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Archive for December, 2010

Mexican pharmacy news

24 Dec

Vyvanse for ADHD in Teenagers

Lisdexamfetamine dimesylate capsules (Vyvanse, Shire) have been approved for the treatment of attention adolescents 13 to 17 years of age. Vyvanse was previously approved for treating ADHD in adults and children 6 to 12 years of age. The new approval was based on results from a randomized study of 314 adolescents.

Vyvanse is a federally controlled substance (CII) because it can be abused or may lead to dependence. It is available in six once-daily dosage strengths of20, 30, 40, 50, 60, and 70 mg.
Sources: FDA and Shire, November 15, 2010

Sprycel for Rare Leukemia

Dasatinib (Sprycel, Bristol-Myers Squibb) has been approved for patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. This slowly progressing blood and bone marrow disease is linked to a genetic abnormality.

An oral kinase inhibitor, dasatinib is believed to block the activity of proteins responsible for the growth of cancer cells so that the bone marrow can start reproducing normal red and white blood cells.

In 2006, the FDA granted accelerated approval for dasatinib to treat adults with CP-CML with disease that was resistant to previous therapy, including imatinib (Gleevec, Novartis). In 2009, formal approval was granted.

Bristol-Myers Squibb has launched My Sprycel Support to help patients learn more about the drug. Patients also have access to a care counselor 24 hours every day.
Source: FDA, October 28, 2010

Afinitor for Rare Brain Cancer

Everolimus (Afinitor, Novartis) is now approved to treat subependymal giant cell astrocytoma, a benign brain tumor that is associated with tuberous sclerosis. Tuberous sclerosis is a rare genetic disorder in which tumors grow in the brain, eyes, lungs, liver, heart, skin, and kidneys. Signs may include learning disabilities, skin abnormalities, seizures, and lung and kidney disease.

Everolimus tablets were first approved in March 2009 to treat kidney cancer patients who were not responding to sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer). Everolimus is also approved as Zortress (Novartis) for preventing organ rejection after kidney transplantation.
Source: FDA, November 1, 2010

Cymbalta for Chronic Pain

The FDA has approved duloxetine HCl (Cymbalta, Eli Lilly) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Duloxetine is also indicated for major depressive disorder, diabetic peripheral neuropathy and fibromyalgia, generalized anxiety disorder, and maintenance treatment of major depression.

The FDA assessed the drug’s efficacy in four randomized clinical trials. At the end of the study period, patients taking duloxetine had a significantly greater pain reduction compared with those taking placebo.

The recommended dose is a 60-mg capsule taken once daily without regard to meals.
Source: FDA, November 4, 2010

Herceptin for Stomach Cancer

The FDA has expanded the indication for trastuzumab (Herceptin, Genentech) to include the initial treatment of HER-2- positive (HER-2+) metastatic cancer of the stomach or gastroesophageal junction in combination with chemotherapy.

Trastuzumab has improved outcomes in women with HER-2+ breast cancer. HER-2 protein is also overexpressed in some stomach cancers. The drug blocks HER-2 and is used to treat early-stage and advanced HER-2+ breast cancer.

The drug was evaluated in the phase 3 ToGA study. Half of the patients received chemotherapy alone, and half received chemotherapy plus trastuzumab. Chemotherapy comprised a fluoropyrimidine (capecitabine [Xeloda, Roche]) or 5-flu- orouracil (5-FU) and cisplatin (Platinol, Bristol-Myers Squibb). Overall survival rates were 13.8 months with chemotherapy plus trastuzumab and 11.1 months with chemotherapy alone.
Sources: Reuters and Genentech, October 20, 2010
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Medications news

23 Dec

Teflaro for Bacterial Infections

Ceftaroline fosamil (Teflaro, Forest), an injectable antibiotic, has been approved to treat adults with community- acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA).

Ceftaroline is a cephalosporin, which acts by interfering with the bacterial cell wall. The drug’s safety and effectiveness were evaluated in four phase 3 clinical trials in patients 18 years of age and older. Adverse effects included diarrhea, nausea, and rash.

Source: FDA, October 29, 2010

KL4, an Orphan Drug For Cystic Fibrosis

An orphan drug designation has been approved for Discovery’s KL4 surfactant for patients with cystic fibrosis (CF). CF is caused by a genetic mutation that can cause life-threatening lung infections and premature death. Previous studies had suggested that a surfactant might improve mucociliary clearance, perhaps with the potential to prevent further compromise of lung function.

Discovery completed a double-blind, randomized crossover phase 2a study in which the aerosol surfactant was generally safe and well tolerated. Patients experienced improved mucociliary clearance, and no associated serious adverse events were reported.

Source: Drug Discovery Dev, November 2, 2010

Latuda Benefits Adults With Schizophrenia

Lurasidone HCl tablets (Latuda, Sun- ovion) have been approved for the treatment of schizophrenia in adults. Like other atypical antipsychotic agents, lurasidone carries a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older adults with dementia-related psychosis. Lurasidone is discussed in this month’s Pharmaceutical Approval Update on page 693.

Source: FDA, October 28, 2010

Egrifta Treats Lipodystrophy In HIV Infection

The FDA has approved tesamorelin injection (Egrifta, Theratechnologies, Inc./EMD Serono) to treat HIV patients with lipodystrophy. This condition, in which excess fat develops around the liver, stomach, and other abdominal organs, is associated with many antiretro- viral drugs.

Tesamorelin is a growth hormone- releasing factor that is administered once daily. In two clinical trials, patients receiving tesamorelin experienced greater reductions in abdominal fat, compared with patients receiving placebo. Some patients also reported an improved self- image.

Adverse effects included joint, stomach, and muscle pain; erythema and pruritus at the injection site; swelling; and worsening blood glucose control.

Source: FDA, November 10, 2010

Halaven for Breast Cancer

Eribulin mesylate (Halaven, Eisai) has been approved to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Eribulin, a microtubule inhibitor, is a synthetic form of a compound derived from the sea sponge Halichondria oka- dai. Before therapy, patients should have received prior anthracycline-based and taxane-based chemotherapy for early or late-stage breast cancer.
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In a randomized study of 762 women, median overall survival rates were 13.1 months with eribulin and 10.6 months with a different agent. Adverse effects included neutropenia, anemia, leuko- penia, hair loss, fatigue, nausea, peripheral neuropathy, and constipation.

Source: FDA, November 15, 2010

Gablofen for Spasticity

CNS Therapeutics has announced the FDA’s approval of Gablofen (baclofen) injection for use in the management of severe spasticity. This movement disorder affects more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke.

Originally developed in the 1920s as a potential antiepileptic drug, baclofen was also found to be safe and effective for reducing spasticity. In the early 1980s, the drug was noted to be more effective when delivered intrathecally. Baclofen intrathecal injection was first approved in 1992 as an orphan drug and is now considered the standard of care for patients with severe spasticity of spinal and cerebral origin.
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Gablofen is administered in the same standard concentrations as Lioresal Intrathecal (Novartis): 50 mcg/mL, 500 mcg/ mL, and 2,000 mcg/mL. It is sold with ready-to-use vials and pre-filled syringes offering clear advantages over glass ampules, including a faster refill preparation time and a lower risk of product con tamination.

The company’s research was partly funded by a grant from the Michael J. Fox Foundation.

Source: CNS Therapeutics, www.cns- therapeutics.com, www.gablofen.com

 
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Eczema Symptoms and Treatments

21 Dec

Itchy, blotchy and reddish swelling area on parts of your skin is clear signs of Eczema. It is a skin condition that is usually caused by bacteria as well as other factors. The skin becomes dry, flaky and even scaly. It is a terrible sight to see but even a worse thing to experience. To be prepared for an eczema onslaught, you should know the eczema symptoms and treatments available to be able to prevent and control the skin disorder.

The eczema symptoms and treatments are both easily acquired and they are dangerous too. That might be hard to believe but some basic treatments for this symptoms are harmful and ineffective in the long run. Good thing though there are tell-tale signs that point to eczema symptoms and treatments are there that can actually take care of the skin disorder.

Most of the time people can’t seem to handle the effects and treatments can be expensive as well as gross. Ointments and creams are not really a good sensation on the skin, especially those found in pharmaceutical clinics. However, when it comes to eczema symptoms and treatments, people sometimes just don’t have that many choices. Good thing there are ways to create natural treatments out of natural herbs and ingredients organically grown.

The great thing about herbs and its role on eczema symptoms and treatments is the fact that they contain all natural ingredients. Symptoms are caused by bacteria and what better way to treat bacteria but with good bacteria, right? That is why some of these natural products have probiotics in them to counteract the bad bacteria.

Since eczema has also been known to be caused by stress, herbs such as chamomile and peppermint can prove quite effective treatments for you. These herbs can help soothe your body plus these help you relax allowing your body to heal properly.

Eczema symptoms and treatments should both complement each other. This is because there are different types of eczema and the symptoms are different and may vary with every person. Just as our genetic make ups are unique, so is our immune system and skin cells.

Other eczema symptoms and treatments can appear and work on other people but might not occur and work for you. So, to better handle everything, you need to research the different triggers as well as the variety of solutions that can actually help you get your smooth skin back.

 
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Food and Depression

07 Dec

Healthy food makes a healthy mind

This is the very first and most critical step in returning to full health of mind and body.

Learning how to eat natural, vital, healthy food is a process. It’s something that we have to learn to do and that means working at it. As with learning anything truly worthwhile, this does require a degree of self-discipline. This self discipline will usually only arrive when you finally realize the importance of what you are putting into your body — and into brain.
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Understand that your mind is housed in your brain and your brain is part of your body. Whatever you feed your body affects your brain – and therefore it affects your mind and your mood. After all, it is your mind that controls how you feel.

The farther away you get from quick, processed foods and the closer you get to natural, unprocessed foods the better you will feel.

Some of us have to start again from scratch, changing most of our eating habits along with most of what we put into our bodies – and consequently our minds. But be assured – it truly is worth it!

You know only too well that what you have been doing has not worked so well. If it had, you would be feeling a great deal different.

Yes, tradition is wonderful and habit can be reassuring, but are your eating habits truly helping, or are they harming you? Do all aspects of tradition need to dictate who you really are, if a big part of you doesn’t feel good as a consequence? Can you still retain tradition while making modifications that will work in your favor? Does it really matter what everyone around you is doing or has been doing all of their lives?

It may work for them, but it doesn’t seem to have worked for you because you have not been feeling well. Does it really matter so much what you have been taught to eat in the past; does it really does matter what everybody around you is eating – or is your own emotional and mental well being somehow more important.

Treat this as a real journey of discovery; a journey towards real and lasting health of mind and mood. The two really cannot be separated. You may very well have to leave your traditional comfort zone for a while and allow yourself to experiment, but this doesn’t need to frighten you.

In fact, if you allow it to, it can do the reverse – it can bring a degree of adventure, autonomy and an even greater sense of purpose back into your life. And if you have been feeling depressed, then that sense of adventure, autonomy and purpose may very well be something that has been missing for a long time.

Let me explain what you need to do in order to feel better in a nutshell:

1. Replace the essential fatty acids in your brain. Your brain is more than 50% fat – but it is essential that it’s the right kind of fat.

Eliminate hydrogenated, saturated and damaged ‘trans’ fats, which means avoiding fast foods, and incorporate foods high in Omega 3 fatty acids – organic eggs from chickens fed additional Omega 3 oils with their feed; wild fish, oily fish such as mackerel, seaweed and algae.

Consider taking an Omega 3 supplement containing EPA and DHA, together with a good Omega 6 oil such as evening primrose or star-flower oil, all readily available from good health food stores.

Avoid deep-fried foods and switch to extra-virgin cold-pressed olive oil where possible.

2. Eat whole grain, low GL index foods (check for lists of GL foods on the internet), fresh vegetables and fruit (preferably organic if the budget will allow), soya products such as tofu (but not soya oil), fresh eggs and fish. (Avoid tuna because of its mercury and other heavy metal content.) Combine this with a reasonable amount of nuts and seeds.

3. Eliminate most sugars and simple carbohydrates together with all caffeine.

4. Eat plenty of low fat protein (preferably from non-hot-bloodied animals), fish, soya products, Quorn, nuts and seeds etc. These provide the essential amino acids that you need in order to function and feel well.

5. Take extra vitamin B6, B12 and folic acid, preferably in a complete mega-vitamin B complex tablet, together with 1000 mg vitamin C daily. Also take a good multi vitamin-mineral tablet that contains vitamin D, magnesium, zinc and chromium picolinate daily.

6. Consider taking a 5-HTP supplement. This powerful natural supplement has been shown to raise serotonin levels in the brain and has been used in Europe as a treatment for depression for some time now. Be sure to check with your healthcare practitioner before taking 5-HTP to make sure that it is not contra-indicated in your particular case.

And it should go without saying – never skip breakfast!

If you’ve been experiencing depression then you’ve probably been far too serious for far too long – but have you been serious in the right way? Now is the time to get serious about what you put into your body and therefore into your mind.

In depression we tend to greatly devalue our self. Eating the right foods and taking the right nutritional supplements is exactly the opposite of this.

Now is the time to make those changes that you need to make in order to feel much better. Do this and reap the rewards in how you feel, think, and look at life.

 
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The Best Way to Avoid Knee Pain

04 Dec

As time passes, most of our bones, joints and muscle tissues will put through wear and tear that could make these organs less efficient in its function and also much more vulnerable to damage. Consequently, it’s vitally important to cater to these effects when an elderly person is being treated or as a preventive measures.

Of all the joints in the body, the knee joint is most likely one of many joints that takes brunt of the stressors and will be the primary site for complaints of pain among the elderly age group. The pain could arise from a variety of components also it could be the bones, cartilages, muscles or tendons. The pain that is felt can be a localized chronic ache otherwise an agonizing acute Knee Pain which sometimes radiate up or down in the affected leg.

A person, particularly the elderly, is most probably to endure these painful conditions that would certainly affect the persons activities of everyday living. Therefore, how are we going to avoid such incidence? Following are few suggestions of Knee Pain Treatment or preventive measures.

1. Put on correctly fitting shoes or sandals when walking or doing exercises.

2. Avoid running or exercising on uneven surfaces and make use of properly laid down tracks or flat surfaces in performing such exercises.

3. Put on knee guards when exercising or walking to give it support in maintaining stability while the movements are taking place.

4. Do sufficient warm up prior to indulging on strenuous exercise or physical activities then warming down exercises would also be helpful.

5. Give sufficient rest following prolonged standing, walking or following working out in order to allow the knees to recover from acute stressors.

6. Hot fermentation of the knee joint as well as cold compressions is a great type of Knee Pain Treatment since it reduce and revitalize the knees for the another day.

7. Staying away from prolonged immobility is also a significant step in preventing knee joint pain in addition to limited movements.

8. Getting healthy nutritional foods which consists of sufficient calcium, nutritional supplements would benefit in stopping prolonged joint pain and would help a fast recovery process subsequent minor injuries.

9. Avoid heavy lifting in abnormal postures as disproportionate weight distribution can bring about knee injuries and strains thereby causing pain.
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Consequently, adequate precautions in addition to healthy habits will lead to protection of the joint and therefore the avoidance of nagging knee joint pain.

 
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Hip Replacement

03 Dec

So you’re an active baby boomer, or even younger, and you’ve found that one of your hips is either becoming very painful, curtailing your activities, or not responding to medications.
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You’ve exhausted the drugstore shelf dedicated to arthritis, and various muscle and joint aches.

Perhaps you’ve already seen your doctor, had an examination that proves you’ve lost some range of motion, and/or had an x-ray made that shows “arthritis”. The next step is most likely a visit to your friendly orthopedist. Here, you’ve been given the news! And the news is-that your problem, should you wish it to be definitively solved, involves major surgery. Major in the sense that the surgical procedure is medically so considered; Major in that it will require a lot of time and attention from you; Major in that it is a serious option you must face. And so you begin to consider- a total hip replacement or a hip resurfacing.

You’ve heard that the conventional total hip replacement has an average survival life of 15 years, after which it may have to be replaced-the so called surgical ‘re-do’. But now you learn too, there is an alternate procedure designed for younger, active patients of somewhere between 40 and 60, called a hip resurfacing. The ‘Resurf’, can give you 10, 15, or even more years before it may be required to be converted into a total tip replacement (the figures on life expectancy of a Resurf are not entirely fixed yet) As the experience is still too young for the studies in medical literature to be more definite.

A little basic anatomic information may help explain the difference between these two procedures. In essence the hip is a ball and socket joint. In both procedures the socket is revised and replaced. But the resurf, doesn’t replace all the bone of the ball part of the hip joint-particularly the part that anchors it in the femoral or thigh bone. Hence more anatomy is left intact.

The resurf procedure being offered to younger patients with enthusiasm by the orthopedic surgical community has some decidedly positive advantages if you’re a member of this younger group of patients.

  • Quicker recovery time
  • Greater safe range of hip motion,
  • Earlier rehab(generally)
  • Preservation of more bone stock

All of these things make a hip resurfacing by an experienced surgeon desirable for the younger patient.
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But just like this year’s newer better car model, the resurf is not without glitches. The following have produced lots of material for the professional literature and it is as well that candidates for the resurf procedure get in the know.
The learning curve for the performing surgeon is extremely steep. I personally would require that my surgeon do a minimum of 30 plus resurfs a year.
There is a noticeable incidence of femoral neck fractures following resurf. This is especially true for pre or peri-menopausal women, or any patient with Osteopenia (a diminished presence of calcium in the body’s bones- seen on x-ray or detected by bone density tests).
It is not the safest procedure for the obese (those whose body Mass index is over 30), or for those whose hip anatomy is significantly irregular or distorted.
Many of the implanted resurfs have been of a metal-on-metal construction, and are subject to the same metal particle shedding problems, and therefore to the same recall as the metal-on-metal total hips.

Of the two procedures, the total hip replacement has a more solid success percentage, and is less demanding of surgical technique.

What I am saying is, if you need a new hip, you need a new hip, but consider the matter carefully before you opt for this year’s model (the hip resurfacing) and take advantage of it only after knowing fully its risks.
Dr. Mary Ellen Hecht is an orthopedic surgeon and author of a new book, “A Practical Guide to Hip Surgery”. This concise handbook augments pamphlets or videos supplied in your surgeon’s office. The book as well as this article is written in user friendly English, but has the gravitas of thirty-five years of medical practice directly from an orthopedic surgeon who has performed countless hip surgeries and undergone a double hip replacement herself!

 
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