IRVINE, Calif., Feb. 11, 2012 (GLOBE NEWSWIRE) -- Regeneca, Inc. (Pink Sheets: RGNA) announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.
Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.
RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. The Company learned today that there was an error on this test and has thus made the decision to issue a voluntary nationwide recall on this lot of RegenArouse. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.
Regeneca, Inc. advises any customers in possession of the RegenArouse product matching the lot number above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: http://www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
CONTACT: Customer Service
(800) 690-6958
Source: Regeneca, Inc.
Type of helmet lining appears to have no significant effect
SAN FRANCISCO, Feb. 11, 2012 /PRNewswire-USNewswire/ -- Concussions and the issues that can occur following one, continue to be a serious problem for football players. However, one simple game strategy: proper helmet fit, may be one of the easiest game winners for prevention, say researchers presenting their study at the American Orthopaedic Society for Sports Medicine's Specialty Day in San Francisco.
"Athletes wearing properly fitted helmets, as reported by team certified athletic trainers, were 82% less likely to experience loss of consciousness (LOC) with a concussion. Helmet age and condition, (new vs. reconditioned) were not significant predictors of amnesia or LOC," said one of the paper's authors, Joseph Torg, M.D. of Temple University in Philadelphia, PA.
Researchers looked at reports from 1,398 concussion events collected by the National High School Sports-Related Injury Surveillance System using High School RIOTM. They used loss of consciousness (LOC) and amnesia as end points to determine concussion severity. Out of those studied, 44 individuals experienced LOC and 267 experienced some form of amnesia. Odds ratios for LOC were calculated based on helmet fit, inner helmet padding systems, athlete age and helmet condition (new vs. reconditioned.)
There is no definitive data that advanced football helmet technology and design is more protective against concussion or intracranial hemorrhage. In fact, current data indicates that helmet fit and air bladder lining may be associated with both concussion and intracranial hemorrhage.
"As we look at preventing concussions and minimizing risk, it is important to realize that it is the responsibility of the athletic director and head football coach to have policies that: Insure that each player has a properly fitted helmet and that a responsible adult supervises and oversees proper helmet air bladder inflation on a weekly basis," said Torg.
The American Orthopaedic Society for Sports Medicine (AOSSM) is a world leader in sports medicine education, research, communication and fellowship, and includes national and international orthopaedic sports medicine leaders. The Society works closely with many other sports medicine specialists, including athletic trainers, physical therapists, family physicians, and others to improve the identification, prevention, treatment, and rehabilitation of sports injuries. AOSSM is also a founding partner of the STOP Sports Injuries campaign to prevent overuse and traumatic injuries in kids. For more information on AOSSM or the STOP Sports Injuries campaign, visit www.sportsmed.org or www.stopsportsinjuries.org
Contact: AOSSM Director of Communications, Lisa Weisenberger, at 847/655-8647 or email lisa@aossm.org
SOURCE American Orthopaedic Society for Sports Medicine
WASHINGTON, Feb. 11, 2012 /PRNewswire-USNewswire/ -- Following is the daily "Profile America" feature from the U.S. Census Bureau:
(Logo: http://photos.prnewswire.com/prnh/20110428/DC91889LOGO)
SATURDAY, FEBRUARY 11: PENNIES
Profile America — Saturday, February 11th. Today's the day to walk around the house and take stock of all the places you've got pennies stashed away — coffee cans, sugar bowls, candy dishes — or loose in a drawer. The reason to find them is because tomorrow is Lost Penny Day — the same day as the birthday of Abraham Lincoln, whose likeness is on the copper penny. The idea is to bundle up all those pennies and donate them to a homeless shelter, the local humane society, or any local charitable organization. And then, human nature being what it is, the pennies can start building up again. Americans are known as being generous, and we each report giving more than $4,300 a year to charity. Profile America is produced by the U.S. Census Bureau: Measuring America—People, Places, and Our Economy.
Sources: Chase's Calendar of Events 2005, p. 130Statistical Abstract of the United States 2012, t. 584
Profile America is produced by the Public Information Office of the U.S. Census Bureau. These daily features are available as produced segments, ready to air, on a monthly CD or on the Internet at http://www.census.gov (look for "Multimedia Gallery" by the "Newsroom" button).
SOURCE U.S. Census Bureau
SAN FRANCISCO, Feb. 11, 2012 /PRNewswire-USNewswire/ -- Elbow position alone appeared to not affect injury rates and performance in college-level, male pitchers say researchers presenting at the American Orthopaedic Society for Sports Medicine's Specialty Day in San Francisco, CA.
"The elbow's position in relation to an injury and enhanced performance in baseball pitchers is highly dependent upon the trunk's position," said lead researcher, Carl W. Nissen, MD of Elite Sports Medicine and Connecticut Children's Medical Center in Farmington, CT. "Our research showed that the pitching motion is complex and a direct relationship between true elbow position and how much stress is placed on a joint does not appear to exist."
The researchers studied 55 collegiate-level, male pitchers who pitched a fastball towards a target 60'6" away. Kinematic data was collected using a Vicon 512 motion capture system, and kinetic data was calculated using custom Matlab programming based on inverse dynamic techniques.
Visual elbow drag had a positive association with ball velocity (p=0.046). Regression analysis showed that for every 10cm of visual elbow drag, ball velocity was decreased by 1.3m/s.
"The results of this study suggest that an improperly positioned elbow (visual or true) is not a factor in increasing injury rates as neither elbow drop nor drag correlated with elbow stress. Elbow drag, however, did correlate with decreased ball velocity demonstrating that elbow position is important for pitcher performance," said Nissen.
The American Orthopaedic Society for Sports Medicine (AOSSM) is a world leader in sports medicine education, research, communication and fellowship, and includes national and international orthopaedic sports medicine leaders. The Society works closely with many other sports medicine specialists, including athletic trainers, physical therapists, family physicians, and others to improve the identification, prevention, treatment, and rehabilitation of sports injuries. AOSSM is also a founding partner of the STOP Sports Injuries campaign to prevent overuse and traumatic injuries in kids. For more information on AOSSM or the STOP Sports Injuries campaign, visit www.sportsmed.org or www.stopsportsinjuries.org.
Contact: AOSSM Director of Communications, Lisa Weisenberger, at 847/655-8647 or e-mail lisa@aossm.org
SOURCE American Orthopaedic Society for Sports Medicine
Increased age and weight also factor
SAN FRANCISCO, Feb. 11, 2012 /PRNewswire-USNewswire/ -- Kids treated more than 150 days after an Anterior Cruciate Ligament (ACL) injury have higher rates of other knee injuries, including medial meniscal tears, say researchers presenting at the American Orthopaedic Society for Sports Medicine's (AOSSM) Specialty Day in San Francisco, CA.
"In our research, children who had delayed treatment of an ACL injury more than 150 days, tended to have an increased chance of also having a medial meniscus or chondral injury in their knee. These additional injuries may increase recovery time, inhibit return to play, and worsen long term functional outcomes of the knee," said lead researcher, Guillaume D. Dumont, MD of the University of Texas Southwestern Medical Center in Dallas, Texas. "This finding may also be relevant when counseling patients and their families regarding timing for injury treatment."
The researchers analyzed records from 370 patients who underwent ACL reconstruction between January 2005 and January 2011 at Children's Medical Center of Dallas. 200 patients were more than 15 years old and 170 patients were less than 15 years old. There were 208 male patients and 162 female patients involved in the study. Patients were injured in a variety of athletic activities: football (29.7%), basketball (20.2%), soccer (17.6%), cheerleading/gymnastics (4.3%), and other (28.1%).
"Weight also appeared to be a factor associated with the rate of meniscal tears found at the time of surgery," comments senior author, Philip Wilson, MD. "Our data demonstrates patient weight over 143 lbs (65 kg) to be associated with an increased rate of medial and lateral meniscal tears at the time of surgery. With recent significant increases in child and adolescent obesity rates, this finding may have significant public health implications."
The study also demonstrated a relationship of age with children more than 15 years old having a higher rate of medial femoral chondral injury. Neither gender nor sport played during injury was found to be associated with an increased rate of injury in the study.
The American Orthopaedic Society for Sports Medicine (AOSSM) is a world leader in sports medicine education, research, communication and fellowship, and includes national and international orthopaedic sports medicine leaders. The Society works closely with many other sports medicine specialists, including athletic trainers, physical therapists, family physicians, and others to improve the identification, prevention, treatment, and rehabilitation of sports injuries. AOSSM is also a founding partner of the STOP Sports Injuries campaign to prevent overuse and traumatic injuries in kids. For more information on AOSSM or the STOP Sports Injuries campaign, visit www.sportsmed.org or www.stopsportsinjuries.org.
Contact: AOSSM Director of Communications, Lisa Weisenberger, at 847/655-8647 or e-mail lisa@aossm.org
SOURCE American Orthopaedic Society for Sports Medicine
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