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FDA finds medical device recalls nearly doubled in 10 years

In Medical Devices on March 29, 2014 at 6:03 pm

The Wall Street Journal says a report to be released today will spotlight the increasing number of problems.

The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade
Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday. The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls, up from seven in 2003 (Burton, 3/21).

http://online.wsj.com/news/articles/SB10001424052702304756104579452062734883356

 

Testosterone Lawsuits: Low-T Replacement Drugs Linked to Heart Injuries

In Low Testerone on March 29, 2014 at 5:55 pm

A 2014 medical study conducted by a team of leading researchers from UCLA and the U.S. National Cancer Institute found a two-fold increased risk of heart attacks in men 65 and older in the 90 days following the first prescription. That same study also showed adverse risks for men younger than 65 who had pre-existing cardiovascular disease. That group had a two- to three-fold increased risk of a heart attack in the 90 days following the first prescription. -

A November 2013 study, conducted on older men in the U.S. Veterans Affairs health system, many of whom had underlying cardiovascular disease, demonstrated that there is a 30 percent increased risk of stroke, heart attack and death in the group that had been prescribed testosterone therapy drugs. The findings were reported in The Journal of the American Medical Association.

 

The products are:

 

  • AndroGel – Manufactured by AbbVie
  • AndroDerm – Manufactured by Actavis
  • Axiron – Manufactured by Eli Lilly and Company
  • Bio-T-Gel – Manufactured by Teva Pharmaceuticals
  • Fortesta – Manufactured by Endo Pharmaceuticals
  • Striant – Manufactured by Columbia Laboratories
  • Testim – Manufactured by Auxilium Pharmaceuticals
  • Testopel – Manufactured by Auxilium Pharmaceuticals
  • Delatestryl – Manufactured by Indevus Pharmaceuticals
  • Depo-Testosterone – Manufactured by Pharmacia & Upjohn Company

Tapping a medical-records database of 55,593 men who received prescriptions for testosterone from 2006 to 2010, the current research compared the subjects to themselves before and after receiving their first testosterone prescription.

And they compared the men who got prescriptions for testosterone to a similar group of men who got a first prescription for an erectile dysfunction medication. Men in both of those two groups tend to be of similar age, have similar health problems, and complain of similar symptoms, and so are comparable. But since erectile dysfunction drugs do not affect hormone balance and work in different ways than do testosterone supplements, the researchers who observed differences in the two groups’ heart attack rates would point to a drug effect, not just a correlation between those taking a drug and a negative outcome.

By both measures, older men on testosterone, and younger ones with established heart disease, were significantly more likely to suffer a heart attack shortly after starting a testosterone prescription.

The authors said that large clinical trials should be conducted to clarify which men might incur risks from testosterone supplementation that outweighed its benefits. Until those are conducted and the results are in, they wrote, physicians counseling men who seek testosterone supplements “might be well advised to include serious cardiovascular events in their discussion with patients of potential risks, particularly for men with existing cardiovascular disease.”

 

Pure Edge Nutrition, LLC Issues Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein

In FDA REcalls on March 29, 2014 at 5:46 pm

Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons, Phenophthalein is used medicinally as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.

Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the Sibutramine and Phenophthalein were included as ingredients by the manufacturer.

All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:

Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.

Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.

Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.

Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.

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