mind.  Gabriel F. Zambrano, P.A., is investigating cases involving the use of ACTOS (PIOGLITAZONE) and bladder cancer. If you suffer from any of the symptoms above, you should report them to your physician and seek a diagnosis and treatment. 

For information and support relating to bladder cancer, contact or review information available from the #BCAN (Bladder Cancer Advocacy Network). The BCAN is dedicated to the support of the bladder cancer community, raising awareness, promoting cancer research and providing educational information. The estimate that bladder cancers it the 5th most diagnosed form of cancer in the US. With regard to #ACTOS, the BCAN notes as follows: “BCAN will continue to monitor the #ACTOS situation, and hopes pharmaceutical companies will be aware of bladder cancer as a potential side effect in future drug safety tests”. Report any symptoms to your physician and seek treatment. BCAN estimates that nearly 70,000 new cases of bladder cancer will be diagnosed in 2011. Further, they estimate nearly 15,000 will die. Again, report symptoms to your physicians and seek diagnosis and treatment.

A popular consumer version of a John Deere mower has been recalled due to laceration hazard after the engine has been cut off. Information on specific models is available by clicking the link above or visiting the CPSC here. These particular mowers were sold at HOME DEPOT & LOWES for about $1,200 to $2,000. 

Sadly, my office was contacted this week by someone that had several fingers amputated from their dominant hand while cleaning a different mower. However, the idea that a blade continues to spin after the mower is ‘off’ or in ‘park’ raises questions. Similarly, if an operator is off the mower and it is not in run, why would there be any need for the blade to continue to run ? This recall only reinforced my concern about the dangers presented to landscapers and operators of mowers. I am looking into the accident mentioned above and hope a simple fix of these popular John Deere mowers is possible.

Click on the image for the NYTimes story on what is in some health supplements and the counterfeit industry it has become.

(Source: youtu.be)

KTM North America has #recalled a number of their off-road motorcycles due to a fall or crash hazard.  The Murrieta, CA, based importer, in cooperation with the #CPSC is recalling a number of models due to cracks developing in their handlebars. The affected bikes are blue, yellow and white in color. They bear the HUSABERG logo and were manufactured in Austria. These cracks can lead to a rider losing control and suffering a fall or injury. Additional information on the specific models is available at the following link on the CPSC.GOV website.

Need information on recent #recalls, #recalled or defective drugs or products? Follow @RecallAttorneys on Twitter for updates. You can also visit Gabriel F. Zambrano, P.A., for information relating to ongoing investigations. 

(Source: facebook.com)

The FDA is WARNING that the SHOULDERFLEX MASSAGER poses risk of serious injury, potential strangulation and/or death. The subject product is illustrated above a ‘promotional’ video we found on YouTube this morning. Please do not recommend or promote the use of this product per the FDA Bulletin and information below.

However, the FDA has issued a Safety Communication that reports that both the FDA & CPSC are aware of at least one (1) death and one (1) near strangulation associated with the ShoulderFlex Massager. Both were reported as occurring when a necklace or clothing became caught in the device while in operation. Other reports include hair or clothing become caught in the device. 

The ShoulderFlex Massager is distributed by King International as a personal device for deep tissue massage of the neck, shoulders and back. Nearly 12, 000 devices have been sold or distributed since October 18, 2003.

Whether a #recall or retro-fitting of this device is forthcoming remains to be seen. Given the amount of time the product has been on the market, as well as secondary markets via garage sales, Craigslist, Amazon & E-Bay, we will monitor and report on this subject as information becomes available.

Please note that, the FDA is recommending that you do not use or recommend the use of this product. Rather, you dispose of the device components separately to prevent reassembly or use. The FDA is currently evaluating the manufacturer’s plan for a recall which may lead to additional bulletins or information.

Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. We hope to post additional information from the FDA or CPSC regarding this product, if any, when it is forthcoming. 

(Source: youtu.be)