Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts
Thursday, October 16, 2014
Tuesday, April 8, 2014
FDA Advisory Panel Endorses Inhaled-Insulin Product Afrezza
A US Food and Drug Administration (FDA) advisory panel has voted in favorof MannKind's Afrezza (Technosphere insulin-inhalation system) for the treatment of both type 1 and type 2 diabetes in adults.
Votes of the Endocrinologic and Metabolic Drugs Advisory Committee in favor of Afrezza were 13-1 for type 1 diabetes and 14-0 for type 2 diabetes. One panel member left early and did not vote.
Afrezza consists of a premeal insulin powder loaded into a cartridge for oral inhalation. The company is seeking an indication as an ultrarapid-acting insulin for adults with type 1 or 2 diabetes. In type 1 patients, the indication would be for use with injected basal insulin.
Panel members cited the advantages of more rapid onset of insulin action and shorter duration, resulting in a lower risk for hypoglycemia, as well as the potential for greater acceptance of inhaled-insulin therapy for patients with type 2 diabetes who might otherwise refuse or be unable to self-inject insulin.
However, the panel did express concern about data suggesting lower glucose-lowering efficacy compared with injected short-acting insulin (aspart) in type 1 patients and about lack of long-term lung-function data beyond 2 years, as well as a possible signal for lung cancer.
Panel members presented the agency with a long list of recommendations for postmarketing studies and labeling requirements to address those issues, among others.
Risks vs Benefits
Technosphere insulin begins working within 12 to 15 minutes, peaks by 30 minutes, and is essentially cleared by 180 minutes. Current rapid-acting insulins, in contrast, peak at about 1 hour and remain in the circulation up to 5 hours.
In a pivotal trial involving 353 patients with type 2 diabetes inadequately controlled on 1 or more oral agents, Afrezza was superior to placebo in lowering HbA1c at 24 weeks, with a week-24 treatment difference of -0.40 (P< .0001). However, in a pivotal study of 344 patients with type 1 diabetes, Afrezza had significantly inferior HbA1c reduction compared with premeal injections of insulin aspart, although the difference remained within the prespecified noninferiority margin.
Rates of severe hypoglycemia were 43% lower among the type 1 patients with premeal Afrezza compared with aspart injections.
Cough was the most common adverse event, occurring in 27% of all the study subjects and leading to discontinuation in 3%. Small decrements in forced expiratory volume in 1 second (FEV1) of about 40 to 60 mL were noted within the first 3 months and persisted for the 2 years of follow-up, although there wasn't further progression.
Because of the risk for bronchospasm in patients with underlying lung disease, including chronic obstructive pulmonary disease (COPD) and asthma, the product would be contraindicated in those groups, and the label would include recommendations for screening of patients for these conditions before starting them on Afrezza and possibly for periodic ongoing monitoring of lung function as well.
A total of 4 cases of lung cancer occurred in patients who had used Afrezza, 2 during the trial in smokers, and 2 others, both squamous-cell tumors, at 2.6 and 3.8 years after the end of the trial in nonsmokers. An oncologist on the panel, Liz Szabo, MD, from the National Cancer Institute, called that "unusual" and advised that more data be collected.
Pulmonologist James K. Stoller, MD, of the Cleveland Clinic Foundation, voted yes for both type 1 and type 2 because he was "extremely impressed by the unmet need and the advantages of this drug for subsets of individuals." Nonetheless, he said he remained concerned about the potential for the product's use in patients with unrecognized COPD and expressed skepticism about the extent of adherence to a label recommendation for spirometry.
"I think we sometimes take solace that the labeling indications will inform against risk, but I am highly concerned that would not be the case in clinical practice, regardless of what it says in the label." Because of that, he advised that the contraindication include ever-smokers as well as current smokers.
Acting committee chair Robert J. Smith, MD, an endocrinologist at Brown University, Providence, Rhode Island, raised the concern that MannKind had not done a study in which Afrezza was added to basal insulin in type 2 patients, whereas basal insulin is typically introduced first in clinical practice.
Nonetheless, he also voted yes for both type 1 and type 2 patients. "Perhaps the strongest motivation for me is that an inhaled form of insulin represents a drug that will serve some patients who are not effectively served by currently available forms of insulin. I am convinced enough by the efficacy data to believe that there are at least some subgroups of patients that will substantially benefit."
However, Dr. Smith added, "I think it's quite possible that there are other subgroups, and perhaps even a majority of type 1 diabetes patients, who would do better in terms of glucose control on injected rather than this form of insulin."
He also said he voted yes because "the data about potentially serious adverse events are not strong enough that I feel it's imperative to resolve those questions before the drug might be marketed, but I think there are a number of potential concerns about adverse effects that are very, very important to follow up postmarket."
FDA advisory panel members are vetted for conflicts of interest and are given temporary waivers for participation if necessary. No waivers were issued for this meeting
Source:
Tanveer Hussain MS, IRPH
Clinical Pharmacist, VA HVHCS
Castle Point, NY
Friday, March 28, 2014
Unease Grows Among U.S. Doctors Over Indian Drug Quality
India supplies about 40% of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.
In recent months, the FDA, citing quality control problems ranging from data manipulation to sanitation, has banned the importation of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and, most recently, Sun Pharmaceutical Industries Ltd.
"I'm just beginning to realize the gravity of the problem," said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic. "It's terrible and it is starting to get a lot of traction among physicians."
For full article please follow link...
For full article please follow link...
Source:
Tanveer Hussain MS, RPhI
Clinical Pharmacist @ VA HVHCS, Castle Point, NY
Chairman, Pakistani American Pharmacists Association, NY, USA
Chairman, Pakistani American Pharmacists Association, NY, USA
By Toni Clarke and Bill Berkrot, March 19, 2014 Editors' Recommendations, Reuters Health Information
Saturday, March 22, 2014
How to Overcome Sadness and Depression?
Sadness is a totally natural emotional
response to certain environmental stimuli. Most of us have support, or systems
in place to overcome depression, reach balance, and go on to be happy as
quickly as possible. But some people don’t have that support or environment. I have found that there are two groups of people
who suffer from prolonged sadness or depression. One group consists of those
that have a severe chemical imbalance, which really requires a doctor/ medical
help, and possibly medication to treat. And other are those people who lack the tools,
know how, and support systems to bounce them back from depression and sadness.
This article is written for those who don’t have severe medical condition or
severe chemical imbalance.
In my opinion, being a doctor, the latter
group of people are wise to seek natural treatments instead of simply medicating
the symptoms. That's why I am going to show you about how to decrease or
overcome sadness, without the happy pills. Below are some suggestions.
Gratitude
Sit down and make a list of 10 things
you're grateful for right now (and I dare you not to feel better). Many times
when we complain we can cause ourselves to be sad. Complaining is just a factor
of not taking into account what we're grateful for.
Set
Goals
Something special happens the moment the
paper meets the pen and we write down our main goals. Our brain chemistry
changes, and we start thinking about how we can achieve those goals.
Sleep
Getting the right amount of sleep is
healthy for our body and mind. Some argue that sleep deprivation treats
depression, but I don't agree with this, personally. Get enough rest every day.
Exercise
Try one hour of cardio (or as much as you
can) each day. If you're tee-shirt is soaking wet, you're standing in a puddle
of your own sweat, and you can feel the endorphins pumping through your body,
you did it right. Shower up and try to be happy, I dare you.
Let
go
Many times we're making ourselves sad for
no good reason at all. People have been known to keep grudges for lifetimes. When
you forgive, you remove this weight off your shoulders and put yourself in a
position to be happier.
Sunlight
Certain people have “Idiopathic sadness
disorder”, due to a lack of sunlight, they experience seasonal sadness
(Seasonal Affective Disorder). We all sometimes affected by this in the winter
when the days are shorter.
Good
Communication
It's not hard to make friends if you put
the time in. Everyone wants to be heard, appreciated, and loved. Start off by
listening, appreciating and loving, and it will come back your way.
Reading
Self-help Books
Take a temporary leave from reality and
bury yourself in one of your favourite books. A lot of wise people have been
through what you're going through and they made it through to the other side to
tell about it.
Dr. Imtiaz Syed
M.B, B.S, MBA, CRA, PCQI, CPC
LinkedIn:
http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
OpenDoor Team member. www. OpenDoor.cc
Redditch, Gloucestershire. UK.
Thursday, March 20, 2014
Health Tips
How to wash your hands.(It's generally best to wash your hands with soap and water)
1. Wet your hands with running water.
2. Apply liquid, bar soap.
3. Lather well.
4. Rub your hands vigorously for at least 20 seconds. Remember to scrub all surfaces, including the backs of your hands, wrists, between your fingers and under your fingernails.
5. Rinse well.
6. Dry your hands with a clean or disposable towel or air dryer.
Keep in mind that antibacterial soap is no more effective at killing germs than is regular soap. Using antibacterial soap may even lead to the development of bacteria that are resistant to the product's antimicrobial agents, making it harder to kill these germs in the future.
DR I SYED, M.B, B.S, MBA, CRA, PCQI, CPC
OpenDoor Team member. www. OpenDoor.cc
Redditch, Gloucestershire. UK.
LinkedIn: http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
Monday, March 17, 2014
The Early Bird Catches The Worm.
One
question to ask every morning. What am I grateful for? You should start every
single day with an attitude of gratitude. This is probably the simplest way to
actually do that. If you ask yourself this question enough days in a row, you
will wake up feeling on top of the world every single day. As you start to view
your life and the world around you as full of things to be grateful for, you’re
going to bring more and more of that into your life. We all have lots to be
grateful for but we often get caught up in all the things that are wrong with
our lives. Hopefully this will enable you shift your focus.
Simple Ways to Change Your
Morning Routine
I
wish to give some consideration to changing up how you start your day. In
addition to power questions I encourage you to start your day in a more
peaceful, quiet way then you have in the past.
You’ll find that the impact this will have on you both physically and
mentally will quite powerful.
1.
Picture
an ideal morning.
This
is one of those rare situations where you actually can make your fantasy a
reality. Picture yourself as the morning person you want to become. What do
your mornings consist of? Are you quietly drinking your coffee? Reading a book?
Also, what’s the atmosphere like? This will help you lay the groundwork for
what will later become your morning routine.
2. Let
go.
Throw
away every misconception embedded in your mind, and start this day with a clean
ground. The only way you’ll succeed is if your mind remains open and free of
negativity.
3.
One
barrel at a time.
Take
note of what time you wake up now and when you’d like to wake up from now on.
Set your alarm for 15 to 30 minutes earlier, and once you’re comfortable
getting up at that time, set it earlier again, and again, until you’re
comfortably waking up at your new early time.
4
. Don’t
turn on the Computer/ Mobile or TV.
The
first thing you would probably be doing every single morning is turn on the
computer/ mobile or TV. Starting your brain off with so much information
overload right when you wake up can’t possibly be healthy. I would say to just
enjoy your coffee or breakfast for about twenty minutes. Turning on the TV is
one of the most insidious things you can do. The news can have such a negative
impact on you that you might not even realize it. The news is generally about
everything that’s wrong in the world and this is the first thing you become
exposed to in the morning.
5
. Reading
Spiritual books/ Soothing music.
Try
to find uplifting habits or music that has peaceful melodies. One of the best
times to listen to a self-help books or program is right when you wake up.
Think about how the effect this will have on you if you do this for about
thirty days. If you listen to inspirational/uplifting material right when you
wake up, then you will eventually condition that message into your mind and
connect it with waking up in the morning.
6.
Meditate.
One
of the most challenging things about meditating is to free you from negative thoughts.
Early in the morning your mind is in a fairly quiet state and even five to ten
minutes of deep centred relaxation/meditation can make a huge difference in
your day.
Dr.
Imtiaz Syed
M.B,
B.S, MBA, CRA, PCQI, CPC
LinkedIn:
http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
OpenDoor
Team member. www. OpenDoor.cc
Redditch,
Gloucestershire. UK.
Sunday, March 16, 2014
Health Tips
Eating for a healthy heart simply means filling your plate with fruits and vegetables, paying attention to fiber, eating fish a couple times a week and limiting unhealthy fats like saturated and trans fats, as well as salt.
DR I SYED.
M.B, B.S, MBA, CRA, PCQI, CPC
LinkedIn: http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
OpenDoor Team member. www. OpenDoor.cc
Redditch, Gloucestershire. UK.
Saturday, March 15, 2014
Health Tips
Vitamin D. We get most of our vitamin D intake, essential to absorbing calcium and boosting muscle, through sun exposure and certain foods (fatty fish, egg yolk, and fortified milk). With age, our skin is less efficient at synthesizing vitamin D, so consult your doctor/ pharmacist about supplementing your diet with fortified foods or a multivitamin, especially if you’re obese or have limited sun exposure.
DR I SYED.
M.B, B.S, MBA, CRA, PCQI, CPC
LinkedIn: http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
OpenDoor Team member. www. OpenDoor.cc
Redditch, Gloucestershire. UK.
Thursday, March 13, 2014
How to get glowing skin?
Beauty isn’t
about having designer clothes or perfect hair; it’s about being comfortable in
your own skin and being proud of your skin. For some women, this confidence is
hard to maintain when they don’t feel comfortable with their skin. Wrinkles,
crow’s feet, and sagging skin all start at the cellular level. Aging is, in
part, the result of accumulated damage to the molecules that make up our skin
cells. To get your youthful glow back following foods, packed with
antioxidants, essential fatty acids and proteins, into your diet to keep your
cells and skin looking healthy well into your golden years, below are the very
best and inexpensive ways to beautify yourself and wow everyone around you!
Your friends will all wonder what your secrets are!
“To be beautiful is the birth right of every woman."
“To be beautiful is the birth right of every woman."
1. Water
Is essential for life yet most of us don't
drink nearly enough. Water is important for the health of every cell and organ
in the human body, skin included. This can be easily seen in dehydrated
individuals, who tend to have less elastic, more wrinkle prone and dull skin.
By drinking enough water, your skin will transform to be more vibrant, elastic
and healthy all-around.
2. Break Off
Your Relationship With Sugar
If you’re
looking to smooth out your skin and prevent the signs of aging, you need to
break relationship with sugar. Wrinkling and accelerated aging occurs with high
insulin and sugar intake because of an increase in abnormal attachment of sugar
molecules to the collagen (a process called glycation) and an increase in free
radical stress.
3. Get Indulge
With olive Oil & Vegetables
One
interesting study looked at the relationship between foods and wrinkling,
particularly how food can affect skin damage. Researchers and Scientists found
that participants with a higher intake of vegetables, olive oil,
monounsaturated fat and legumes had less skin wrinkling than their counterparts
who consumed milk/milk products, butter, and margarine and sugar products.
Enjoy at least one tablespoon of extra virgin olive oil daily, and be sure to
add a little colour to your plate with a wide assortment of seasonal veggies.
4. Fatty Fish
For Fewer Wrinkles
Fresh, wild
salmon is high in essential fatty acids and natural anti-inflammatory compounds
which help to keep our skin smooth and supple. Fish oil has been found to be
effective in reducing wrinkle formation and thinning of the skin by boosting
collagen and elastin levels.
5.
Beautify Your Skin With Berries
Anything
that reduces oxidative stress in the body can also help you turn back the clock
and reduce your risk of various diseases. Strawberries have been proven to help
with just that by improving the antioxidant capacity of blood.
6. Salad With Kale
Kale contains high amounts of antioxidants
that are necessary for skin healthy essentials like iron, lutein and vitamin A.
As a bonus, one cup of kale has only 36 calories and a whopping 5 grams of
fibre.
7. Go Red With Beets
They are a
great source of anthocyanins – a powerful antioxidant that reduces inflammation
and slows down the ageing process and helps prevent wrinkles. Beetroot is also
good for overall health.
8. Get Blushing
From Carrots
For the
ultimate anti-ageing, wrinkle-fighting boost, add vegetables high in vitamin C
like carrots in your diet which can protect and improve your skin. They are
high in beta carotene which the body converts to vitamin A. Vitamin A is one of
the most important nutrients for healthy skin. You can also make these
anti-ageing potions using veggies.
9. Charm Your
Skin With Strawberries
Mashed strawberries mixed with honey,
avocados or yoghurt can bring a healthy radiance to the skin. But you can also
use the juicy red fruit to whiten teeth. Strawberries contain malic acid, a
natural whitening agent.
Finally, once
you make changes to your diet, don't expect an overnight miracle. It takes six
weeks for new skin to emerge up to the surface, so the visible benefits from
dietary changes will take just as long.
(For persistent skin conditions, talk to your
DOCTOR/ PHARMACIST or consider seeing a dermatologist).
Source:
Dr. Imtiaz
Syed
M.B, B.S,
MBA, CRA, PCQI, CPC
OpenDoor Team
member. www. OpenDoor.cc
Redditch,
Gloucestershire. UK.
Monday, March 10, 2014
5 Easy Steps to Control Your Blood Pressure
Your Lifestyle plays an important role in
treating your high blood pressure. If you successfully control your blood
pressure with a healthy lifestyle, you may avoid, delay or reduce the need for
medication. By making easy lifestyle changes, you can lower your blood pressure
and reduce your risk of heart disease.
Watch
your waistline:
First of all, you should keep an eye on
your waistline. Carrying too much weight around your waist can put you at
greater risk of high blood pressure. Blood pressure often increases as your
weight increases. Losing just 10 pounds (4.5 kilograms) can help reduce your
blood pressure. In general, the more weight you lose, the lower your blood
pressure. Losing weight also makes any blood pressure medications you're taking
more effective.
·
Men are at risk if their
waist measurement is greater than 40 inches (102 centimeters, or cm).
·
Women are at risk if their
waist measurement is greater than 35 inches (89 cm).
·
Asian men are at risk if
their waist measurement is greater than 36 inches (91 cm).
·
Asian women are at risk if
their waist measurement is greater than 32 inches (81 cm).
Eat
a healthy diet:
1.
Eating a diet that is rich in
whole grains, fruits, vegetables and low-fat dairy products and skimps on
saturated fat and cholesterol can lower your blood pressure by up to 14 mm Hg.
2.
It isn't difficult to change
your eating habits. If you follow these below tips, you can adopt a healthy
diet:
3.
Keep a food diary. Writing down
what you eat, even for just a week, can shed surprising light on your true
eating habits. Monitor what you eat, how much, when and why.
4.
Consider boosting potassium.
Potassium can lessen the effects of sodium on blood pressure. The best source
of potassium is food, such as fruits and vegetables, rather than supplements.
Talk to your doctor about the potassium level that's best for you.
5.
Be a smart shopper. Make a
shopping list before heading to the supermarket/shop to avoid picking up junk
food.
Reduce
sodium (SALT) in your diet:
Even a small reduction in the sodium in
your diet can reduce blood pressure by 2 to 8 mm Hg. The recommendations for
reducing sodium are:
·
Limit sodium to 2,300
milligrams (mg) a day or less.
·
A lower sodium level — 1,500 mg
a day or less — is appropriate for people 51 years of age or older, and
individuals of any age who are African-American or who have high blood
pressure, diabetes or chronic kidney disease.
To decrease sodium in your daily diet,
consider following tips:
1.
Keep a food diary to estimate
how much sodium is in what you eat and drink each day.
2.
Read food labels. If possible,
choose low-sodium alternatives of the foods and beverages you normally buy.
3.
Eat fewer processed foods.
Potato chips, frozen dinners, and processed lunch meats are high in sodium.
4.
Don't add salt. Just 1 level teaspoon of
salt has 2,300 mg of sodium. Use herbs or spices, rather than salt, to add more
flavour to your foods.
5.
Ease into it. If you don't feel
like you can drastically reduce the sodium in your diet suddenly, cut back
gradually. Your palate will adjust over time.
Exercise
regularly:
Regular physical activity for at least 30
to 60 minutes most days of the week can lower your blood pressure by 4 to 9 millimeters of mercury (mm Hg). And it doesn't take long to see a difference.
If you haven't been active, increasing your exercise level can lower your blood
pressure within just a few weeks.
Talk to your
doctor about developing an exercise program. Your doctor can help determine
whether you need any exercise restrictions. Even moderate activity for 10
minutes at a time, such as walking and light strength training, can help.
REMEMBER; ALWAYS CONSULT YOUR DOCTOR OR PHARMACIST
BEFORE TAKIG ANY TABLET OR MEDICINE. (For any persistent conditions, talk to
your DOCTOR/ PHARMACIST at once)
Source:
Dr. Imtiaz Syed
M.B, B.S, MBA, CRA, PCQI, CPC
LinkedIn: http://uk.linkedin.com/pub/imtiaz-syed/13/89/841
OpenDoor Team member. www. OpenDoor.cc
Redditch, Gloucestershire. UK.
Subscribe to:
Posts (Atom)
