Friday, March 29, 2013

GENERAL INFORMATION


GENERAL INFORMATION by Shamna .M

·                  People With Type 1 Diabetes at Risk of Thyroid Disease
People who have type 1 diabetes are more likely than others to develop an autoimmune thyroid condition.They will develop an underactive thyroid, a condition called Hashimoto's disease. About 10 percent of the time, the thyroid issue is an overactive thyroid, called Graves' disease. Thyroid problems are often diagnosed through routine annual blood tests and untreated thyroid problems can affect blood sugar levels in people with type 1 diabetes.  Sometimes people with type 1 diabetes gain weight from taking insulin, but unexplained weight gain can also be due to an underactive thyroid. The classic symptoms of an underactive thyroid are decreased energy, hair loss, inappropriate weight gain, feeling cold, constipation, dry skin, heavy periods and difficulty concentrating. Some of the symptoms also overlap with a diagnosis of depression. Symptoms of an overactive thyroid, which are often mistaken for other conditions, include trouble concentrating, heat intolerance, frequent bowel movements, excessive sweating, increased appetite, unexpected weight loss, restlessness, a visible lump in the throat (goiter), nervousness and irregular menstrual periods, according to the U.S. National Library of Medicine. Autoimmune thyroid disease is usually managed with a daily pill and researchers said that it's important to try to take this pill at the same time every day and to not eat for about 45 minutes after taking it.
·                  DNA Test Shows Promise in Guiding Advanced Breast Cancer Care



A preliminary study suggests that an experimental blood test could help show whether women with advanced breast cancer are responding to treatment. The test detects abnormal DNA from tumor cells circulating in the blood. And the new findings, reported in the March 14 issue of the New England Journal of Medicine, hint that it could outperform the existing blood tests at gauging some women’s response to treatment for metastatic breast cancer.

·         Study Confirms Slight Rise in Paralysis Risk after Swine Flu Shot



People who were vaccinated against the 2009 H1N1 swine flu virus had a slightly increased risk of a paralysis disorder, according to a new study, but the benefits of vaccination greatly outweighed the risks. Researchers analyzed data from 23 million people in the United States who received the vaccine during the 2009 outbreak -- the largest mass vaccination in recent U.S. history -- and found that they had a small excess risk of developing Guillain-Barre syndrome. The disorder of the nervous system results in temporary or longer-term paralysis, and sometimes causes death. The researchers found that 77 people developed Guillain-Barre syndrome up to 91 days after receiving the H1N1 vaccine. They concluded that there were 1.6 excess cases of Guillain-Barre syndrome in every 1 million people vaccinated, according to the study, which was published online March 12 in the journal The Lancet.
·                  A Cheap, Old Heart Drug May Help Elderly Heart Failure Patients



Everything old is new again, even in medicine, with a just-released study finding that an older, inexpensive drug may help keep heart failure patients out of the hospital. Largely abandoned after a 1997 study found that it did not lower heart failure patients' death rates, a re-analysis of that data found that digoxin (also known as digitalis) may lower rates of 30-day hospital readmissions by more than one-third.
·                  Drug May Ease Angina in People With Type 2 Diabetes



A new study finds that the drug Ranexa (ranolazine) may help reduce chest pain in people with type 2 diabetes. The drug is approved in the United States for treatment of chronic angina (chest pain), but this is the first study to evaluate it in patients with diabetes, heart disease and angina, according to the researchers. People with diabetes are at increased risk for heart disease, and people with heart disease and diabetes are more likely to have angina than those without diabetes, the researchers noted.
·                  Petroleum Jelly Tied to Vaginal Infection Risk in Study



A small study suggests that women who use petroleum jelly vaginally may put themselves at risk of a common infection called bacterial vaginosis. Prior studies have linked douching to ill effects, including bacterial vaginosis, and an increased risk of sexually transmitted diseases and pelvic inflammatory disease. But little research has been conducted on the possible effects of other products some women use vaginally. When the researchers tested the women for infections, they found that those who'd used petroleum jelly in the past month were more than twice as likely as non-users to have bacterial vaginosis. Bacterial vaginosis occurs when the normal balance between "good" and "bad" bacteria in the vagina is disrupted. The symptoms include discharge, pain, itching or burning -- but most women have no symptoms, and the infection usually causes no long-term problems. Still, bacterial vaginosis can make women more vulnerable to sexually transmitted diseases, including HIV. It also sometimes leads to pelvic inflammatory disease, which can cause infertility.
·                  Mini-Organ Would Mimic Pancreas to Treat Type 1 Diabetes



A new bioengineered, miniature organ dubbed the BioHub might one day offer people with type 1 diabetes freedom from their disease. In its final stages, the BioHub would mimic a pancreas and act as a home for transplanted islet cells, providing them with oxygen until they could establish their own blood supply. Islet cells contain beta cells, which are the cells that produce the hormone insulin. Insulin helps the body metabolize the carbohydrates found in foods so they can be used as fuel for the body's cells. The BioHub also would provide suppression of the immune system that would be confined to the area around the islet cells, or it's possible each islet cell might be encapsulated to protect it against the autoimmune attack that causes type 1 diabetes. The first step is to load islet cells into the BioHub and transplant it into an area of the abdomen known as the omentum. These trials are expected to begin within the next year.
·                  Drugs May Help Relieve Restless Legs Syndrome




A new review confirms that people suffering from restless legs syndrome may find some relief by taking one of several drugs approved to treat the condition, which include Requip(ropinirole), levodopaNeurontin (gabapentin) and Lyrica (pregabalin). The researchers reported that they reduce symptoms of the syndrome in more than 60 percent of patients. The first two drugs raise dopamine levels in the body, and the last two drugs reduce the amount of calcium reaching brain cells and trigger the production of other chemicals that help reduce pain. Dopamine is a brain chemical that regulates movement and mood.
·                  Researchers Describe First 'Functional Cure' of HIV in Baby




Researchers announced that a baby born two-and-a-half year ago in Mississippi with HIV is the first case of a so-called "functional cure" of the infection. Standard tests can no longer detect any traces of the AIDS-causing virus even though the child has discontinued HIV medication. The child was not part of a study but, instead, the beneficiary of an unexpected and partly unplanned sequence of events that once confirmed and replicated in a formal study might help more children who are born with HIV or who at risk of contracting HIV from their mother eradicate the virus from their body. Normally, mothers infected with HIV take antiretroviral drugs that can almost eliminate the odds of the virus being transferred to the baby. If a mother doesn't know her HIV status or hasn't been treated for other reasons, the baby is given "prophylactic" drugs at birth while awaiting the results of tests to determine his or her HIV status. This can take four to six weeks to complete. If the tests are positive, the baby starts HIV drug treatment.
The mother of the baby born in Mississippi didn't know she was HIV-positive until the time of delivery. But in this case, both the initial and confirmatory tests on the baby were able to be completed within one day, allowing the baby to be started on HIV drug treatment within the first 30 hours of life.


·                  Tattoos Can Pose Health Hazards, Doctor Warns



Allergic reaction to the tattoo pigments is one of the most common problems associated with tattooing. Infections also can pose a serious threat to health. Along with localized bacterial infections, there have been reports of people being infected with syphilis and hepatitis B and C due to non-sterile tattooing practices, Shinohara said.
Skin cancer is another potential risk associated with tattoos because they can make it hard to detect cancer-related changes in moles. If you get a tattoo, make sure it's not placed over an existing mole.
A tattoo can also cause a reaction that creates a bump that resembles a type of skin cancer called squamous cell carcinoma. Because it is hard to distinguish from skin cancer, the bump could lead to potentially unnecessary and expensive skin cancer treatment, including surgery, Shinohara said.
·                  More Evidence That Smoking Raises Breast Cancer Risk



A new research indicates that cigarette smoking appears to increase the risk of breast cancer, especially when women start smoking early in life. For years, experts have questioned whether cigarette smoking is directly linked with breast cancer risk or whether the association is complicated by the fact that many women who smoke also drink alcohol, which has also been tied to breast cancer risk. Studies have produced conflicting results. When the U.S. Surgeon General last reviewed the issue in 2004, the report concluded that there was no cause-and-effect relationship between smoking and breast cancer risk. Now, researchers analyzed data from more than 73,000 women, have found strong evidence for a link between cigarette smoking and breast cancer.
·                  No Risks to Pregnancy Seen With Morning Sickness Drug



A large new study suggests that the drug Ondansetron commonly used to treat severe cases of morning sickness does not appear to be linked to birth defects or other risks to the baby, a large new study suggests. The findings are based on records from more than 600,000 Danish women who were pregnant between 2004 and 2011. Of those women, about 0.3 percent received prescriptions for ondansetron. About half had nausea and vomiting severe enough that they had been hospitalized. The researchers found that there was no evidence that the medication increased the risks of miscarriage, stillbirth, preterm delivery or major birth defects. Of women given the morning-sickness drug in the first trimester, for example, just over 1 percent had a miscarriage, versus almost 4 percent of women who did not take the medication. And in both groups, 3 percent of moms had a baby with a major birth defect, such as a heart defect or malformations of the brain or spine, including spina bifida.
Experimental Vitiligo Treatment Shows Promise in Mice



A new study in Mice suggests that a genetically modified protein could provide the first effective treatment for the skin condition vitiligo. Vitiligo is an autoimmune disorder in which the immune system becomes overactive and kills the pigment cells that give skin its color. Researchers at the Loyola University Chicago Stritch School of Medicine developed a genetically modified protein that reversed vitiligo in mice and had similar effects on human skin tissue samples. Findings from animal studies do not always hold up in human trials, however. A protein called HSP70i plays a major role in the autoimmune response that causes vitiligo. The researchers genetically modified an amino acid in the protein in order to create a mutant version of HSP70i. This version replaces normal HSP70i and reverses the autoimmune response that causes vitiligo, the study authors explained in a Loyola news release. When the mutant HSP70i was given to mice with vitiligo, their salt-and-pepper fur turned black, giving them a normal appearance. The mutant protein had a similar effect on human skin samples, according to the study, published in the current issue of the journal Science Translational Medicine.
Blood Thinners May Boost Survival for Prostate Cancer Patients: Study



A small study suggests that men with advanced prostate cancer might live longer when they are taking blood-thinning medication. Prostate cancer patients who were also taking a blood thinner, usually to stave off a blood clot, had a 39 percent increase in overall survival over men who were not taking these drugs, report researchers from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore. But the study authors and outside experts caution that blood thinners can't be prescribed routinely to cancer patients, as they confer risks including bleeding, although men who need an anticoagulant might also find it beneficial in terms of prostate cancer. The new study included almost 250 men with advanced or spreading prostate cancer who were receiving chemotherapy. Of these, 11.7 percent were also taking a blood thinner to prevent potentially fatal blood clots that could detach and reach their lungs, known as a pulmonary embolism. The men taking blood thinners -- heparin and warfarin were included -- survived for about 21 months, compared to slightly more than 17 months for men who were not taking blood thinners. The finding was surprising, because the researchers thought venous thromboembolism would negatively affect overall survival. But how or even if the blood-thinning medications could confer a survival edge is unknown. The study only shows an association, it does not show that it's the blood thinners themselves that made the difference.

MRSA 'Super Bug' Prevalent in Nursing Homes, Study Finds



A new study of nursing homes in southern California found a drug-resistant and potentially deadly skin infection in 20 out of 22 facilities tested. Researchers say the findings point to the need for more attention to the spread of drug-resistant infections, such as community-associated strains of methicillin-resistantStaphylococcus aureus (MRSA). Community-associated strains initiate in the general outside world instead of a hospital or other health care setting. The strain of MRSA in question can lead to bloodstream infections, abscesses and pneumonia, and those in nursing homes are especially susceptible because nursing homes encourage socializing, the measures needed to combat MRSA infection may differ from those used by hospitals. In the study, published in the March issue of Infection Control and Hospital Epidemiology, researchers from University of California, Irvine, tested residents of 22 Orange County nursing homes between 2008 and 2011. At each facility, they swabbed the noses of 100 residents and as many as 100 new admissions. Of those with MRSA, one-quarter had the community-acquired strain. It was more common in nursing homes with a greater number of patients younger than 65. This may be because younger people are more active and more likely to be exposed to MRSA in places like gyms, military facilities and child-care centers. Also, the super bug was less common at admission than later on, suggesting that residents are transmitting it. The community-acquired strain of MRSA was also more common in nursing homes with more Hispanic residents. Researchers think Hispanics may be at higher risk because of factors related to their culture or their genetics. It wasn't more common among nursing homes with poorer residents.




PostCancer Chemotherapy Tied to Slight Rise in Risk for Leukemia




Chemotherapy can be a lifesaver for thousands of cancer patients, but a new study suggests that it might slightly raise the odds for a type of leukemia later in life. They have also found that over the past 30 years, the risk for acute myeloid leukemia (AML) has increased for patients who underwent chemotherapy for certain forms of cancer, particularly non-Hodgkin lymphoma. On the other hand, the researchers from the U.S. National Cancer Institute said other cancer survivors may have a reduced risk for AML due to a change in chemotherapy agents that occurred decades ago.
Vitamin D Loss Attributed to Obesity




A new study indicates that obesity can lead to vitamin D deficiency. British researchers looked at data from about 165,000 people, and found that a 10 percent rise in body-mass index (BMI) was linked with a 4 percent drop in concentrations of vitamin D in the body. BMI is a measurement of body fat based on height and weight. The investigators noted that the link between BMI and vitamin D levels was found in men and women, as well as in younger and older people. The findings suggest that a higher BMI leads to lower levels of vitamin D circulating in the body, while a lack of vitamin D has only a small effect on BMI, according to the authors of the study, published Feb. 5 in the journal PLoS Medicine.
Diabetes Drug Byetta May Offer 'Modest' Weight Loss for Very Obese Teens: Study



A small study found that the drug Byetta, approved for adults with type 2 diabetes, appears to help severely obese teens lose some weight. Researchers assigned 26 teens, ages 12 to 19, either to injections of Byetta (exenatide) or placebo injections twice daily. After three months, those who got the drug had a nearly 3 percent greater reduction in their body mass index (BMI, a measure of height versus weight) compared to those on placebo.
Calcium Supplements May Raise Men's Death Risk from Heart Disease




A new study suggests that men taking calcium supplements may be running a nearly 20 percent increased risk of dying from cardiovascular disease. Both men and women take calcium supplements to prevent bone loss. In this study of calcium intake, the risk of dying from heart disease was higher for men but not for women.
Epilepsy Drug in Pregnancy Linked to Autism Risk in Study



Women taking the epilepsy drug valproate (Depakote) while pregnant are at increased risk of having children with autism and other developmental problems, according to a small British study. Valproate is prescribed for epilepsy as well as certain psychiatric disorders and migraines. Other studies have shown its use during pregnancy is associated with birth defects and, more recently, lower IQ in school-age children. The American Academy of Neurology advises against valproate use during pregnancy, and some experts believe it should not be used by women of childbearing age.

DRUG SAFETY COMMUNICATION


Drug update By Shamna.M
DRUG SAFETY COMMUNICATION

·                  Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
The manufacturer and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.   
·                  Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas
FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics such as exenatide (ByettaBydureon),liraglutide (Victoza), sitagliptin (Januvia,JanumetJanumet XRJuvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina,KazanoOseni), and linagliptin (Tradjenta,Jentadueto). These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

DRUG RECALLS
§   Night Bullet: Undeclared Drug Ingredient
Analytical tests conducted by the FDA found that the dietary supplement product Night Bullet contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.
§   Maxiloss Weight Advanced Softgels:  Undeclared Drug Ingredient

FDA testing found that the Maxiloss Weight Advanced product to contain Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

§   Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions

U.S. Food and Drug Administration (FDA) and the manufacturer are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.
§   Vistide (Cidofovir Injection) by Gilead:  Presence of Particulate Matter
§   Triaminic, Theraflu Cough/Cold Syrups Recalled Due to Safety Cap Problems