An article published in the Archives of Internal Medicine
reports that statins - medications that are usually prescribed to lower
blood cholesterol levels - may also lower blood pressure. Beatrice A.
Golomb, M.D., Ph.D., (University of California, San Diego, La Jolla)
and colleagues noted a modest but significant reduction in blood
pressure for patients taking statins.
Statins are a type of drug that inhibits an enzyme involved in the
synthesis of cholesterol, and thus leads to a decrease in blood
cholesterol levels. Previous research has found that blood pressure may
also be affected by statins, specifically for patients with high blood
pressure (hypertension). It has been hypothesized that statins trigger
compounds that make blood vessels wider, improving their
function.
To test the effect of statins on blood pressure, the researchers
conducted a randomized, double-blind trial with 973 participants who
did now have diabetes or cardiovascular disease. Over a period of six
months between 2000 and 2004, the researchers told 322 participants to
take 20 milligrams of the statin simvastatin, 323 participants to take
40 milligrams of the statin pravastatin, and 328 participants to take
placebo. The statin amounts were taken from usual doses from when they
are prescribed to lower cholesterol. At the beginning of the study, the
researchers took blood pressure measurements of each participant.
Additional measurements were taken after one and six months during the
treatment period, and also two months after ending treatment.
Blood pressure is conventionally reported using two numbers: systolic
(top number) over diastolic (bottom number). The researchers found that
individuals who took the statin had an average decrease of 2.2 mmHg in
systolic blood pressure and an average decrease of 2.4 mmHg in
diastolic pressure. The authors note that, "Blood pressure reductions
ranged from 2.4 to 2.8 milligrams
of mercury for both systolic blood pressure and diastolic blood
pressure with both simvastatin and pravastatin, in those subjects with
full follow-up and without potential for influence by blood pressure
medications (i.e., neither receiving nor meriting blood pressure
medications)."
The authors, however, found that the effect of statins changed over
time. After one month of statin treatment, there was no noticeable
effect on blood pressure. But there was a significant effect after six
months of treatment, and the effect decreased two months after
finishing treatment.
"This study adds to our understanding of the effects of statins,
currently the best-selling prescription drugs in the world," conclude
the researchers. "The reduction in blood pressure seen with statins may
contribute - among other identified factors - to some of the ‘rapid’
cardiovascular benefits of statins, arising too swiftly to be explained
by effects of statins on plaque accumulation."
Reduction in Blood Pressure With Statins
Beatrice A. Golomb, MD, PhD; Joel E. Dimsdale, MD; Halbert L. White,
Buy generic cipro PhD; Janis B. Ritchie, BSN; Michael H. Criqui, MD, MPH
Archives of Internal Medicine (2008). 168[7]:
721 - 727.
Click
Here to View Abstract
Written by: Peter M Crosta
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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The modern workplace is often blamed for increased rates of depression and stress. New research published in the journal Occupational Medicine, shows that resuming work can actually aid recovery and help depressed employees. However, the Society of Occupational Medicine warned that employers need to be sensitive and consider a range of interventions including changing an employees tasks and reducing hours to help people when they return to work. Line managers also play a key role as an early return to work is aided by line managers keeping in touch at least once every two weeks.
The study followed more than 500 people who were unable to work with depression from a variety of industries over the course of a year. A return to employment significantly promoted recovery. Importantly, it was the approach and flexibility of their employers that proved vital.
The study echoes the findings of Dame Carol Black’s Review ‘Working for a healthier tomorrow’ which recognized that for most people work is good both for their long-term health and for their family’s well-being. Buy generic diflucan The review found that ill health was costing the country ??100 billion a year - ??40 billion of which was related to mental health.
"Better access to occupational health services and psychological support are essential if employees with depression and anxiety are to get back to work quickly" said Dr Gordon Parker, President of the Society of Occupational Medicine. "’Employers are often frightened of contacting an employee whose sick note says ‘depression’ for fear of being accused of harassment, but sympathetic contact with the employee and early help through occupational health can identify the most appropriate support. Occupational health services are ideally placed to advise managers and employees on the best return to work plan and should be involved early in the management of the employee’s absence".
In any one year about 1 in every 4 employees in the UK will have a mental health problem, and depression is one of the most common. It is not just distressing for the person involved. It makes them less productive at work and is responsible for high rates of sick-leave, accidents and staff turnover. Work often plays one of the largest roles in shaping people’s identity and if employees are absent for some time due to anxiety or depression, this can add to feelings of a lack of self-worth. This study shows that going back to work is often one of the most important factors in speeding up a return to full health. It provides an opportunity to regain a sense of self-esteem and puts routine and stability back into people’s lives.
A good occupational health team can help senior management develop programmes to educate line managers and the workforce about depression so that the problem is recognised, appropriate early intervention given and employees are helped to return to work. Occupational Health staff will know about the particular stresses and strains of the work environment and have experience of sensitive issues such as workplace confidentiality, job security and the timing of the return to part-time or full-time working. They are also well placed to work closely with family doctors or other specialist health services.
BT’s ‘Positive Mentality’ programme is an example of how a company can be proactive in this area. Their innovative approach supports not only those who have mental health problems but also those staff who are ostensibly well. By encouraging and promoting small changes in lifestyle, significant improvements have been made in how staff cope with stress and the pressures of work and feel about their mental well-being.
Richard Craig, a 54 year old BT employee from Lancashire, suffered from depression that resulted in 6 months off work. On returning to work his hours were reduced for the first two weeks and then increased each week until he was back on full hours. His manager at the time was in contact with him each week either by phone or one to one. He believes that going back to work and the attitude of his employer was crucial to his recovery.
"Whilst I was ill my manager kept coming to see me and was really supportive. When it was time to go back to work my Occupational Health doctor organised a phased return so that I started back part time. " said Mr Craig "Going back to work gave me a structure and took my mind off things"
Depression and anxiety are now the most common reasons for people starting to claim long term sickness benefits. By investing in occupational health services, senior management teams can play a key role in helping people like Richard Craig return to work. This will improve the overall performance of the organisation and of individual employees and reduce the costs of sickness absence.
1. The Society of Occupational Medicine is the largest UK organisation for all doctors with an interest in Occupational medicine.
2. Occupational Health Doctors:
- Help prevent work-related ill health
- Advise on fitness for work
- Advise on appropriate adjustments in the workplace to help people stay in work
- Provide rehabilitation to help people return to work, and
- Identify and advise on what people CAN do, so that alternative suitable work for people with health problems can be found
- Promote healthy lifestyles and health in the workplace
- Advise employers on appropriate policies to maintain a safe workplace
Occupational Medicine is the journal of the Society of Occupational Medicine. It publishes practical, original research of interest to practising occupational health professionals throughout the world
Society of Occupational Medicine
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Pharmacopeia
(Nasdaq: PCOP), an innovator in the discovery and development of novel
small molecule therapeutics, announced that results from the
company’s Phase 2a clinical trial evaluating PS433540, its first-in-class
Dual Acting Receptor Antagonist (DARA), will be presented as a
late-breaking clinical trial at the American Society of Hypertension (ASH)
Twenty-Third Annual Scientific Meeting and Exposition in New Orleans, May
14-17, 2008.
PS433540 is being developed as a potential treatment for both
hypertension and diabetic nephropathy and is the first and only blood
pressure product candidate in development that possesses two validated
mechanisms of action in a single compound.
Joel Neutel, MD, lead investigator and Director of Research, Orange
County Research Center, Tustin, Calif., will present results of the Phase
2a clinical trial. In addition to the late-breaker, Pharmacopeia will also
present data from its Phase 1 Multiple Ascending Dose (MAD) Study of
PS433540.
Late-breaker presentation:
– "A Double Blind, Placebo Controlled Study to Evaluate the Safety and
Efficacy of a Novel New Dual Acting Receptor Antagonist (DARA
Compound) in Human Subjects with Hypertension"
– Friday, May 16, 2008, 5:38 - 5:55 p.m. CDT (6:38 - 6:55 p.m. EDT)
– New Orleans Marriott, Acadia Ballroom, 3rd Floor
Poster presentation:
– "PS433540 a Novel Dual Acting Receptor Antagonist Dose Dependently
Increases Plasma Renin Activity in Healthy Volunteers"
– Abstract # P-14
– Wednesday, May 14, 2008, Posters on Display: 3:00 - 7:00 p.m. CDT
(4:00 - 8:00 p.m. EDT), Poster Discussion: 5:15 - 6:15 p.m. CDT
(6:15 - 7:15 p.m. EDT)
– New Orleans Marriott, Le Galerie Ballroom, 2nd Floor
About Pharmacopeia
Pharmacopeia is a clinical development stage biopharmaceutical company
dedicated to discovering and developing novel small molecule therapeutics
to address significant medical needs. The company has a broad portfolio of
clinical and preclinical candidates under development internally or by
partners including eight clinical compounds in Phase 2 or Phase 1
development addressing multiple indications including hypertension,
diabetic nephropathy, muscle wasting, inflammation and respiratory disease.
The company is leveraging its fully integrated drug discovery platform to
sustain the growth of its development pipeline. Pharmacopeia has
established strategic alliances with major pharmaceutical and biotechnology
companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more
information please visit the company’s website at

This press release, and oral statements made with respect to
information contained in this press release, constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform
Buy lasix without prescription Act of 1995. Such forward-looking statements include those which express
plan, anticipation, intent, goal, contingency or future development and/or
otherwise are not statements of historical fact. These statements are based
upon management’s current expectations and are subject to risks and
uncertainties, known and unknown, which could cause actual results and
developments to differ materially from those expressed or implied in such
statements. These forward-looking statements include, but are not limited
to, statements about the successful implementation of Pharmacopeia’s
strategic plans, Pharmacopeia’s plans to develop PS433540, a product
candidate from its DARA program, Pharmacopeia’s Phase 2 and Phase 1
clinical studies with respect to PS433540, including timing and expected
outcomes of such studies, Pharmacopeia’s plans to develop PS178990, a
product candidate from its SARM program, Pharmacopeia’s Phase 1 clinical
studies with respect to PS178990, including timing and expected outcomes of
such studies, Pharmacopeia’s plans to develop PS031291, a product candidate
from its chemokine receptor CCR1 program, Pharmacopeia’s estimates of the
market opportunities for its product candidates, including PS433540,
PS178990 and PS031291, Pharmacopeia’s ability to raise additional capital,
Pharmacopeia’s anticipated operating results, financial condition,
liquidity and capital resources, Pharmacopeia’s ability to successfully
perform under its collaborations with Bristol-Myers Squibb, Cephalon,
GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia’s ability to build
its pipeline of novel drug candidates through its own internally-funded
drug discovery programs, third party collaborations and in-licensing,
Pharmacopeia’s expectations concerning the development priorities of its
collaborators, their ability to successfully develop compounds and its
receipt of milestones and royalties from the collaborations, Pharmacopeia’s
expectations concerning the legal protections afforded by U.S. and
international patent law, Pharmacopeia’s ability to pursue the development
of new compounds and other business matters without infringing the patent
rights of others, additional competition, and changes in economic
conditions.
Further information about these and other relevant risks and
uncertainties may be found in Pharmacopeia’s Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia
urges you to carefully review and consider the disclosures found in its
filings which are available in the SEC EDGAR database at
and from Pharmacopeia at All forward-looking
statements in this press release and oral statements made with respect to
information contained in this press release are qualified entirely by the
cautionary statements included in this press release and such filings.
These risks and uncertainties could cause actual results to differ
materially from results expressed or implied by such forward-looking
statements. These forward-looking statements speak only as of the date of
this press release. Pharmacopeia undertakes no obligation to (and expressly
disclaims any such obligation to) publicly update or revise the statements
made herein or the risk factors that may relate thereto whether as a result
of new information, future events, or otherwise.
Pharmacopeia

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The arrival of summer brings with it an alarming increase of honey bees, wasps, yellow jackets and hornets, especially dreadful for those who experience severe allergic reactions to insect venom.
Many who have reactions like hives, breathing difficulty, coughing or a drop in blood pressure are unaware that Epipens, self-injected epinephrine, are no longer the only way to treat insect venom allergies. Preventative measures, like allergy shots, show good results and reduce the chance for subsequent reactions to a very small percent.
Buy lasix pills Raymond Slavin, M.D., an allergy expert and professor of internal medicine at Saint Louis University School of Medicine division of allergy and clinical immunology, has been running clinics to test people for venom allergies since the testing and treatment first became available in the 1970’s. Slavin is available to discuss severe reactions to insect venom, ways to avoid stings and treatment options.
Saint Louis University Medical Center
St. Louis, MO 63103
United States

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Moving house or the separation of parents can significantly increase the risk of children developing allergies later on. These are the results from a long-term study correlating life-style, immune system development and allergies, led by the Helmholtz Center for Environmental Research in Leipzig (UFZ), the Helmholtz Zentrum Munchen and the "Institut f??r Umweltmedizinische Forschung" (IUF) in Duesseldorf. The researchers had examined blood samples taken from 234 six-year old children and discovered increased blood concentrations of the stress-related peptide VIP (vasoactive intestinal polypeptide) in connection with moving house or the separation of parents. The neuropeptide VIP could take on a mediator role between stress events in life and the regulation of immune responses, researchers write in the scientific journal Pediatric Allergy and Immunology. The fact that stress events can have an influence on the development of allergies has been known for a while. The mechanisms behind this however remained unexplained for a long time. In the study that has now been published, stress events were investigated for the first time during early childhood within a large epidemiological study using immune and stress markers.
Stress events during childhood are increasingly suspected of playing a role in the later development of asthma, allergic skin disorders, or allergic sensitisations. Dramatic life events like the death of a family member, serious illnesses of a family member or the separation of parents, but also harmless events like for example moving house are suspected of increasing the risk of allergies for the children affected. The immune system obviously plays a mediator role between stress on the one hand and allergies on the other. Since these mechanisms had hardly been understood before, researchers attempted to identify stress-related factors showing an influence on the immune system, in the context of an epidemiological study (LISA). At the same time as the blood tests, researchers together with colleagues from the Institute for Social Medicine at the University of L??beck also analysed the most diverse social factors in the children’s environment, in order to find out which factors are causing stress-related regulation deficiencies of the immune system. With children, whose parents had separated over the last year, researchers found increased blood concentrations of the neuropeptide VIP (vasoactive intestinal polypeptide) as well as an increased concentration of immune markers, which are related to the occurrence of allergic reactions, like for example the cytokine IL-4. By comparison, serious diseases or the death of close relatives led to no remarkable changes. Likewise, the unemployment of parents was not associated with increased concentrations of the stress-related peptides in the children’s blood. As tragic as these events are, they are obviously however of less significance for the stress reactions of children than for example a separation or the divorce of parents, UFZ researchers have concluded. As was already shown in an earlier publication from the same study, increased concentrations of the stress peptide VIP can also be proven in the blood of children after moving house (similar to the separation of parents). Preceding investigations in LISA showed that there is a relationship between an increased concentration of the neuropeptide VIP and allergic sensitisations among six-year old children. Even if the results were to be interpreted carefully, because of the comparatively small number of children affected, they nevertheless provide valuable indications as to what exactly happens to the body through stress.
generic clomid online buy The investigations are based on data from 6-year old children from the LISA study. LISA stands for "Lifestyle - Immune System - Allergy" and investigates the influences of life-styles on the immune system development in early childhood and the emergence of allergies. In addition to the Helmholtz Center for Environmental Research in Leipzig (UFZ), the Helmholtz Zentrum M??nchen, the German Research Center for Environmental Health, and the "Institut f??r Umweltmedizinische Forschung" (IUF) in Duesseldorf, other universities and clinics are also participating partners, including the Municipal Hospital "St. Georg" in Leipzig. For the LISA study over 3000 newborn children in the cities of Munich, Leipzig, Wesel and Bad Honnef were recruited between the end of 1997 and the beginning of 1999. Parents were repeatedly asked about various lifestyle-reloated factors and disease outcomes. Furthermore, blood tests were carried out at different times. At the age of six a total of 565 children were examined in Leipzig, and for 234 participants, blood analyses regarding stress and immune parameters were carried out. Over the course of the 6-year study nearly one third of the families living in Leipzig were affected by unemployment. For approximately half of all families, severe illnesses were experienced by close family members. By comparison, cases of death among family members or the separation of parents only affected every sixth or tenth child.
HELMHOLTZ CENTRE FOR ENVIRONMENTAL RESEARCH - UFZ
Permoserstra??e 15
D-04318 Leipzig

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Men’s Health News
Men who develop diabetes in mid-life appear to significantly increase their risk of developing Alzheimer’s disease, according to a long-term study published in the April 9, 2008, online issue of Neurology, the medical journal of the American Academy of Neurology.
"Our results have important public health implications given the increasing numbers of people developing diabetes and the need for more powerful interventions," said study author Elina R?nnemaa, MD, with Uppsala University in Uppsala, Sweden.
The study involved 2,269 men in Sweden who underwent glucose testing at age 50 to test for diabetes, which is caused by abnormal insulin levels. During an average follow up of 32 years, 102 participants were diagnosed with Alzheimer’s disease, 57 with vascular dementia and 235 with other types of dementia or cognitive impairment.
The study found that the men with low insulin secretion capacity at age 50 were nearly one-and-a-half times more likely to develop Alzheimer’s disease than people without insulin problems. The risk remained significant regardless of blood pressure, cholesterol, body mass index and education.
"Our results suggest a link between insulin problems and the origins of Alzheimer’s disease and emphasize the importance of insulin in normal brain function," said R?nnemaa. "It’s possible that insulin problems damage blood vessels in the brain, which leads to memory problems and Alzheimer’s disease, but more research is needed to identify the exact mechanisms."
Buy generic cialis The study also found the association between diabetes and risk of Alzheimer’s disease was strongest in people who did not have the APOE4 gene, which is known to increase the risk of Alzheimer’s disease. R?nnemaa says this shows that insulin problems are an important risk factor for Alzheimer’s disease when the high risk gene is missing.

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Lowering the blood pressure of elderly patients could cut their total mortality by a fifth and their rate of cardiovascular events by a third, according to a new study presented at the American College of Cardiology in Chicago and published simultaneously in the New England Journal of Medicine.
The 3,845 patient Hypertension in the Very Elderly Trial (HYVET), which is coordinated by scientists from Imperial College London, is the largest ever clinical trial to look at the effects of lowering blood pressure solely in those aged 80 and over. Buy propecia without prescription Patients were given either a placebo or the diuretic indapamide slow release (SR) 1.5mg, with the addition of the ACE inhibitor perindopril in tablet form once a day.
The research shows that the benefits of treatment include a 21% (p=0.02) reduction in total mortality rate, a 39% (p=0.05) reduction in stroke mortality rate, a 64% (pgeneric levitra online buy | Buy acomplia without prescription | Buy diflucan pills

Cook Medical , announced the launch of www.MensHealthPD.com, an informational microsite dedicated to educating physicians, men and their partners about the symptoms, treatment options and latest research on Peyronie’s disease, a common form of erectile dysfunction thought to affect more than 80, 000 men in the UK, with one study suggesting 1% of the male population may suffer. MensHealthPD.com is designed to provide the latest information on the painful ailment and also offers medical professionals, patients and their partners public and physician forums for discussing the disease, posting questions and sharing personal experiences about the condition.
For many men and their partners, erectile dysfunctions, such as Peyronie’s disease, are embarrassing and uncomfortable to discuss. It is also often difficult to find a centralised repository on the web with the helpful information needed to obtain answers on these conditions. MensHealthPD.com is changing all this by offering these individuals a one-stop, discreet Peyronie’s resource armed with the following assets:
- Video answers to the most commonly asked questions about Peyronie’s disease provided by some the world’s leading Peyronie’s doctor experts.
- A Q&A forum where patients, partners and doctors can discuss available Peyronie’s treatments, exchange ideas on coping with the disease and more.
- Details of the signs, symptoms and progression of Peyronie’s disease.
- A helpful list of questions to prepare a man afflicted with Peyronie’s for his first doctor’s visit
Many men living with Peyronie’s disease go untreated because so few GPs understand the disease. In fact, a recent study showed that over half of primary care physicians were unsure any effective treatments for the disease existed. Therefore, many men never get referred to a urologist who may be able to treat the condition.
Buy diflucan pills MensHealthPD.com will serve as a single source where GPs, urologists and other physicians from around the world can access the latest peer-reviewed research on Peyronie’s treatment options as well as other relevant published scientific data. The following resources are available on the microsite to educate these doctors on the wide array of treatment options available for Peyronie’s sufferers:
- A summary of current surgical and non-surgical treatment options with links to the most current published research.
- The latest peer-reviewed research on Peyronie’s disease posted in the MEDLINE database of citations and abstracts and indexed through PubMed, offered by the US National Library of Medicine and the National Institutes of Health (NIH).
- A secure, physicians-only Q&A forum where doctors can share best practices and increase their collective knowledge with their colleagues.
Raj Persad, a Consultant Urologist at United Bristol Healthcare NHS explains: "This is a distressing disease with huge potential psychosexual impact. In an area such as this where treatment options for different stages of the disease are limited and often confusing for patients we need to share as much information as possible about new management options. This website will benefit both clinicians and patients alike in enabling the sharing of experience and information which could be of benefit to all’
About Peyronie’s Disease
Peyronie’s disease, also known as penile curvature, is estimated to affect nearly four out of every 100 males between the ages 45 and 65[3]. The disease is linked to erectile dysfunction in 20 to 40 percent of the sufferers and is characterised by the formation of a plaque or hardened scar tissue beneath the skin of a man’s penis. The scarring is non-cancerous and may lead to a painful erection and curvature of the penis during erection.

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Biovail Corporation (NYSE: BVF) (TSX: BVF) announced that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin™ (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide developed by Biovail for the treatment of depression in adults.
Buy zithromax without prescription Aplenzin™ is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.
Biovail remains in active partnership discussions for the commercialization rights for Aplenzin™ in the United States.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies.
Biovail Corporation
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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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