In The News

FDA Warns Consumers Not to Use ”Dietary Supplements” Marketed for Erectile Dysfunction

Removing Thimerosal From Vaccines Did Not Reduce Autism Cases in California

Testosterone Supplementation in Older Men Appears to Have Limited Benefit

Massage May Help Ease Pain and Anxiety After Surgery

FDA Warns Consumers Not to Use ”Dietary Supplements” Marketed for Erectile Dysfunction

The US Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products. These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement.

Although labeled as dietary supplements, they do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products, which are packaged and distributed by Shangai Distributor, Inc, of Coamo, Puerto Rico, are therefore illegal drugs because they lack FDA approval.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions, and because they may have been advised against taking ED drugs, these patients may seek out products marketed as “all natural” or not containing the active ingredients in approved, prescribed ED drugs. The manufacturing source of the active ingredients in these products is unknown, and therefore the safety, efficacy, and purity of these ingredients cannot be validated.

Chemical testing of the products by the FDA revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

The FDA advises consumers who have used any of these products to discontinue use and consult their healthcare providers if they have experienced any adverse events that they feel are related to their use. Consumers and healthcare professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Removing Thimerosal From Vaccines Did Not Reduce Autism Cases in California

Autism cases continued to increase in California after the mercury-containing preservative thimerosal was eliminated from most childhood vaccines, according to a report in the January issue of Archives of General Psychiatry, suggesting that exposure to thimerosal is not a primary cause of autism.

Diagnosed cases of autism and related conditions, known collectively as autism spectrum disorders, have increased in recent years. According to the study’s authors, increased exposure to thimerosal, a preservative that contains 49.6% ethylmercury by weight, has been postulated to have contributed to the increase in reported cases of autism spectrum disorders. Thimerosal was eliminated from most vaccines by 2001.

Robert Schechter, MD, MSc, and Judith K. Grether, PhD, of the California Department of Public Health, Richmond, studied the prevalence of children with autism in California from 1995 through March 2007 using data provided by the California Department of Developmental Services, which administers a statewide system of centers that serve individuals with autism and other developmental problems.

Their findings were as follows: Per 1 000 children born in 1993, 0.3 had autism at age 3, compared with 1.3 per 1 000 births in 2003. The highest estimated prevalence—4.5 cases per 1 000 births—was reached in 2006 for children born in 2000. “Although insufficient time has passed to calculate the prevalence of autism for children 6 years and older born after 2000, the prevalence at ages 3 to 5 years has increased monotonically for each birth year since 1999, during which period exposure to thimerosal has been reduced,” the authors said.

Testosterone Supplementation in Older Men Appears to Have Limited Benefit

Older men with low testosterone levels who received testosterone supplementation increased lean body mass and decreased body fat but were no stronger and had no improvement in mobility or cognition compared with men who did not use the supplement, according to a study in the January 2 issue of JAMA.

Marielle H. Emmelot-Vonk, MD, of University Medical Center Utrecht, the Netherlands, and colleagues conducted a randomized, placebo-controlled study to assess the effects of testosterone supplementation on functional mobility, cognition, bone mineral density, body composition, lipids, quality of life, and safety parameters in older men with testosterone levels <13.7 nmol/L (less than the average level in this age group) during a 6-month period. The trial, conducted from January 2004 to April 2005, included 207 men between the ages of 60 and 80 years. Participants were randomly assigned to receive 80 mg of testosterone undecanoate or a matching placebo twice daily for 6 months.

The researchers found that during the study, lean body mass increased and fat mass decreased in the testosterone group compared with the placebo group, but these factors were not accompanied by an increase of functional mobility or muscle strength. Cognitive function and bone mineral density did not change. Insulin sensitivity improved, but high-density lipoprotein cholesterol (the “good” cholesterol) decreased. By the end of the study, 47.8% in the testosterone group vs 35.5% in the placebo group had the metabolic syndrome (a strong risk factor for cardiovascular disease and type 2 diabetes, a group of several metabolic components in one individual including obesity and dyslipidemia). This difference was not statistically significant. Quality-of-life measures did not differ aside from hormone-related quality of life in the testosterone group. Adverse events were not significantly different in the 2 groups. Testosterone supplementation was associated with an increase in the concentrations of blood creatinine, a measure of kidney function, and hemoglobin and hematocrit, 2 red blood cell measures. No negative effects on prostate safety were detected (some reports have suggested that testosterone therapy could increase the risk of development or progression of prostate disease or cancer).

Massage May Help Ease Pain and Anxiety After Surgery

A 20-minute evening back massage may help relieve pain and reduce anxiety following major surgery when given in addition to pain medications, according to a report in the December issue of Archives of Surgery.

Many patients still experience pain after major surgery despite the availability of pain-relieving medications. Pain may be under-treated because patients fear becoming dependent on medications, are concerned about side effects, believe that they should endure pain without complaining, or worry about bothering nurses. Physicians and nurses may administer ineffective doses of pain relievers because of personal biases, cultural attitudes, or a lack of knowledge.

Allison R. Mitchinson, MPH, NCTMB, of the Department of Veterans Affairs, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, and colleagues conducted a randomized controlled trial involving 605 veterans (average age 64) undergoing major surgery (chest or abdominal) between 2003 and 2005. Patients were randomly assigned to 1 of 3 groups for the 5 days following surgery: 203 received routine care; 200 received a daily 20-minute back massage; and 202 received 20 minutes of individual attention each day from a massage therapist but no massage—the purpose of which was to study the effect of emotional support independent of massage. Patients were asked to rate the intensity and unpleasantness of their pain, plus their level of anxiety, on scales of 1 to 10 daily.

The study found that patients in the massage group, compared with the control group, experienced short-term (preintervention vs postintervention) decreases in pain intensity, pain unpleasantness, and anxiety. Additionally, patients in the massage group experienced a faster decrease in pain intensity and unpleasantness during the first 4 postoperative days compared with the control group. There were no differences in long-term anxiety, length of hospital stay, or the amount of pain-relieving medications used among the 3 groups.

The authors theorize that massage may ameliorate suffering by helping to relieve the anxiety that synergizes with pain to create distress. It could also generate mood-boosting endorphins or create a competing sensation that blocks pain.