FDA Approved Treatment for Postmenopausal Osteoporosis Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now [...]]]> Laurie Barclay, M.D. – Medscape, LLC

 FDA Approved Treatment for Postmenopausal Osteoporosis
Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now known as menopausal hormone therapy (MHT). The statement, entitled “Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement,” was also posted online ahead of print on June 21 and presented in San Diego, California, at ENDO 2010: The 92nd Annual Meeting & Expo.

Although MHT was in widespread use in the 1990s in hopes of lowering cardiovascular disease risk as well as to treat menopausal symptoms, the Women’s Health Initiative (WHI) Study showed that MHT was actually associated with an increased risk for heart disease, stroke, and breast cancer. However, recent evidence suggests that these risks may be affected by time after onset of menopause when MHT was started, a factor not considered in the WHI assessment of MHT safety and efficacy.

“Before the WHI, MHT was believed to prevent heart disease, fractures, memory loss and dementia in addition to relieving uncomfortable menopausal symptoms,” said task force chair Richard J. Santen, MD, professor of medicine at the University of Virginia in Charlottesville, in a news release. “Following the WHI reports of increased health risks associated with MHT, MHT use declined by 80%. New data however [show] that these health risks may not apply to all women using MHT, and that MHT may in fact be very beneficial to some women.”

Controversy regarding WHI’s applicability to women just entering menopause stems from the fact that the average age of participants was 63 years, and only 3.5% of the women were aged 50 to 54 years, which is the age range when women typically decide whether to start MHT. Furthermore, the WHI did not address menopausal symptom relief. Therefore, this scientific statement considered new data from later studies evaluating the effects of MHT in women aged 50 to 55 years.

Compared with women who begin MHT after age 60 years, those who begin MHT a short time after onset of menopause at ages 50 to 59 years appear to benefit. According to recent evidence, women in the short-time group using MHT for 5 years had a 30% to 40% reduction in mortality risk and no increased cardiovascular disease risk. In addition, they had a 90% decrease in hot flashes, overactive bladder, or other menopausal symptoms.

“Some women in the short-time group still developed breast cancer but only with the combination of estrogen plus a progestogen, not with estrogen alone,” Dr. Santen said. “This may be due to the stimulation and uncovering of very small, undiagnosed breast cancers, rather than causing these cancers de novo.”

Conclusions Reached

Evaluation of the new data along with WHI evidence led the task force to reach the following conclusions, with level of evidence A:

• “Standard-dose” estrogen used with or without a progestogen is associated with marked reduction in frequency and severity of hot flashes. For many women, lower doses of estrogen are also effective.
• An alternative hormonal therapy for postmenopausal vasomotor symptoms is tibolone, which is widely available worldwide, but not in the United States.
• For symptoms of vaginal atrophy, very low doses of vaginal estradiol are effective.
• Symptoms of overactive bladder may be reduced by estrogen given vaginally or systemically.
• Vaginal estrogen is associated with lower rates of recurrent urinary tract infections.
• Tibolone improves urogenital atrophy.
• For women in late postmenopause, estrogen given with or without a progestogen is as effective as bisphosphonate therapy for preventing early postmenopausal bone loss and increasing bone mass.
• Use of estrogen alone and estrogen plus a progestogen is associated with a lower incidence of hip and vertebral fractures.
• For osteoporotic women older than 60 years, tibolone is associated with significantly lower rates of vertebral and nonvertebral fractures.
• Treatment with the selective estrogen receptor modulator raloxifene is associated with increased bone mineral density and lower rates of vertebral, but not hip, fractures.
• Use of MHT containing estrogen plus a progestogen is linked to a lower risk for colon cancer.
• Raloxifene is associated with a lower risk for breast cancer.
• Mammographic density is increased in women taking estrogen alone or with a progestogen.
• Use of tibolone is associated with a greater risk for breast cancer recurrence.
• Sexual function is improved by physiologic amounts of transdermal testosterone, but not by dehydroepiandrosterone.
• Risk for venothrombotic episodes is approximately doubled in women using MHT, and this risk is multiplicative with baseline risk factors such as age, increased body mass index, thrombophilias, surgery, and immobilization.
• Use of raloxifene is associated with an increased incidence of venothrombotic episodes.
• In older, but not younger, women, tibolone is associated with an increased risk for stroke.
• Raloxifene is not associated with any increase in stroke risk.
• In older women with preexisting vascular disease, hormone use does not reduce stroke incidence.
• Although continuous estrogen plus a progestogen does not cause endometrial cancer, estrogen alone without a progestogen is associated with an increased incidence in endometrial cancer.
• Tibolone is not associated with an increased incidence of endometrial hyperplasia or carcinoma.
• Risk for gallbladder disease is increased in women using estrogen alone or with a progestogen.
• MHT started after age 60 years does not improve memory.

“It is important to remember that most women considering MHT are between the ages of 50 and 55 and in this group MHT may have many benefits,” Dr. Santen concluded. “Physicians and their patients need to re-think the use of [MHT] based on data pertinent to the 50-55 year old and therapy should be individualized based on symptoms and underlying risks of breast cancer and heart disease.”

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or [...]]]> FDA NEWS RELEASE

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

 OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

 “Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

 According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

 OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

 Gayle R. Lewis, Esquire

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such [...]]]> Source: The Legal Intelligencer, June 2010

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such a devastating circumstance. We at the Lewis Law Firm want to hear from any family who has not yet exercised their rights to seek compensation. Contact us.

 Posted: Gayle Lewis, Esquire

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what [...]]]> Source:  BBC Health; Journal Nature Medicine.

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what they’re really good for) have demonstrated reason to be hopeful.  There are currently two cancer vaccines approved for use in the US, however neither of these actually prevent cancer.  One (Gardasil) prevents HPV while the other prevents Hepatitis B, both precursors to cancers.  If the breast cancer vaccine is effective in human trials it would be the first vaccine against cancer tumors.

Some background is in order.  Cancer actually describes a process of rapid and unrestrained cell growth.  The inability of the human body to switch off the growth of cells results in formation of clusters of cells forming tumors or spreading (metastasizing) throughout the body.  Where viruses are foreign to the immune system and defended against, cancerous cells are not.

The vaccine would target the proteins at the cellular level so that they can not continue to form tumors.  Unlike traditional chemotherapy (chemical agents) or radiation, which destroys not only cancer tissue but a good deal of healthy tissue and organs with it, a targeted vaccine would actually prevent one from ever developing breast cancer (in theory) in much the same way that the polio vaccine prevented generations of children from contracting polio.

Definitely one to watch.

~Posted by D.M. Schwadron, Esquire

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International [...]]]> Source: Medscape Medical News

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International Journal of Cancer (2009: 125:362-366) rates of HPV related oropharyngeal (mouth and throat) cancer were 23.3% in the 1970′s, 57% in the 199o’s and up to 93% in 2006-20007.

Why the increase in oral cancer?  According to researchers it’s due to an increase in oral in general.  Yes, some things do write themselves.  Apparently it can take from 15 to 30 years for HPV to develop into cancer.  While there is some concession that much of this is speculation as people are not necessarily candid in providing such information to researchers, the implications for treatment could be significant.

It is medically accepted that HPV causes cancer.  In fact, the molecular mechanisms are well known enough for the development of the available HPV vaccine.  Currently, the HPV vaccine is targeted to young women for the prevention of cervical cancer, which can originate from HPV.  The vaccine was also recently approved for use with young men to prevent genital wart infection.

But could the same vaccine eventually be used to prevent against HPV-related oral cancer?  Well, one would expect that it might, however, genital surfaces and fluids do differ from oral surfaces and fluids so no one is actually certain.  The efficacy of the currently available HPV vaccine appears clear.  But is it cost effective?  That is, will big pharma seek to develop a vaccine for something potentially ineffective and potentially socially problematic.

Not as unusual as it might seem given our Puritanical heritage.  Remember, if the studies correlating sexual behavior with increased incidence of oral HPV are correct this would seem to limit the transmission of this type of cancer to an act still defined as sodomy in many states in the United States and criminalized in some.

Perhaps the only other social-medical parallel would be with the medical marijuana debates going on in most states.  Where medicine and societal “norms” or “values” intersect is where we start getting into problem territory.  The manufacturers and marketers of the HPV vaccine took a lot of criticism for essentially targeting school-aged girls.  When one finally “gets over” the fact that school-aged girls are sexually active the criticism seems nonsensical.  A vaccine which could potentially prevent women from dying in their middle age from cancer inherently seems like a worthy investment.  We will follow the emerging debate on this one.

~Posted by D.M. Schwadron, Esquire

YAZ Litigation

The newest litigation on the mass tort front continues to center upon birth control.  Specifically Yaz (drospirenone and ethinyl estradiol), Yasmin and Ocella.  These 4th generation (yes, pills have generations too) birth control pills were lauded for their effectiveness and initial advertisements (for which the FDA issued a warning [...]]]> Source: U.S. Food and Drug Administration

YAZ Litigation

The newest litigation on the mass tort front continues to center upon birth control.  Specifically Yaz (drospirenone and ethinyl estradiol), Yasmin and Ocella.  These 4th generation (yes, pills have generations too) birth control pills were lauded for their effectiveness and initial advertisements (for which the FDA issued a warning to Bayer) suggesting their role in treating PMS.

The Yaz label has underwent a number of revisions to add the numerous warnings associated with the use of YAZ including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and
hypertension. Moreover, YAZ has additional risks because it contains the progestin, drospirenone.

Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking YAZ must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.  Consolidated litigation is currently in the Court of Common Pleas of Philadelphia.  IF YOU BELIEVE THAT YOU WERE HARMED BY YAZ PLEASE CONTACT OUR OFFICE TODAY.

Next up, MasXtreme (Yes, it’s exactly what it sounds like)

Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement (A nod is as good as a wink to a blind bat) contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker. Aildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). This may pose a threat to consumers because Aildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed Nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.

Consumers who have purchased MasXtreme tablets (And you know who you are) are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm¹. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm². Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

~Posted by D.M. Schwadron, Esquire

Dutasteride (Avodart according to GalxoSmithKline) is used to treat an enlarged prostate. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH (benign prostatic hypertrophy), such as frequent and difficult urination, and decreases [...]]]> Source: New England Journal of Medicine; BBC Health

Dutasteride (Avodart according to GalxoSmithKline) is used to treat an enlarged prostate. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH (benign prostatic hypertrophy), such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.

Why am I telling you this? Have I suddenly started working for GlaxoSmithKline and wish to pitch their on-patent medications to stave off the competition from the generics?  No.  Not at all.  I’m telling you because the results of a 4 year study of some 6,500 men taking dutasteride showed a 23% lower risk of prostate cancer compared with those taking a placebo (a fake pill, typically made of sugar).

This isn’t the first study to initially show promise. In 2003, a study of men taking finasteride, a BPH drug now marketed as Propecia by Merk.  (Yes for hair loss), was said to also lower the risk of prostate cancer.  However, there were issues with the aggressive nature of the tumors found in that group.  Oh and both medications can cause sexual dysfunction and frequent and painful urination.

The Glaxo funded study (you had to know that) looked at men aged 50 to 75 years in the “high risk” for prostate cancer category given elevated PSA scores but without demonstrable cancer.  Among those with a family history of prostate cancer, those also taking dutasteride are reported to have cur their risk of developing cancer by 31.4%.  Why the disparate numbers?  It’s not clear.  And what about the tumors that did develop?  The researchers felt that those found during the trial were likely present to begin with but too small to be detectable.  According to them, this suggest that the drug shrinks early prostate tumours or keeps their growth at sub-detectable levels.  (The later of which doesn’t appear to be all that helpful).

The proponents of the study believe that the drug might offer thousands of men a simple way to reduce their risk of disease.  This would mean that more men with a high PSA could potentially avoid unnecessary or more involved treatment including surgery on the prostate, chemotherapy and radiation and all of the attendant side effects and symptoms which follow.

Others, like Dr. Helen Rippon of the Prostate Cancer Charity, aren’t so charitable.  (See what I did there?)  According to Dr. Rippon, “[W]e don’t yet know what will happen to these men in the coming years and whether they will still go on to develop the disease [Prostate Cancer] and it will be many years before we know if the drug [dutasteride] can provide any long-term benefit to men.”

~Posted by D.M. Schwadron, Esquire

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You [...]]]> Source:  BBC Health; European Breast Cancer Conference, Barcelona

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You may have heard of a drug called Imitrex, used for the treatment of migraines.  Well it was originally formulated as an anti-seizure drug with mixed results.  A few accidental results and a new generation of migraine treatments was born.

Not familiar with that one?  Okay, you may have heard of a drug called Viagra which is fairly well-knonw (to the internet spam community in particular).  Well, Viagra, was an anti-hypertensive drug which despite years of development and testing did less for hypertension than it did for…well, you get the idea.

Enter beta blockers, a classification of blood pressure medications estimated to be currently prescribed to over two million people in the UK alone.  A team of UK and German researchers has found that in a study of women with breast cancer tumors, those taking beta blockers had a 71% lower chance of dying from metastatic (spreading) disease.

Granted the study was small, focusing upon some 466 European women with breast cancer.  However, the results could be significant.  Breast cancer remains the single largest killer of women, with some 30,000 diagnosed in the UK each year.  It is thought that beta blockers may also block hormones which trigger the spread of cancer cells beyond the breast.  The chances of curing breast cancer differ remarkably where cancer can be confined to the breast or to a small area of the breast.  Once cancer metastasizes (spreads) throughout the body, chances of a cure diminish.

Beta blockers attach to the same cancer cell receptors as metastatic associated hormones, thereby reducing the ability of the cancer cells to spread beyond the confines of a tumor.  So it may just be that the hope for a “new” drug to treat breast cancer exists in an old drug, beta blockers, which have been used for years now with relative safety.  It is hoped that a combination of existing chemotherapy drugs and beta blockers may offer breast cancer patients greater chance of cure and certainly greater chance of confining, and thereby surviving, breast cancer.

The even better news?  Unlike the introduction of a completely new drug, the re-purposing (If I may) of a drug isn’t as rigorous a process and it appears that the studies are well into the clinical trial stages.  Granted this is taking place in Europe and our FDA may not be as enlightened.  However, this also means that it might not take another 7 years for beta blockers to emerge as accepted treatment for breast cancer.

~Posted by D.M. Schwadron, Esquire

Roughly equivalent to our JCoHA (Joint Commission) here in the US, the NPSA has been taking notes on the administration of medications in English and Welsh Hospitals.  Their findings?  In every hospital in England and Wales, there were reports of patients not receiving their medications on time or [...]]]> Source: BBC Health; National Patient Safety Agency (NPSA)

Roughly equivalent to our JCoHA (Joint Commission) here in the US, the NPSA has been taking notes on the administration of medications in English and Welsh Hospitals.  Their findings?  In every hospital in England and Wales, there were reports of patients not receiving their medications on time or at all.

From 9/06 to 6/09, the NPSA recorded reports of 68 cases of severe injury and 27 deaths with an additional 21,000 cases of drug administration delays or non-administration.  Since reports to the NPSA are voluntary, the organization believes that these figures are underestimated.

Alarmingly, antibiotics (drugs to treat infection) and anticoagulants (blood thinners) and cardiac drugs are the most likely to harm patients if missed.  Although even antidepressants and Parkinson’s Disease drugs can have dramatic effects upon patient wellness if they are not timely received.

And if this is happening in England and Wales, consider the implications for an area as populated as the US with all of its hospitals and nursing home facilities.

~Posted by D.M. Schwadron, Esquire