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The Safety of the HPV Vaccine

From the U.S. Department of Health and Human Services, I’m Ted Pestorius with HHS HealthBeat.

A survey finds that a new vaccine against cervical cancer is about as safe as any other vaccine.

At the Centers for Disease Control and Prevention, Barbara Slade reviewed national health data through a database of voluntary reports on vaccines.
[Barbara Slade speaks] "For 23 million doses that were sent out, we’ve received 12,424 reports."

Of those reports, only about 6 percent were considered serious. Those include 20 verified deaths of widely varying causes, and two cases of Lou Gehrig’s disease. The researchers say they can’t tell if those resulted in some way from the vaccine. So the researchers conclude that the vaccine looks safe for the girls and young women who should get it. So far, more than 7 million have.

The study is in the Journal of the American Medical Association.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ted Pestorius.

Food and Drug Administration has approved the H1N1 Influenza Virus Vaccine additional

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Influenza A (H1N1) 2009 Monovalent

 FDA approved these vaccines as a strain change to each manufacturer’s seasonal influenza vaccine.  There is considerable experience with seasonal influenza vaccine development and production and influenza vaccines produced by this technology have a long and successful track record of safety and effectiveness in the United States.  The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the usual testing and lot release procedures that are in place for seasonal influenza vaccines.


Injectable Vaccines
Intranasal Vaccines

know more about this vaccines - click here


Alzheimer's Disease Awareness Month

Nearly 4.5 million Americans suffer from Alzheimer's disease, a brain disorder that affects memory, thinking, and reasoning skills. Early symptoms of Alzheimer's are sometimes mistaken for normal aging, so according to National Institute on Aging about the topic of Forgetfulness, you should know when to ask for help.

Diagnosis

Maria has been a teacher for 35 years. Teaching fills her life and gives her a sense of accomplishment, but recently she has begun to forget details and has become more and more disorganized. At first, she laughed it off, but her memory problems have worsened. Her family and friends have been sympathetic but are not sure what to do. Parents and school administrators are worried about Maria’s performance in the classroom. The principal has suggested she see a doctor. Maria is angry with herself and frustrated, and wonders whether these problems are signs of Alzheimer’s disease or just forgetfulness that comes with age. 

Many people worry about becoming forgetful. They think forgetfulness is the first sign of Alzheimer’s disease (AD). Over the past few years, scientists have learned a lot about memory and why some kinds of memory problems are serious but others are not.

Age-Related Changes in Memory

Forgetfulness can be a normal part of aging. As people get older, changes occur in all parts of the body, including the brain. As a result, some people may notice that it takes longer to learn new things, they don’t remember information as well as they did, or they lose things like their glasses. These usually are signs of mild forgetfulness, not serious memory problems.
Some older adults also find that they don’t do as well as younger people on complex memory or learning tests. Scientists have found, though, that given enough time, healthy older people can do as well as younger people do on these tests. In fact, as they age, healthy adults usually improve in areas of mental ability such as vocabulary.
 

Keeping Your Memory Sharp

People with some forgetfulness can use a variety of techniques that may help them stay healthy and maintain their memory and mental skills. Here are some tips that can help:
  • Plan tasks, make “to do” lists, and use memory aids like notes and calendars. Some people find they remember things better if they mentally connect them to other meaningful things, such as a familiar name, song, book, or TV show.
  • Develop interests or hobbies and stay involved in activities that can help both the mind and body.
  • Engage in physical activity and exercise. Several studies have associated exercise (such as walking) with better brain function, although more research is needed to say for sure whether exercise can help to maintain brain function or prevent or delay symptoms of Alzheimer’s.
  • Limit alcohol use. Although some studies suggest that moderate alcohol use has health benefits, heavy or binge drinking over time can cause memory loss and permanent brain damage.
  • Find activities, such as exercise or a hobby, to relieve feelings of stress, anxiety, or depression. If these feelings last for a long time, talk with your doctor.  

Other Causes of Memory Loss

Some memory problems are related to health issues that may be treatable. For example, medication side effects, vitamin B12 deficiency, chronic alcoholism, tumors or infections in the brain, or blood clots in the brain can cause memory loss or possibly dementia (see more on dementia, below). Some thyroid, kidney, or liver disorders also can lead to memory loss. A doctor should treat serious medical conditions like these as soon as possible.

Emotional problems, such as stress, anxiety, or depression, can make a person more forgetful and can be mistaken for dementia. For instance, someone who has recently retired or who is coping with the death of a spouse, relative, or friend may feel sad, lonely, worried, or bored. Trying to deal with these life changes leaves some people confused or forgetful.

The confusion and forgetfulness caused by emotions usually are temporary and go away when the feelings fade. The emotional problems can be eased by supportive friends and family, but if these feelings last for a long time, it is important to get help from a doctor or counselor. Treatment may include counseling, medication, or both.

More Serious Memory Problems

For some older people, memory problems are a sign of a serious problem, such as mild cognitive impairment or dementia. People who are worried about memory problems should see a doctor. The doctor might conduct or order a thorough physical and mental health evaluation to reach a diagnosis. Often, these evaluations are conducted by a neurologist, a specialist in problems related to the brain and central nervous system.
A complete medical exam for memory loss should review the person’s medical history, including the use of prescription and over-the-counter medicines, diet, past medical problems, and general health. A correct diagnosis depends on accurate details, so in addition to talking with the patient, the doctor might ask a family member, caregiver, or close friend for information.
Blood and urine tests can help the doctor find the cause of the memory problems or dementia. The doctor also might do tests for memory loss and test the person’s problem-solving and language abilities. A computed tomography (CT) brain scan may help rule out some causes of the memory problems.

Amnestic Mild Cognitive Impairment (MCI). Some people with memory problems have a condition called amnestic mild cognitive impairment, or amnestic MCI. People with this condition have more memory problems than normal for people their age, but their symptoms are not as severe as those of Alzheimer’s disease, and they are able to carry out their normal daily activities.
Signs of MCI include misplacing things often, forgetting to go to important events and appointments, and having trouble coming up with desired words. Family and friends may notice memory lapses, and the person with MCI may worry about losing his or her memory. These worries may prompt the person to see a doctor for diagnosis.
Researchers have found that more people with MCI than those without it go on to develop Alzheimer’s within a certain timeframe. However, not everyone who has MCI develops AD. Studies are underway to learn why some people with MCI progress to AD and others do not.
There currently is no standard treatment for MCI. Typically, the doctor will regularly monitor and test a person diagnosed with MCI to detect any changes in memory and thinking skills over time. There are no medications approved for use for MCI.

Dementia.

Dementia is the loss of thinking, memory, and reasoning skills to such an extent that it seriously affects a person’s ability to carry out daily activities. Dementia is not a disease itself but a group of symptoms caused by certain diseases or conditions such as AD. People with dementia lose their mental abilities at different rates.
Symptoms may include:
  • Being unable to remember things
  • Asking the same question or repeating the same story over and over
  • Becoming lost in familiar places
  • Being unable to follow directions
  • Getting disoriented about time, people, and places
  • Neglecting personal safety, hygiene, and nutrition
Two of the most common forms of dementia in older people are Alzheimer’s disease and vascular dementia. These types of dementia cannot be cured at present.
In Alzheimer’s disease, changes to nerve cells in certain parts of the brain result in the death of a large number of cells. Symptoms of AD begin slowly and worsen steadily as damage to nerve cells spreads throughout the brain. As time goes by, forgetfulness gives way to serious problems with thinking, judgment, recognizing family and friends, and the ability to perform daily activities like driving a car or handling money. Eventually, the person will need total care.
In vascular dementia, a series of strokes or changes in the brain’s blood supply leads to the death of brain tissue. Symptoms of vascular dementia can vary but usually begin suddenly, depending on where in the brain the strokes occurred and how severe they were. The person’s memory, language, reasoning, and coordination may be affected. Mood and personality changes are common as well.
It’s not possible to reverse damage already caused by a stroke, so it’s very important to get medical care right away if someone has signs of a stroke. It’s also important to take steps to prevent further strokes, which worsen vascular dementia symptoms. Some people have both Alzheimer’s and vascular dementia.

Treatment for Dementia

A person with dementia should be under a doctor’s care. The doctor might be a neurologist, family doctor, internist, geriatrician, or psychiatrist. He or she can treat the patient’s physical and behavioral problems (such as aggression, agitation, or wandering) and answer the many questions that the person or family may have.
People with dementia caused by Alzheimer’s disease may be treated with medications. Four medications are approved by the U.S. Food and Drug Administration to treat AD. Donepezil (Aricept®), rivastigmine (Exelon®), and galantamine (Razadyne®) are used to treat mild to moderate AD (donepezil has been approved to treat severe AD as well). Memantine (Namenda®) is used to treat moderate to severe AD. These drugs may help maintain thinking, memory, and speaking skills, and may lessen certain behavioral problems for a few months to a few years in some people. However, they don’t stop AD from progressing. Studies are underway to investigate medications to slow cognitive decline and to prevent the development of AD.
People with vascular dementia should take steps to prevent further strokes. These steps include controlling high blood pressure, monitoring and treating high blood cholesterol and diabetes, and not smoking. Studies are underway to develop medicines to reduce the severity of memory and thinking problems that come with vascular dementia. Other studies are looking at the effects of drugs to relieve certain symptoms of this type of dementia.
Family members and friends can help people in the early stages of dementia to continue their daily routines, physical activities, and social contacts. People with dementia should be kept up-to-date about the details of their lives, such as the time of day, where they live, and what is happening at home or in the world. Memory aids may help. Some families find that a big calendar, a list of daily plans, notes about simple safety measures, and written directions describing how to use common household items are useful aids.

What You Can Do

If you’re concerned that you or someone you know has a serious memory problem, talk with your doctor. He or she may be able to diagnose the problem or refer you to a specialist in neurology or geriatric psychiatry. Health care professionals who specialize in Alzheimer’s can recommend ways to manage the problem or suggest treatment or services that might help. More information is available from the organizations listed below.
People with AD, MCI, or a family history of AD, and healthy people with no memory problems and no family history of AD may be able to take part in clinical trials. Participating in clinical trials is an effective way to help in the fight against Alzheimer’s. To find out more about clinical trials, call the Alzheimer’s Disease Education and Referral (ADEAR) Center toll-free at 800-438-4380 or visit the ADEAR Center website at www.nia.nih.gov/Alzheimers. More information is available at www.ClinicalTrials.gov.

For More Information

Here are some helpful Federal and non-Federal resources:
Alzheimer’s Disease Education and Referral (ADEAR) Center
P.O. Box 8250
Silver Spring, MD 20907-8250
800-438-4380 (toll-free)
www.nia.nih.gov/Alzheimers
A service of the National Institute on Aging (NIA), the ADEAR Center offers information and publications in English and Spanish for families and caregivers on diagnosis, treatment, patient care, caregiver needs, long-term care, and research related to AD.
Alzheimer’s Association
225 North Michigan Avenue, Floor 17
Chicago, IL 60601-7633
800-272-3900 (toll-free)
866-403-3073 (TDD/toll-free)
www.alz.org
Eldercare Locator
800-677-1116 (toll-free)
www.eldercare.gov
National Library of Medicine
MedlinePlus

www.medlineplus.gov
For more information on health and aging, contact:
National Institute on Aging
Information Center

P.O. Box 8057
Gaithersburg, MD 20898-8057
800-222-2225 (toll-free)
800-222-4225 (TTY/toll-free)
www.nia.nih.gov
www.nia.nih.gov/Espanol

Visit NIHSeniorHealth (www.nihseniorhealth.gov), a senior-friendly website from the National Institute on Aging and the National Library of Medicine. This website has health information for older. Special features make it simple to use. For example, you can click on a button to have the text read out loud or to make the type larger.
National Institute on Aging
National Institutes of Health
U.S. Department of Health and Human Services
October 2008



Although there isn't yet a cure for Alzheimer's, early diagnosis can help to treat the symptoms. Learn more about Alzheimer's disease by checking out some questions and answers from the National Institutes of Health

Important Information: The Use of Expired Tamilfu for Oral Suspension Authorization

This article is based on the FDA News about authorizing the use of certain lots of expired Tamiflu for Oral Suspension as part of the federal government's response to 2009 H1N1 Influenza public health emergency in July 2009 for the use that is beyond their labeled expiration dates. FDA has now authorized a lot to ensure that the Tamiflu for Oral suspension is available for patients during public health emergency. The authorization part for the Tamiflu for Oral Suspension are part of the Strategic National Stockpile and have been tested through the federal government's Shelf-Life Extension Program also known as (SLEP).

FDA evaluates comprehensively in every testing to assure the quality and the stability of the product because FDA conducts scientific testing and analysis to dermine if certain drugs are acceptable for use beyond their expiration date, under SLEP.

So as of now this drug is authorized by the FDA for use beyond their expiration dates are not required to be relabeled with information about the use of the products beyond their expiration dates. So health care professionals and patients might receive Tamiflu for Oral Suspension that is beyond its expiration date.

For Healthcare Professionals things to consider:

  • Be aware that specific lots of Tamiflu for Oral Suspension have been authorized for use beyond their expiration dates.
  • Understand that FDA has determined that data supports the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates.
  • It is good if you discuss this information with your patients with regards to any concerns they may have about using  this product.
  • Any Tamiflu that is beyond its expiration date, you can verify it to this website in the FDA site: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm
  •  Consider discussing with patients, families, and caregivers the benefits of taking antiviral medications in relation to the potential risks of untreated illness.






Information for Patients, Families and Caregivers:
  • FDA has determined that certain lots of Tamiflu for Oral Suspension are authorized for use beyond their expiration dates based on scientific testing and analysis 
  • Discuss any concerns you have about using Tamiflu for Oral Suspension with your healthcare professionals.
  • Make sure to follow all directions given by your healthcare professional when using Tamiflu for Oral Suspension 
  • If you want to look up the lot number for your Tamiflu to see if it is authorized for use beyond its expiration date, go to http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm and look for your lot number in the table under “Tamiflu Lots Whose Expiration Date Has Been Extended”. 

Note: This contents of this article has been referred to the FDA website. 

Guidance for Industry: Helicobacter pylogi-Associated Duodenal Ulcer Diseas for Adults for develop drugs treatment

This article is only to serve as a guidance to share with you for comment purposes only and to assist sponsors in clinical drug development for treatment of adults with duodenal ulcers that is caused by the helicobacter pylogi (H. pylori) for the reduction of the duodenal ulcer recurrence. This is applicable to the development of drugs for treatment of adults with duodenal ulcers and is not addressed for treatment of children or those conditions that is associated with H. pylori, including gastric ulcers and non-ulcer dyspepsia.

There are about 95% of patients with peptic ulcer disease. Following bacterial eradication, ulcer recurrence rates have been shown to be significantly and reproducibly reduced compared to long-term acid suppressive therapy. In the year 1994, the National Institutes of Health consensus panel has recommended that "Since cure of the H.pylori  decreases ulcer recurrence and facilitates healing, antibiotic therapy is definitely indicated for all H.pylori  infected ulcer patients.

This program for development according to them that sponsors should conduct at least two adequate and well-controlled trials for purpose of establish safety and efficacy of antimicrobial-containing regiments to treat the H.pylori-associated duodenal ulcer disease. 

To know more about the specific efficacy trial considerations, the study design, efficacy endpoints, clinical pharmacology and microbiology considerations, visit

Please Note: This references are from the FDA news release updates.


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Hepatology 2009



This book is an Award winning in 2009 and is now available for free download for you.

This book is the winner of the second 25,000 Euro Amedeo Challenge Award who are Stefan Mauss, Thomas Berg, Jurgen Rockstroh, Christoph Sarrazin, Heiner Wedemeyer, et al.

What this book is about:

Hepatology is a rapidly evolving medical field that will continue to grow and maintain our excitement over the next few decades. Viral hepatitis is not unlike HIV was 10 or 15 years ago when the retrovirus began to be better understood and treatable. Today, Hepatitis B viral replication can be suppressed by potent antiviral drugs, although there are  risks regarding the emergence of resistance.  Strategies to enhance the eradication rates of HBV infection still need to be developed.  On the other hand, hepatitis C virus infection can be eradicated by treatment with pegylated interferon plus ribavirin.  However, particularly in those infected by HCV genotype 1, the sustained virologic response rates are still suboptimal.  Many new antiviral drugs, especially protease and polymerase inhibitors, are currently in preclinical and clinical development and the first data from larger clinical trials provide some optimism that the cure rates for patients with chronic hepatitis C will be enhanced with these new agents.  In other areas of hepatology like for example the hereditary and metabolic liver diseases, our knowledge is rapidly increasing and new therapeutic options are on the horizon.

This book is helpful in this rapid growing world that changes from time to time. This issue about viral hepatitis and other liver diseases are a global burden and timely information which is important for physicians, scientists, patients and other health care officials from all over the world.

This book has become an international standard and therefore can help a lot of health care providers out there. If you would like to read this book, you can download it for free here in pdf format in courtesy of Hepatologytextbook.com.

Basic Principles of Drugs

This are the Basic Principles of Drugs:

  1. Identify the five basic principles of drug action.
  2. Explain nursing assessments necessary to evaluate potential problems associated with the absorption of mediations.
  3. Describe nursing interventions that can enhance drug absorption.
  4. List three categories of drug administration and state the routes of administration for each category.
  5. Differentiate between general and selective types of drug distribution mechanisms.
  6. Name the process that inactivates drugs.
  7. Identify the meaning and significance to the nurse of the term half-life when used in relation to drug therapy.


Drugs for people suffering from migraine

Migraine is merely similar with headache, the difference is that migraine is more painful wherein you will experience visual disturbances including distorted vision, zigzag patterns or flashing lights. Symptoms of migraine includes intense aching of head, often on one side of the head only, vomiting, sensitivity to light, smell and sounds. Migraine normally last between 3 to 72 hours. It is still a subject for research if what causes migraine, but for many people suffering from it says that migraine could be a cause of stress, lack of food intake or irregular meals, overtiredness, sleepless nights, extreme emotions, environmental factors and climatic conditions.

Migraine attacks to different people. So if you suffer from this kind of very painful headache better take Midrin, or Maxalt (rizatriptan). Midrin is used to ease tension and migraine headaches. For migraine headaches, take midrin at the first sign when headache occurs as prescribed by your doctor. You will usually take one capsule every hour only as needed until headache is relieved. You should not take more than five capsules in a 12 hour period; just follow the prescription of the doctor. This kind of drug should be used only as needed and not as a usual basis.

You can also use Maxalt (rizatriptan) to treat migraines. It helps patients to relieve headaches, nausea and vomiting. If the first dosage you take will only partially relieved you, then you can take a second dose after 2 hours or as prescribed by your doctor. Do not take more than 30 milligrams in a 24 hour period. For more dosage considerations read the Patient Information Leaflet for more information.

Over the Counter and Cold Medications

The Food and Drug Administration has notified healthcare professionals and their consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying product labels for over the counter drugs for consumers for cough and cold medicines to state “do not use” in children under 4 years of age.

That is why the FDA supports the CHPA members to help the prevention and the reduction for the misuse and to better give more information to consumers about the safe and the effective use of these products for children. What is FDA has done is to continue to assess the safety and efficacy of these products and to revise its Over the Counter list of approved ingredients and amounts for these medicines. Elders, parents and caregivers should be given notice and should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to their children and should therefore is deemed important to consult their healthcare professionals first if they have any questions or concerns.

Drug therapy treatment, how can it help you?

It is important to take good care of ourselves especially when one of our family members needs drug therapy, mental illness, alcohol abuse, anxiety disorder, substance abuse. Like for instance, substance abuse can lead to mental illness and of course we care about our family, and he/she needs our help, therefore we can suggest that it is important for him to find successful drug treatment. And at that in receiving drug treatment, we have to find one that gives good service, reputable company and one where our family can receive affordable drug therapy wherein they are reliable. We can find that on Cliffside Malibu, a drug treatment center that provides one of the best services you can find.


Patients can receive different kinds of therapy, so they have to help their own selves first, involve in individual or a group therapy. Especially when a patient is experiencing depression, an affordable drug treatment can help them on the process, as it cannot obviously be resolved overnight, it takes a lot of time, effort and patience to undergo the treatment. So with this services, to undergo with the drug treatment, they can be supportive, always be there for you as you move on the process of healing yourself. And when you’re treated, you’ll become a more better person, and experience a joy that is difficult to explain.