Wednesday, December 12, 2012

Despite FDA Warning, Sports Supplements Still Available Online: Study

DMAA sports supplements have been linked to at least two deaths and the U.S. Food and Drug Administration sent warning letters to 10 manufacturers last spring about a lack of data on their safety, but a new study finds these supplements can still be purchased online.

DMAA (dimethylamylamine) is a pre-workout supplement used by athletes to build muscle. Some research suggests that it may narrow blood vessels, which can elevate blood pressure, and may set the stage for a heart attack. Canada and the U.K have banned DMAA from all supplements.

Now, a small study published online Dec. 3 in the Archives of Internal Medicine reports that all 16 of the products mentioned in the FDA’s warning letters are still available through online retailers.
It’s good to know that the FDA is right on top of enforcement.

From the Journal:
The stimulant DMAA, also known as 1,3-dimethylamylamine, has been the subject of much controversy.1 In the United States, it is currently marketed as a dietary supplement, primarily in products promoted as a preworkout supplement for boosting strength, energy, and power. Two of the most prominent supplements containing DMAA are “Jack3d” and “OxyELITE Pro” (USP Labs) However, there are over 250 commercial dietary supplements containing DMAA on the market.2

Tuesday, December 11, 2012

Do Valium, Ativan, Xanax, Klonopin and Restoril Increase Pneumonia Risk?

ome studies have shown that benzodiazepine sedatives — including such drugs as Valium, Ativan, Xanax, Klonopin and Restoril — may increase susceptibility to infection. Might this risk extend to pneumonia?

THIS STUDY analyzed data on 34,661 people of all ages, including 5,895 who took benzodiazepines and 4,964 who developed pneumonia. People who took benzodiazepines were 54 percent more likely to have later contracted pneumonia than those who did not take the sedating drugs. Chances of dying were also greater among those who took benzodiazepines: 22 percent higher within 30 days of contracting pneumonia and 32 percent higher within about three years.

WHO MAY BE AFFECTED? People who take benzodiazepines. Commonly prescribed for anxiety and insomnia, the drugs are also used to relieve muscle spasticity, prevent seizures, calm agitation, sedate patients before surgery and ease alcohol withdrawal.

Does Alli Cause Liver and Kidney Damage?

Orlistat, which goes by the prescription brand name Xenical and the over-the-counter name Alli, can cause “severe toxicity” to major internal organs, says a recent study. .

The research results obtained by pharmacology professor Bingfan Yan were worrying enough that he immediately reported the results to the FDA, which approved orlistat in 1999.

Liver and kidney damage are serious enough, but the report had another finding that orlistat’s metabolic action reduces the effectiveness of many medications, including life-saving cancer treatments. In fact, the researchers reported that cancer cells multiplied faster under the influence of orlistat. Orlistat also boosts the anti-clotting effects of aspirin, raising the risk of bleeding both internal and external.

Saturday, December 08, 2012

December 7, 2012: NECC Tainted Steroid Medication Update

Our firm filed a Motion to Inspect the NECC facility. The FDA issued an inspection report, and in it there are observations of the New England Compounding Facility. A number of issues will be part of the litigation, including the "Clean Room" where the recalled products were made.  

Here's a virtual clean room, put together by Purdue:

Generally found in hospitals and home health care companies, the rooms are used to prepare drugs, intravenous drips, syringes, chemotherapy treatments and the like, especially those administered directly into the bloodstream—a factor that makes vital the use of a clean room and proper clean-room procedures. Concern over the rise of antibiotic-resistant pathogens has only increased the need for such expertise.

Why this matters in the New England  Compounding Pharmacy litigation: Access, production, and preparation all will be analyzed to determine if this tragedy could have been prevented if the clean room was operated the right way. 

Talk to our law firm if you were harmed by a medication made by NECC. 

Thursday, December 06, 2012

Recall Notification of Life Pulse High-Frequency Ventilator Patient Circuits

Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell’s website,
The product has been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge.  There have been 12 reported failures out of 5,771 Patient Circuits distributed.  There have been no reports of patient injury or death.  However, out of an abundance of caution Bunnell wants clinicians to be aware of the potential that a Patient Circuit failure could result in patient injury or death.
Bunnell is working with the U.S. Food and Drug Administration to resolve this issue.
Bunnell will notify customers via certified mail and will post the recall notification and other important information at

FDA vegetarian meat recall: Veggie Patch – The Ultimate and Falafel

News from the FDA on this recall:

EGGIE PATCH® is voluntarily recalling two products --The Ultimate Meatless Burger and Falafel-- due to a risk of contamination with Listeria monocytogenes.  Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy persons may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths in pregnant women.
The Ultimate Meatless Burger and Falafel, from VEGGIE PATCH, with the specific use-by dates and UPC codes listed below were distributed to a select number of retailers and distributors.
  • 9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, The Ultimate Meatless Burger with a Use-By date, Jan/12/2013; UPC code 6-10129-00211-5 (which can be found on back of package)
  • 9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, Falafel with a Use-By date, Jan/15/2013; UPC code 6-10129-06619-3 (which can be found on back of package)
The Ultimate Meatless Burger potentially affected was available for sale as of November 21, 2012, in the following states; NY, CT, PA, FL, IL, MD, IN, WI, VA, NJ and DE.  Falafel potentially affected, was available for sale as of November 21, 2012, nationwide.
No illnesses have been reported to date.  VEGGIE PATCH discovered this issue as part of its routine testing of its products.
Consumers who purchased any product with the specific use-by dates and UPC codes listed above are asked to dispose of the product. They should email to arrange for a full refund.  The recall affects only these two items. Products that do not contain the specific use-by dates and UPC codes listed are not affected by the recall.  No other VEGGIE PATCH products or other use-by dates of The Ultimate Meatless Burger or Falafel are affected by this recall.  Frozen Veggie Patch products are not affected by this recall.

Monday, December 03, 2012

Do NFL Players use Viagra to Enhance Performance?

NFL  wide receiver Brandon Marshall says he's heard of some NFL players using the drug to improve athletic performance — on the field. One benefit of Viagara and similar drugs would be the enhanced delivery of oxygen to the muscles, which also aids in hastening the body's recovery from workouts. The drug also counteracts impotence, a frequent side-effect of steroid usage.