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At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Natural?« Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.
"The FDA will not tolerate companies marketing unapproved drugs — products that have not proven to be safe or effective — as dietary supplements," said Margaret O’K. Glavin, associate commissioner for regulatory affairs. "The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products."
The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Buy generic ultram Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.
In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.
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. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.
The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products. Consumers and health care professionals can report adverse events to FDA’s MedWatch program at 800-FDA-1088 or online at FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.
The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro, deputy chief, Civil Division, United States Attorney’s Office, District of Puerto Rico.

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A study into teenagers with food allergies will investigate what life is like for them in an attempt to improve their quality of life and curb the number of allergy-related deaths.
Scientists at the University of Portsmouth have created a quality of life questionnaire which asks teenagers what it is like for them to live with a food allergy. They are inviting young people with food allergies to come forward to take part in the study.
A previous UK study which examined all deaths from food-related allergies between 1992-2001 suggested that 35 per cent of deaths occurred in youngsters aged from 10-19.
Children aged 10-14 years accounted for 10 per cent of food allergy deaths and those aged 15-19 accounted for 25 per cent.
Heather Mackenzie, from the University’s School of Health Sciences and Social Work said:
"Although deaths from food allergy are rare, teenagers are overrepresented in these figures. This indicates that they find food allergies the most difficult to deal with."
In order to develop a draft questionnaire she has interviewed youngsters and discovered that their attitudes to food allergies vary and that the severity of the condition doesn’t always dictate the way they feel about it and the way they manage it. She said:
"Some teenagers have relatively mild food hypersensitivity but it has a drastic affect on their quality of life, and vice versa. Teenagers are especially vulnerable because they are learning to take responsibility for their food allergy, which is challenging in itself, whilst also trying to be a normal teenager. Those with serious allergies carry around pre-loaded injection kits containing adrenaline and some see it as a nuisance but it’s vital that they understand that it can save their lives and that thousands of others are in the same boat."
The aim of the new study is to provide doctors and other healthcare professionals with a tool to assess teenagers’ quality of life by finding out how they feel about their allergy. It will help doctors give them advice on how to manage their allergy and sources of further help.
Mackenzie says she wants more volunteers to complete the questionnaire in order to ensure that it accurately reflects teenagers’ concerns. Buy cipro pills She wants to hear from teenagers who would like to help people to understand more about what living with a food allergy is like for them.
The Anaphylaxis Campaign, a national charity for people with potentially life-threatening allergies (www.anaphylaxis.org.uk), will be helping the study by sending questionnaires to some of its teenage members.
David Reading, director of the Anaphylaxis Campaign, said: "Food allergy can occasionally be serious, but we are convinced that teenagers who are affected can learn how to protect themselves. We would hope that this study will lead to a greater understanding of the problem that allergic teenagers face and better medical advice for them."
Young people aged 13-18 who would like to take part can go to www.port.ac.uk/foodallergysurvey or contact Heather Mackenzie on 023 9284 4441 or heather.mackenzie@port.ac.uk. They will be asked to complete a short questionnaire about how having food allergies affects their life and will be entered into a prize draw to win an iPod.
For more information visit the following
link.
Food allergies affect approximately 2.3% of teenagers and approximately 1.4-1.8% of the UK adult population as a whole
The most common allergies are to peanuts and other nuts and they frequently severe but other foods which can be triggers include egg, milk, fish, shellfish, soya, sesame and wheat.
Any allergic reaction, including the most extreme form, anaphylactic shock, occurs because the body’s immune system reacts inappropriately in response to the presence of a substance that it wrongly perceives as a threat.
From 1992 - 2002 the UK the youngest person to die from a fatal reaction to peanut was 13 years old and the median age was 21 years.
6 children aged between 10-14 years died in the years between 1992-2001 in the UK and 15 teenagers aged 15-19 years died (25%).
Symptoms of food related allergies include
- generalised flushing of the skin
- nettle rash (hives) anywhere on the body
- abdominal pain, nausea and vomiting
- swollen lips
- anaphylaxis
- sense of impending doom
- swelling of throat and mouth
- difficulty in swallowing or speaking
- alterations in heart rate
- severe asthma
- sudden feeling of weakness (drop in blood pressure)
- collapse and unconsciousness
University of Portsmouth

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A new study published in the Journal of
Neurology Neurosurgery and Psychiatry finds that Prozac, a
commonly prescribed antidepressant, may be an agent in slowing
down the disease process of the relapsing remitting form of multiple
sclerosis (Buy lasix without prescription MS).
Multiple sclerosis is an autoimmune disease where the immune system
attacks the central nervous system. In the relapsing remitting form,
new symptoms occur in discrete attacks.
A team of researchers led by J P Mostert (Department of Neurology,
University Medical Center Groningen, University of Groningen,
Groningen, The Netherlands) conducted a double-blind,
placebo-controlled, exploratory analysis of 40 patients
with the relapsing
remitting form of MS. For a period of 24 weeks, half of the sample was
treated with 20 mg daily of fluoxetine
(Prozac) while the other half received a placebo. To measure the
activity of MS, detailed magnetic resonance images (MRI) of the
participants’ brains were completed every four weeks. The researchers
focused on areas of neurological inflammation that would indicate
active disease.
Of the 40 initial patients, 19 participants in each group finished the
study. The main finding was that the patients who were treated with
Prozac had fewer new areas of inflammation than those treated with
placebo. The researchers were able to detect the effects just after
eight weeks - the same amount of time that it takes for selective
serotonin reuptake inhibitor
(SSRI) drugs such as Prozac to begin relieving depression.
Specifically, the group given placebo had an average of over five new
areas affected with inflammation compared to just less than two areas
in the Prozac group. Twenty-five percent of scans from Prozac-treated
patients and forty percent of placebo-treated patients depicted new
areas of inflammation. Almost two out of three patients in the Prozac
group had no new inflammation areas during the last 16 weeks of
treatment, whereas only about 25% of patients in the placebo group had
no new areas.
Although this was a small-scale study and a larger sample size is
required to increase the robustness of results, the authors conclude
that, "Results of our exploratory trial are sufficiently encouraging to
justify further studies with fluoxetine in patients with MS. Higher
doses of fluoxetine and combination treatment with immunomodulatory
drugs should be considered."
Effects of fluoxetine on disease activity in relapsing
multiple sclerosis: a double-blind, placebo-controlled, exploratory
study
J P Mostert, F Admiraal-Behloul, J M Hoogduin, J Luyendijk, D J
Heersema, M A van Buchem, J De Keyser
Journal of Neurology
Neurosurgery and Psychiatry. (2008)
doi: 10.1136/jnnp.2007.139345
Click
Here to See Article Online
Written by: Peter M Crosta
View drug information on Prozac Weekly.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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Howard Hughes Medical Institute (HHMI) researchers have found that rare mutations in three genes contribute to blood pressure variation in the general population.
The scientists had previously shown that mutations in the three "salt handling" genes cause several rare diseases that are characterized by low blood pressure. By sequencing DNA samples obtained from 3,125 people who are participating in the Framingham Heart Study, the researchers identified new functional mutations in these three genes that are likely to be carried by an estimated 100 million people worldwide.
The Framingham Heart Study was begun in 1948 in an effort to identify common factors or characteristics that contribute to cardiovascular disease by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of cardiovascular disease or suffered a heart attack or stroke.
"We find that about two percent of the population has mutations in at least one of these three genes - although all of the identified mutations are individually very rare," said senior author Richard P. Lifton, a Howard Hughes Medical Institute researcher at Yale University School of Medicine. "Mutation carriers have reduced blood pressure, with a 60 percent reduction in the risk of hypertension at age 60."
The findings, reported in the April 6, 2008, edition of the journal Nature Genetics, are important because they yield tantalizing new evidence about why some people seem to be less susceptible to developing high blood pressure, a condition that affects a billion people worldwide and contributes significantly to heart and kidney disease, and stroke.
What’s more, by identifying the role played by rare genetic mutations in governing how the kidney regulates salt, the researchers have devised a general approach that may be broadly applicable to uncovering the genetic architecture of common conditions such as hypertension.
"This new study, for the first time, extends the findings from patients with rare Mendelian traits to the general population. The findings suggest that independently rare mutations that alter salt handling by the kidneys collectively account for a substantial fraction of the general population’s variability in disease susceptibility," said Lifton.
Lifton noted that there are probably about 100 million people worldwide who carry the mutations and are thus protected from hypertension. "The mutations we have identified have clinically meaningful effects to individual patients and suggest that independently rare mutations will collectively account for a substantial fraction of the population’s variability in disease susceptibility," he said.
The researchers started by examining variations in three genes known to cause rare recessive diseases characterized by large reductions in blood pressure. The analysis was conducted on "salt handling" genes isolated from people involved in the Framingham Heart Study (FHS), which is directed by Daniel Levy of the National Heart, Lung and Blood Institute. Levy is a co-author of the Nature Genetics report. Co-first authors Weizhen Ji and Jia Ni Foo are at Yale University School of Medicine.
Lifton’s team zeroed in on the three salt-regulating genes — NCCT, NKCC2 and ROMK — which his group had previously linked to rare but serious human diseases, including Gitelman and Bartter syndromes. Both are conditions characterized by inherited low blood pressure caused by recessive mutations, where two defective copies of a gene are at play.
Salt handing is an essential function of the kidneys. Our kidneys process more than three pounds of salt per day, and genetic mutations that raise or lower the ability of the organ to absorb and process salt can manifest themselves in higher or lower blood pressure.
Lifton’s group has searched worldwide for patients with very high or very low blood pressure due to mutations in single genes. Such patients are often identified through family histories of extreme blood pressure. To date, his group has found a score of gene mutations that lower or raise blood pressure, including those that cause the extreme low blood pressure found in patients with Gitelman and Bartter syndromes.
"We used knowledge of the spectrum of mutations that cause Gitelman and Bartter syndromes to sort among the hundreds of sequence changes we observed to identify those that are either known or highly likely to alter the function of the (gene) encoded proteins," Lifton explained.
By sequencing each of the three genes obtained from DNA samples from 3,125 participants in the Framingham Heart Study, and doing additional biochemical, genetic and genomic analysis, the HHMI team found functional mutations in one of the genes in at least 1 of every 64 of the study’s participants sampled.
"The results show that nearly 2 percent of the FHS cohort has a defective copy of one of these three genes," Lifton said. "Unlike patients with Gitelman and Bartter syndromes, these subjects have only one defective copy, not two."
Lifton’s group then tracked the influence of the mutation on blood pressure in FHS subjects aged 40-60, a time of life when hypertension manifests itself and can pose serious health risks.
"We found that these mutation carriers have a 60 percent reduction in their risk of developing hypertension" and have significantly lower blood pressure than those who do not have mutations," Lifton said. The influence of the mutation, he added, approximates effects achieved with drugs used to lower blood pressure.
The practical upshot of the new work, according to Lifton, could be potential new drugs to mimic the effects of the mutation by selectively inhibiting a single gene or several genes.
In addition, the study more broadly underscores the value of genetic analysis — resequencing of genes and genomes to ferret out functional mutations — for understanding individual risk of disease.
"Buy generic cialis A major question about the genetic underpinnings of hypertension and other common diseases has been whether these are accounted for by common or rare DNA variations," said Lifton. "Our study demonstrates the role of rare variation, showing that effects of rare mutations in these three genes cause relatively large effects, with clinically significant effects in individual patients. These findings suggest that much of the variation in common disease risk for hypertension and other diseases will be accounted for by rare (genetic) variants."
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Source: Jim Keeley
Howard Hughes Medical Institute
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The beauty of budding plants and bouquet of aromas are sources of satisfaction for many gardeners. For allergy sufferers, though, gardening can be as much a chore as pursuit of passion.
Pollen from trees, shrub and grasses can cause an onslaught of allergy symptoms, including sneezing, itchy eyes, congestion and in some cases, an asthma attack.
But sensitive people can take a few simple steps to minimize their risk of exposure to bothersome allergens, according to the American Academy of Allergy, Asthma & Immunology (AAAAI).
"Gardening outside during times of high pollen counts puts patients at risk for severe allergic symptoms," said Warren Filley, MD, FAAAAI, an Oklahoma City allergist/immunologist and a long-time horticulturalist who suffers from allergies. "Avoidance measures, as well as the use of medications and allergy immunotherapy, can make the difference between having fun in the garden and being miserable."
An allergist/immunologist can help determine what plant species are causing an allergic reaction and advise on the best times of day or season to work in the garden. For example, pollen levels are typically lower on rainy, cloudy and windless days. Immunotherapy (allergy shots), medications and other treatments can also help reduce symptoms.
People with allergies can also trim irritation by carefully choosing the plants they include in their landscaping or garden.
Certain flowers, trees and grasses are naturally better suited for the gardens of allergic people. They are less likely to produce bothersome pollen and will still add color and variety to the garden.
These include:
- Cacti
- Cherry
- Dahlia
- Daisy
- Geranium
- Iris
- Magnolia
- Rose
- Snapdragon
- Tulip
In general, highly-allergenic plants to avoid include:
- Ash
- Cedar
- Cottonwood
- Oak
- Maple
- Pine
- Saltgrass
- Timothy
The best way to determine which plants will trigger reactions is through skin testing at an allergist/immunologist’s office. An allergist/immunologist can help patients develop strategies to avoid troublesome plants and pollen and can prescribe medication to alleviate symptoms.
Other tips to consider
Whenever working around plants likely to cause an allergic reaction, avoid touching your eyes or face. You may also consider wearing a mask to reduce the amount of pollen spores that you breathe in. Wear gloves and long sleeves and pants to minimize skin contact with allergens. Leave gardening tools and clothing - such as gloves and shoes - outside to avoid bringing allergens indoors. Shower immediately after gardening or doing other yard work.
Consult with an allergist/immunologist
Contact an allergist/immunologist to identify specific causes of allergic reactions or to get information on treatment options and tips to reduce allergen exposure. Buy acomplia without prescription An allergist/immunologist is the best qualified medical professional to manage the prevention, diagnosis and treatment of allergies and asthma. To find an allergist/immunologist near you, visit the AAAAI Web site at www.aaaai.org.
The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease. Established in 1943, the AAAAI has more than 6,500 members in the United States, Canada and 60 other countries.
American Academy of Allergy, Asthma & Immunology
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