HS Newsletter Issue #2

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Move from payment in Australian $ to US $ on 26th August 2009
New measuring devices
New Information Booklets
Advance notice: New product NATRAGEN estradiol cream 0.2%
Lawley Pharmaceuticals on display in December 2009 in Las Vegas

Other news

Testosterone and Men's health

FDA forces labelling changes to AndroGel and Testim- 7 May 2009

Reference: Medscape

Medscape offers specialists, primary care physicians, and other health professionals the Web's most robust and integrated medical information and educational tools. It is FREE to access.

May 7, 2009 — The US Food and Drug Administration (FDA) held a press conference today to announce a change in the labeling of the testosterone gel products AndroGel 1% (Solvay Pharmaceuticals) and Testim 1% (Auxilium Pharmaceuticals). The label is now required to include a boxed warning about the dangers of secondary exposure to children.

The decision to add the boxed warning was a result of reports of adverse events in 8 children (as of December 1, 2008) who had been in close contact with users of the products.

The children, ranging in age from 9 months to 5 years, developed "inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior," the FDA release states.

"In most cases, the signs and symptoms regressed when the child no longer was exposed to the product. However, in a few cases, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age," Diane Murphy, MD, from the Office of Pediatric Therapeutics, Office of the Commissioner, FDA, told Medscape Diabetes & Endocrinology.

"In some cases, children had to undergo invasive diagnostic procedures and, in at least one case, a child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms," FDA officials reported.

Mark Hirsch, MD, medical team leader of urology in the Division of Reproductive and Urologic Products, Center for Drug Evaluation and Research, FDA, said that "the case review has been incomplete, but some of these children were less than a year old...[and] they had rather high levels of testosterone," which were likely a result of direct skin-to-skin contact with areas to which the gel had been applied.

The labeling states that treated areas should be covered with clothing and that hands should be thoroughly washed with soap and water after application. The new warning will highlight these directions.

The boxed warning will include the following:

Adults who use testosterone gels should wash their hands with soap and warm water after every application;
Adults should cover the application site with clothing once the gel has dried;
Adults should wash the application site thoroughly with soap and warm water before any situation where skin-to-skin contact with another person is anticipated;
Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
Adults should note that use of any similar, but unapproved, products from the marketplace — including from the Internet — that can result in the same serious adverse effects should be avoided.
Any adverse events associated with testosterone gels should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Editors Note: Apart from the washing of hands after application this problem is not associated with Andromen Forte if applied scrotally.

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Friday August 28, 2009

HORMONE SOLUTIONS NEWSLETTER ISSUE # 2

WELCOME

Dear Hormone Solutions Customer

Welcome to the second issue of the Hormone Solutions newsletter. As our valued customer we believe in informing you of the latest medical research in hormone treatments and about what's happening at Hormone Solutions. Should you wish to Unsubscribe please do so by clicking the Unsubscribe link on the left hand side of this Newsletter. Since Issue #1 in March 2009 there has been some interesting hormone research news published in the medical journals and exciting product improvements about to happen with the appearance of Lawley Pharmaceuticals product range. The continuous flow of positive feedback we have been receiving from patients reinforces to all the staff at Hormone Solutions that the quality of the product and high standard of customer care truly makes a difference to the lives of the people we service. Working as a pharmacist at the coalface of retail pharmacy for 16 years and listening to my patients, has taught me about the value of responding to customer needs and it was the dissatisfaction with the "hormone options" message that came ringing through loud and clear over many years. From humble beginnings in 1995 Lawley Pharmaceuticals and Hormone Solutions has steadily grown largely due to meeting patients and prescribers needs with products that are bio-identical to naturally produced human hormones and in a dose form that is easy to use, effective and is affordable. I am continuously amazed at the price demanded for pharmaceuticals in the USA and am sympathetic to the hip-pocket of the US pharmaceutical consumer. Lawley Pharmaceuticals and Hormone Solutions is proud that we can offer an international pharmaceutical grade product to physicians and patients at a fraction of the cost of big Pharma. Your correspondence reinforces this belief for which I thank you.

Please enjoy reading this newsletter and never hesitate to contact us with any suggestions, concerns or queries that you may have.

Yours sincerely

Michael Buckley
CEO and Principal Pharmacist

Move from payment in Australian $ to US $ on 26th August 2009

In Newsletter Issue #1 we flagged the 6 March 2009 as the date for the change from charging in Australian dollars to US dollars. Unbeknown to us at the time the US banking system was making radical policy shifts in response to the global financial crisis, especially with respect to foreign companies accessing US on-line banking gateways. As a result a major US bank reversed prior approvals at the last moment and we were unable to implement the change to US dollars on the date previously stated. After many months of negotiation we have made the change to $US as of the 26th of this month. This change will remove the confusion that has existed for some people when reviewing credit card statements and avoids the problem of fluctuations in international exchange rates. It will also avoid the charges some credit card companies levy due to international currency conversions. We understand that this does represent a 12 - 15% price rise in our current pricing, but as was previously explained in Newsletter #1 the collapse of the Australian dollar in November 2008 against the US dollar has made this rise necessary. Compared to existing testosterone treatments (such as AndroGel in the USA ) Andromen Forte still represents a substantial cost saving.

New measuring devices

The new more accurate dose measuring devices are soon to be included in the boxes of all products. While making this transition we have made modifications to the tube nozzle, tube cap and security seal for a more user friendly and exact dose application. Please read the updated Consumer Medicine Information sheet inside the box which explains fully the way in which to use the new measuring device correctly. A short video clip will be available on our website demonstrating how the device is used for measuring the cream once the change over takes place. We expect all products to be supplied with the new measuring devices by December 2009.

New Information Booklets

We have developed a comprehensive range of information booklets on various medical conditions intrinsically linked to hormone deficiency states. The booklets cover topics such as hypogonadism in men, hypogonadism in children, pregnancy, miscarriage, Klinefelter's Syndrome, castration, hysterectomy, polycystic ovarian syndrome (PCOS), ovulation, infertility, menopause, dysfunctional uterine bleeding and estrogen dominance. We will be adding more subject titles to these over the coming months.

Click on any of the images below to download the booklet at no charge. The booklets can also be downloaded from the Hormone Solutions website.

Advance notice: New product NATRAGEN estradiol cream 0.2%

With the increased demand for bio-identical hormone replacement therapy Lawley Pharmaceuticals has decided to re-launch their natural estrogen product - NATRAGEN. Natragen contains the bio-identical hormone estradiol for the management of estrogen deficiency states. Despite the bad press estrogen has received over the past few years it is an essential hormone to the overall hormonal balance in women. Over prescribing and over dosing of synthetic estrogens has scared many patients and doctors from using estrogen to manage short-term menopausal symptoms such as hot flashes, night sweats and vaginal dryness. Using the low dose bio-identical Natragen topical cream adds a small amount of natural estradiol into the body to control these often debilitating menopausal symptoms. Natragen is expected to be available in Feburary 2010.

Lawley Pharmaceuticals on display in December 2009 in Las Vegas

Lawley Pharmaceuticals will be exhibiting at the 17th Annual World Congress on Anti-Aging Medicine and Regenerative Biomedical Technologies in Las Vegas, USA from 10-14 December 2009. This major medical conference attended by over 6000 physicans and health professionals from the US and beyond will showcase the Lawley Pharmaceuticals products. Our CEO Michael Buckley will be presenting a lecture on the benefit of scrotal testosterone application over topical or injectable forms of testosterone administration. The congress will be a landmark event to showcase the quality and efficacy of Lawley Pharmaceuticals' products. Pleae come and visit our booth if you're in Las Vegas during these dates!