Public health problems today is the growing antibiotic resistance

One of the world's most pressing public health problems today is the growing antibiotic resistance due to its irrational use over the years. Confirming a bacterial infection, selecting the appropriate antibiotic for the infection and educating patients about the importance of taking therapy as prescribed by physicians are considered critical in treating infectious diseases. 

Bacteria can become resistant in several ways and all of which involve changes in their genetic material or genes. These altered genes enable the bacteria to either destroy the antibiotic or block its ability to inhibit bacterial growth. The laws of natural selection suggest that all bacteria will eventually become resistant to antibiotics at some point. Repeated and improper use of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed. 

Patients too contribute to antibiotic resistance by requesting physicians to prescribe antibiotics even if they do not have a bacterial infection. Noncompliance of patients to the antibiotic treatment regimen is another contributory factor for resistance which has become a significant patient safety concern today. In India, scientific debate on antibiotic resistance has taken a serious turn in the wake of a recent controversy over a reference made in the medical journal, Lancet, regarding the superbug called New Delhi metallo-beta-lactamase 1 (NDM-1). 

The superbug is stated to be resistant to the most powerful antibiotics and the circulation of the Lancet report did hit the image of India as a destination for medical tourism and cheaper treatment facilities. Scientific community in the country did take objection to the reference of New Delhi in the name, NDM-1, as it can give a wrong impression that it originated from India. What is, however, more important now is how to bring a control on the antibiotic resistance in the country. 

And it is creditable that the Union health ministry swung into action and set up a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country and also to initiate studies documenting prescription patterns and establish a monitoring system for the same. The report has been already placed before the Drug Consultative Committee a few weeks ago. Now, DCGI decided to introduce a set of new rules to regulate the sale of antibiotics and add a separate schedule under the Schedule H of the Drugs & Cosmetics Act. 

The new Schedule, HX, is expected to be added to the D&C Act to make it compulsory for patients to carry duplicate prescriptions for buying antibiotics from the chemist shops. One copy of the prescription has to be kept by the chemists for audit up to one year. These are all highly desirable initiatives from the health ministry and not many developing countries have taken such steps to counter this new threat. What is to be seen now is how effectively and fast the health ministry and drug control machinery of the country will be enforcing these critical regulations.

Safe and Novel Laxative is launched by Anglo-French Drugs

Anglo-French Drugs & Industries has recently launched lemon flavoured exitol in syrup and granules, to manage chronic constipation. With changing life style, food habits, urbanisation and disease etc. there is discomfort in the food digestion process leading to constipation and this has been aimed to fill the gap in the market.

Exitol syrup is meant for the treatment of chronic constipation and is not only safe for children and pregnant women but also, for diabetic patients. Its lactitol content has no effect on blood glucose levels and thus is safe for diabetics. Where as the exitol granules offer the advantage of ispagula husk with lactitol monohydrate to provide greater stool volume due to its combination effect.

Anglo French Drugs & Industries being a pioneer in nutrition, is best known for introducing brands in the pharma market like beplex forte tablets, maximin forte tablets, alcrin m caps, beplex LZ caps and now, exitol syrup and exitol granules.

Latest nasal spray is launched by Aptar Pharma

Aptar Pharma has introduced the latest nasal spray under the brand name Latitude. The product was launched at the CPHI-ICSE international held at Paris early this month.

This novel side-actuated nasal spray has bagged several international patents. The results of the latest acceptance studies held in the UK and the US were also presented at the exhibition. Both patients and doctors confirm the advantages of Latitude in ergonomics and hygiene which provide this spray device with optimized handling characteristics for easier nasal spray drug delivery

The company has already carried out a series of investigations and acceptance studies with healthcare professionals to determine nasal spray user expectations and preferences before starting development of its side-actuated device. The research highlighted a need for improved ergonomics, as well as a better grip and a lower actuation force to make drug delivery more comfortable and safer, according to the information from its officials.

Aptar Pharma carried out new research in the UK in November 2009 and in the US in May 2010 involving regular nasal spray users as well as doctors which include general practitioners and ENT specialists. The results confirmed that Latitude met expectations perfectly and had the support of both patients and prescribers.

The results of the research clearly identified the major advantages of Latitude which not only has excellent ergonomics providing intuitive and constant handling characteristics. It requires only minimum effort to depress the actuator completely and letting the patient know that a full drug dose has been delivered. The results also confirm that the device is easy to use by everyone, both in patient self-administration and in third party drug administration, especially for pediatric use.

Aptargroup is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

Patients, physicians, pharmacists and other healthcare providers need to know about the potential harm these herbs can have.

Millions of people are thought to use over the counter herbal remedies but doctors have warned that just because they are 'natural' does not mean they are safe.

They added that these substances can interfere with the way conventional medicines work, making them more potent or ineffective.

Researchers writing in the Journal of the American College of Cardiology said patients should inform their doctor if they are taking any herbal preparations.

Experts from the prestigious May Clinic in Arizona, America, said that St John's Wort, typically used for mild depression and sleep problems can reduce the effect of drugs to treat heart rhythm problems and high blood pressure. It may also increase blood cholesterol levels which may contribute to heart problems.

Ginkgo biloba, taken by some to boost their immune system or 'sharpen' their attention and increase energy levels can increase the risk of bleeding in patients taking blood thinners warfarin and aspirin.

Garlic can also have the same effect when taken in large doses.

Patients taking drugs such as warfarin are already wanred to avoid a list of foods and drinks, including grapefruit juice, as it interferes with the blood thinning action of the drug.

Dr Arshad Jahangir, Professor of Medicine and Consultant Cardiologist, at the Mayo Clinic, said: "Many people have a false sense of security about these herbal products because they are seen as 'natural'.

"But 'natural' doesn't always mean they are safe. Every compound we consume has some effect on the body, which is, in essence, why people are taking these products to begin with.

"We can see the effect of some of these herb-drug interactions some of which can be life-threatening—on tests for blood clotting, liver enzymes and, with some medications, on electrocardiogram."

He said a major concern is that patients often do not tell their doctor they are taking herbal remedies as they do not think of them as medicines.

Dr Jahangir said: "These herbs have been used for centuries well before today's cardiovascular medications—and while they may have beneficial effects these need to be studied scientifically to better define their usefulness and, more importantly, identify their potential for harm when taken with medications that have proven benefit for patients with cardiovascular diseases.

"Patients, physicians, pharmacists and other healthcare providers need to know about the potential harm these herbs can have."

Proton pump inhibitors (PPIs) may reduce the benefits of aspirin in patients with coronary artery disease (CAD)

Proton pump inhibitors (PPIs) may reduce the benefits of aspirin in patients with coronary artery disease (CAD), researchers from Denmark report.

Previous research has suggested that concomitant PPI use might be responsible for the reduced aspirin efficacy seen in some patients.

“Aspirin is the mainstay of secondary antithrombotic treatment; accordingly, low-dose aspirin lowers the risk of vascular events by 32% in high-risk patients,” explain Anne-Mette Hvas (Aarhus University Hospital, Brendstrupgaardsvej) and colleagues in the journal Heart.

“However, platelet response to aspirin is variable and in some patients platelet aggregation is inhibited less than expected and these patients might be at an increased risk of cardiovascular events.”

PPIs exert their antacid effect by inhibiting an ATPase associated with gastric parietal cells and raising intragastric pH, which can greatly reduce the lipophilicity of aspirin and, therefore, potentially its efficacy.

To better understand the effects of PPIs on aspirin function, the investigators studied 418 patients with stable CAD, all of whom were taking aspirin 75 mg/day and 54 of whom were also taking PPIs.

Analysis revealed that platelet aggregation was significantly greater in patients taking aspirin as well as a PPI (180 units/min) than in those taking aspirin only (152 units/min).

Platelet activation, as assessed by levels of soluble serum P-selectin, was also significantly increased in those taking both aspirin and a PPI (88.5 ng/ml) than those taking aspirin only (75.4 ng/ml).

Importantly, these differences were not explained by differences in age, sex, body mass index, blood pressure, family history of ischemic heart disease, smoking, or diabetes, all of which factors were well balanced between patient groups.

Although the authors did not demonstrate a causal link between PPI use and reduced aspirin function, “these findings may nevertheless affect the clinical practice of antithrombotic treatment,” conclude the researchers.

“In view of the widespread use of PPIs, a randomised double-blind crossover study is needed to explore further the inhibitory effect of PPIs on aspirin,” the investigators recommend.

Patients with upper gastrointestinal (GI) complaints visit their general practitioner (GP) more often

Patients with upper gastrointestinal (GI) complaints visit their general practitioner (GP) more often than patients with other conditions. Researchers writing in the open access journal BMC Family Practice found that people with dyspepsia, heartburn, epigastric discomfort and other upper-abdominal complaints had almost twice as many GP contacts, which were ultimately associated with problems in all organ systems. These patients were twice as frequently referred to specialist care and received twice as many prescriptions.

Henk van Weert led a team of researchers from the University of Amsterdam who set out to investigate the connection between psychological conditions and upper-GI symptoms. He said, "Traditionally, psychological factors were held responsible for upper-GI symptoms. With the identification of Helicobacter pylori the etiological paradigm changed dramatically, but eradication therapy has proved to be of only limited value in functional dyspepsia. We aimed to investigate whether psychological and social problems are more frequent in patients with upper GI symptoms".

The researchers found that the prevalence of upper-GI symptoms was actually associated with a broader pattern of illness-related health care use - GI patients' increased health care demands were not restricted to psychosocial problems, but comprised all organ systems. According to van Weert, "Patients with upper-GI symptoms visited their GP twice as often and received up to double the number of prescriptions as control patients. We demonstrated that not psychological and social co-morbidity, but high contact frequency in general is most strongly associated with upper-GI symptoms".

Speculating as to the reason for the increased care-seeking among people with upper-GI symptoms, van Weert said, "Patients who consult their GP frequently because of their coping style and attentiveness to physical symptoms may just have a high chance to be diagnosed in any health domain, including the psychosocial. In other words, upper GI symptoms and psychosocial complaints may both be manifestations of increased health care demands and not etiologically related".

H2 Blocker drugs Deemed Safe For Fetuses

H2 Blocker drugs, such as Famotidine, Cimetidine and Ranitidine, approved in the U.S. for acid reflux (heartburn), pose no significant risks for the fetus according to a large collaborative cohort study by researchers at Ben-Gurion University of the Negev.

The study published in the Journal of Clinical Pharmacology provides significant reassurance for the safety of the fetus when H2 blocker drugs are given to women to relieve acid reflux during pregnancy.

H2 blockers are among the most frequently recommended drugs for acid reflux symptoms of heartburn, regurgitation and trouble swallowing, which are common in pregnant women. The findings of a large cohort study examining infants born to mothers who were exposed to H2 blockers, particularly Famotidine, during pregnancy. Usually symptoms of acid reflux are more frequent and more severe in the latter months of gestation. It has been estimated that between 30 percent to 80 percent of pregnant women are affected.

The study was a collaboration between Ben-Gurion University of the Negev, Soroka University Medical Center and Clalit Health Services - all in Beer-Sheva, Israel - along with the Division of Pharmacology, Hospital for Sick Children in Toronto, Canada. It was part of the doctoral thesis of Ilan Matok under the supervision of principal investigators epidemiologist Dr. Amalia Levy and pediatrician and clinical pharmacologist professor emeritus Rafael Gorodischer. The study was conducted by the three Israeli entities as part of the BeMORE collaboration (Ben-Gurion MotheRisk Obstetric Registry of Exposure). The investigation of the safety of other medications commonly used off-label in pregnancy is an ongoing project of BeMORE investigators in large cohorts of women in Southern Israel.

"Of the vast majority of medications approved for use, there is insufficient data from human studies to determine whether the benefits of therapy exceed the risk to the fetus," according to the pediatrician and clinical pharmacologist, principal investigator Dr. Rafael Gorodischer, professor emeritus at Ben-Gurion University of the Negev. "Medicines are approved for use only after there is sufficient scientific evidence demonstrating the drug safety and effectiveness for its intended uses."

The safety of H2 blockers used during the first trimester of pregnancy was investigated by linking a database of medications dispensed over 10 years to all women registered in Clalit Health Services in the Southern District of Israel, with databases containing maternal and infant hospital records, and with therapeutic abortion records of Soroka University Medical Center, during the same period. In the study, 1,148 (or 1.4 percent) were exposed to H2 blockers during the first trimester of pregnancy of the 84,823 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to H2 blockers during the first trimester was 5.7 percent (65 of 1,148 infants), as compared with a rate of 5.3 percent (4,400 of 83,675 infants) in the unexposed group.

According to principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "Exposure to H2 blockers among this group was not associated with significantly increased risks of major congenital malformations. The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. Also, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth".

Non-cardiac chest pain is closely related to gastroesophageal reflux diseases

It is well known that non-cardiac chest pain is closely related to gastroesophageal reflux diseases (GERD). Chest pain of esophageal origin can be difficult to distinguish from that caused by cardiac ischemia because the distal esophagus and the heart share a common afferent vagal supply, and GERD can cause episodes of non-cardiac chest pain that resemble ischemic cardiac pain.

A research team led by Dr. Yoshihisa Urita from Toho University School of Medicine investigated the association between gastroesophageal reflux diseases (GERD) and coronary heart diseases. Their study was published on April 14, 2009 in the World Journal of Gastroenterology.

One thousand nine hundred and seventy consecutive patients were enrolled in this study. All of the patients who first attend their hospital were asked to respond to the F-scale questionnaire regardless of their chief complaints. All patients had a careful history taken, and resting echocardiography (ECG) was performed by physicians if the diagnostic necessity arose. Patients with ECG signs of coronary artery ischemia were defined as ST segment depression based on the Minnesota code.

Among 712 patients (36%) with GERD, ECG was performed in 171 (24%), and ischemic changes were detected in eight (5%). Four (50%) of these patients with abnormal findings upon ECG had no chest symptoms such as chest pain, chest oppression, or palpitations. These patients (0.6%; 4/712) were thought to have non-GERD heartburn, which may be related to ischemic heart disease. Of the 281 patients who underwent ECG and did not have GERD symptoms, 20 (7%) had abnormal findings upon ECG. In patients with GERD symptoms and ECG signs of coronary artery ischemia, the prevalence of linked angina was considered to be 0.4% (8/1970 patients).

The study results suggest that an extra-esophageal condition causes GERD symptoms and that angina may be misclassified as GERD. Since patients with GERD have an increased risk of angina pectoris in the year after GERD diagnosis, physicians have to be concerned about missing clinically important CAD while evaluating patients for GERD symptoms.

GERD Nighttime Symptoms Are Prevalent, Have Negative Effects on Sleep Quality

There has been much debate about the relationship between gastroesophageal reflux disease (GERD) and sleep. Three new studies in Clinical Gastroenterology and Hepatology explore GERD's effect on sleep quality and the health-care system as well as how a widely prescribed sleeping pill may mask the disease. Clinical Gastroenterology and Hepatology is the official journal of the American Gastroenterological Association (AGA) Institute.

GERD is a commonly occurring condition in the U.S., with more than 40 percent of the population experiencing the disease. It develops when the reflux of stomach contents into the esophagus causes troublesome symptoms and/or complications. Heartburn and acid regurgitation are characteristic symptoms of this disease. Published literature estimates that approximately 75 percent of patients with heartburn experience nighttime GERD symptoms. Nocturnal acid reflux may be especially damaging because acid exposure is of longer duration and has been associated with complications of esophagitis, including Barrett's esophagus and cancer.

Study Suggests Sleeping Pill May Worsen Reflux Symptoms

The widely prescribed sleep-inducing hypnotic zolpidem (Ambien®) suppressed nocturnal arousals and awakenings in response to acid reflux events and increased the duration of each esophageal acid reflux event in healthy individuals and patients with GERD.

"As many as 15 percent to 30 percent of patients with disturbed sleep may have undiagnosed GERD. If the effect of blunted arousals or awakenings by sleep aids is substantiated, this would suggest caution in the use of sleep aids without first considering GERD as a cause in patients with complaints of disturbed sleep," said Anthony J. DiMarino Jr., MD, of Thomas Jefferson University and lead author of the study.

A total of eight controls and 16 GERD patients were enrolled in a randomized, double-blind, placebo-controlled study. They were given zolpidem or placebo on separate nights; the number of reflux events and reflux-associated arousals or awakenings was recorded.

"The drug had the effect of enabling subjects to 'sleep through' reflux events, thereby increasing nocturnal acid exposure. This suggests that hypnotic use by GERD patients could lead to increased risk for complicated disease. In fact, nocturnal reflux is the leading cause of Barrett's esophagus, a recognized cause of esophageal cancer," added Dr. DiMarino.

Researchers found that acid refluxing at night resulted in sleep arousal 89 percent of the time in participants (with and without GERD) given placebo but only 40 percent in those given zolpidem. In controls given placebo, acid reflux events lasted approximately one to two seconds; in controls given zolpidem, they lasted roughly three to 30 seconds. In GERD patients given placebo, the acid reflux events lasted about 20 to 55 seconds as compared to about four to eight minutes with zolpidem. With zolpidem, reflux events lasted approximately seven to 15 minutes when no arousal occurred and 30 to 68 seconds when an arousal was recorded.

GERD Nighttime Symptoms Are Prevalent, Have Negative Effects on Sleep Quality

Nighttime GERD symptoms interfere with patients falling and staying asleep, and result in considerable economic burden and reduction in health-related quality of life (HRQOL).

"These sleep difficulties result in substantial costs to the health-care system by increasing provider visits. There is a greater loss of productivity to the employer and poorer HRQOL to the patient," said Susan C. Bolge, PhD, of Consumer Health Sciences and corresponding author of the study. "Appropriate management of GERD must include treatment of nighttime symptoms, which affect both difficulty initiating and maintaining sleep."

Researchers obtained data from a patient-reported survey conducted in 2006 among the general U.S. population. Respondents who experienced GERD symptoms at least twice in the past month were categorized as GERD patients and were sub-classified into groups based on nighttime symptoms and sleep difficulties.

Of 11,685 survey respondents with GERD, 88.9 percent experienced nighttime symptoms, 68.3 percent sleep difficulties, 49.1 percent difficulty falling asleep and 58.3 percent difficulty staying asleep. These sleep difficulties were associated with a poorer HRQOL.

Sleep difficulties were also associated with greater use of health-care resources (0.9 additional provider visits), loss of work productivity (5.5 percent decrease) and increased impairment of daily activities (10.9 percent increase). This increased use of health-care resources and loss of work productivity contributes to increased economic burden of GERD.

Data Indicate Association between GERD and Sleep Problems

This large, population-based, cross-sectional, case-control study indicates a dose-response link between sleep problems and GERD that might be bi-directional, i.e. sleep problems may influence the development or increase the severity of GERD and GERD may influence the development or increase the severity of sleep problems.

"The interplay between sleep problems and GERD seems complex, but our finding of a link between the two cannot be dismissed. This finding may be of clinical relevance since a separate randomized controlled trial showed that sleep problems were improved after GERD therapy," said Catarina Jansson, PhD, of the Karolinska Institutet and lead author of the study. "Our finding may also explain the reduced work productivity associated with GERD."

The study was based on two large health surveys performed in the Norwegian county Nord-Trondelag from 1984 to 1986 and 1995 to 1997. GERD was assessed in the second survey, which included 65,333 participants (70 percent of the county's adult population). The 3,153 individuals who reported severe reflux symptoms constituted the cases, and the 40,210 individuals without reflux symptoms constituted the controls.

In models adjusted for age, sex, tobacco smoking, obesity and socioeconomic status, positive associations were observed between presence of insomnia, sleeplessness, problems falling asleep and risk of GERD. These associations were attenuated after further adjustments for anxiety, depression, myocardial infarction, angina pectoris, stroke and gastrointestinal symptoms, but remained statistically significant.

Nifedipine, a calcium-channel blocker increase esophageal acid exposure time

Nifedipine, a calcium-channel blocker, was shown to decrease lower esophageal sphincter pressure and increase esophageal acid exposure time, while atenolol, a b1 blocker, was shown to inhibit relaxation of the smooth muscle of the esophagus. However, the influence of these anti-hypertensive drugs on the segment of esophageal body contraction using high-resolution manometry was not fully investigated.

A research team from Japan observed esophageal body contraction using high-resolution manometry with 36 intraruminal transducers. Their study was published on February 28, 2010 in the World Journal of Gastroenterology.

Their research demonstrated that atenolol increased lower esophageal sphincter (LES) pressure and the amplitude of peristaltic contractions, in the middle and lower segments of the esophageal body. On the other hand, nifedipine decreased LES pressure and the amplitude of peristaltic contractions in the esophageal body.

Their results suggested that a regular administration of nifedipine for treatment of hypertension might be a risk factor for the future occurrence of gastro-esophageal reflux disease (GERD). Atenolol-induced alterations of esophageal motor activity might prevent the development of GERD.

More pronounced improvement in acid reflux symptoms shortly after surgery than with drug treatment

Stomach wrap operations may be more effective than acid suppression tablets in the treatment of severe acid reflux, according to a new Cochrane Systematic Review. The study shows a more pronounced improvement in symptoms shortly after surgery than with drug treatment.

Gastro-oesophageal reflux disease (GORD) is a common chronic disease in which acid reflux causes heartburn, acid regurgitation, vomiting and difficulty swallowing. GORD can be treated by changes to diet and acid suppression tablets, but in the most severe cases a surgical operation called a fundoplication can be carried out. This involves wrapping part of the stomach around the lower part of the gullet. However, it is not certain whether this procedure is more effective than medication.

The authors reviewed data from four trials, which together involved 1232 participants. Their conclusions relate to findings from follow-up up to one year after treatment. They found that fundoplication operations performed by keyhole surgery were more effective at reducing the symptoms of GORD over this timescale, but that there was little data available to indicate potential benefits over longer timescales.

"There is evidence to suggest that, at least in the short to medium term, surgery is more effective than tablets for treatment of GORD," says lead researcher Samantha Wileman of the Health Services Research Unit at the University of Aberdeen in the UK. "But surgery does carry a risk and whether this is outweighed by the benefits in the long term is still not certain."

"Previous research, prior to the development of keyhole surgery for GORD, has suggested that the benefits of surgery for GORD are not sustained over time, highlighting the importance for future keyhole fundoplication studies to include longer term follow-up," says Wileman. "We also need to know more about the clinical and cost implications of long term medication versus surgery."

A vaccine designed to prevent cervical cancer also may protect females from post-surgical recurrence

A vaccine designed to prevent cervical cancer also may protect females from post-surgical recurrence of the disease, according to researchers at the University of Alabama at Birmingham (UAB).

A new study shows that the Gardasil vaccine reduces the likelihood of human papillomavirus (HPV)-related disease recurring after teen and adult women already have had surgery to remove cancer or certain pre-cancerous changes, said Warner Huh, M.D., an associate professor in the UAB Division of Gynecologic Oncology and lead presenter on the study.

The findings were announced March 15 at the annual meeting of the Society of Gynecological Oncologists in Chicago.

The study shows that Gardasil reduces by approximately 40 percent the chances that more cancer or pre-cancerous changes will occur in the cervix, vagina and vulva up to 3.8 years after a female has surgery for one of those conditions.

Huh said the findings are important because they answer a question many women and their doctors have been asking - does an HPV vaccine help treat virus-related changes in the body after women have surgery to treat similar changes?

"Based on this study, the data is compelling and suggests it does help to treat virus-related changes," Huh said. "Knowing that Gardasil also may offer postoperative protection from recurrent disease will be crucial in follow-up care and overall health planning for teens and women."

The vaccine is approved to fight the four HPV strains believed to cause 70 percent of cervical cancers and more than 90 percent of genital warts

The study involved 17,622 women ages 15 to 26 from two clinical trials, some who were vaccinated and some who were not. Hundreds of study participants had surgery to remove cancer or certain pre-cancerous changes of the cervix, vagina and vulva and to remove genital warts.

Huh said the results are encouraging because patients treated for HPV-related disease are known to be at higher risk for contracting the same disease post-operatively. Reducing the risk and need of a secondary procedure is an important step in improving women's care, he said.

The birth control pill reduced the women's risk of death from bowel cancer by 38%

Women who take the birth control pill are more likely to live longer than women who have never taken the pill, according to a study published Friday in the British medical journal BMJ, the AP/Boston Globe reports. 

Researchers in the United Kingdom followed more than 46,000 women who took the pill and then compared the mortality rate of those women with women who did not take birth control pills. The women in the study generally took the pill for almost four years. Researchers followed the women for about 40 years, beginning in 1968.

The study found that the pill reduced the women's risk of death from bowel cancer by 38% and from other diseases by about 12%. Although the death rate among women on the pill under age 30 was slightly higher compared with the other women, the trend began to reverse by age 50. The researchers noted that they could not offer any theories about cause and effect because they only observed and compared women who took the pill with women who did not.

According to the AP/Globe, past research has found that the pill does not increase the risk of dying, and while it has the potential to protect against ovarian and endometrial cancer, it may raise the chances of breast and cervical cancer.

Indigestion tablets may trigger food allergies

Indigestion tablets may trigger food allergies, according to a study by scientists in Austria.

They carried out tests on around 300 people and found that those who took anti-acid pills were more likely to suffer an allergic reaction.

Speaking at the World Allergy Organisation congress, they said the pills may interfere with digestion.

This may cause food to enter the intestines before it is fully broken down, triggering an attack.

Allergic reaction

Professor Erika Jensen-Jarolim and colleagues at the University of Vienna gave half of the people in their study a drug call ranitidine, which acts in the same way as indigestion tablets. The remaining volunteers were given a dummy or placebo pill.

None of these people had reported any food allergies in the past.

They found that people taking the drug developed or showed signs of food allergy symptoms. None of those in the placebo group showed any such signs. Tests on mice have shown similar results.

The scientists said indigestion pills may reduce levels of gastric acid in the stomach. This acid helps the stomach to break down food before it enters the intestines.

They believe low levels of this acid may result in food entering the intestines before it is broken down.

They believe the body's immune system then tries to attack the food, triggering an allergic reaction.

The scientists said eating new types of food seemed to be particularly risky. This is because the body builds up a tolerance to food that is commonly consumed. However, problems may occur when people eat foods that they haven't had before.

'Stick to the diet you know and don't try exotic foods and don't make experiments,' said Professor Jensen-Jarolim.

Allergies to food can range from mild rashes to potentially life-threatening anaphylactic shocks.

'These findings are significant for those people at risk for a food allergy,' said Professor Jensen-Jarolim, 'since 10% of the adult population today is on antacids.'

Surprised

GlaxoSmithKline, which manufactures many leading indigestion remedies, said it would examine the findings.

However, a spokeswoman said the company did not believe there were any risks associated with taking its products.

'Our products have been through very extensive clinical trials and have been approved by all the government regulatory bodies,' she told BBC News Online.

'We are always alert to new research that comes into the market place and if that poses any potential threat to consumers, then we will look very closely at the research and act very quickly if we think we need to.

'However, many of our products have been in on the market for 20 odd years and this isn't something we have ever come across. We are very surprised by these findings.'

A novel molecule that will control not only diabetes but also prevent abnormalities in cholesterol levels - Latest Drug News

The Central Drug Research Institute (CDRI) has come up with a novel molecule that will control not only diabetes but also prevent abnormalities in cholesterol levels which lead to heart ailments in diabetics.

“Heart and kidney are the two main organs that get affected by diabetes,” said Dr Atul Kumar, a scientist at CDRI. Though kidney problems only occur after prolonged uncontrolled diabetes, heart problem arises with increase in level of triglyceride, a type of lipid. “We have got encouraging results with the molecule to control triglyceride and other lipids and hyperglycemia, the disorder of increased glucose in blood responsible for diabetes,” said Kumar. His research has found a place in December’s Nature India, one of the e-magazines of Nature Publishing Group.

“Research on the methodology of the new synthetic molecule is still on,” Kumar said. But test results on animals show a promising effect on both hyperglycemia and increased lipid levels. “We came up with this molecule by combining the structure of organic molecules known to have anti-hyperglycemic characters and anti-dyslipidemic characters.”

The synthetic molecule targets an enzyme found in body called PTP1B, which is responsible for non-activation of insulin.

Insulin, the enzyme responsible for glucose-related metabolism, is inhibited by PTP1B in Non-Insulin Dependent Diabetes (Type 2). “The PTP1B was known for some time as a target for diabetes but till now no drug was made to target it,” he said. The molecule, a polyhydroquinoline, was structured keeping in mind the enzyme so it inhibits the formation of PTP1B.

“The human body stores glucose in the form of glycogen. In Type 2 diabetes, another enzyme called glycogen phosphorylase inhibits this process of conversion of glucose to glycogen, because of which free glucose remains in blood, increasing the blood sugar level,” explained Kumar. “The new molecule also targets glycogen phosphorylase.”

Stressing the relevance of the molecule, Kumar said: “On the one hand diabetes is fast becoming an epidemic and on the other, drugs for it have been exhausted ¿ the reason why diabetics need to shift on multiple drugs.”

Source: www.drugscontrol.org

Strict label standards are in the offing for pharmaceutical products and medical devices - Latest Pharmaceutical News

Strict label standards are in the offing for pharmaceutical products and medical devices. Following this drug makers engaged in contract manufacturing for export purpose would face stringent scrutiny at the customs.

The Drug Controller General of India (DCGI) is in the process of tightening enforcement of export labeling norms, according to official sources. “We are instructing the port authorities to insist that the display of neutral code should be clear and with an English translation of the information, if it is in any other language so that it could be deciphered properly,” an official from the DCGI’s office said. The size of contract manufacturing pharma in India is pegged at about Rs 10,000 crore per annum.

The official said traders and exporters of drugs, who are not the actual manufacturers, cannot use their names under ‘manufacturer’ or ‘manufactured by’. All such cases violate provisions under Drug and Cosmetic Rules and fall under ‘spurious drugs’. After violations of norms, the DCGI had conveyed it to state drug regulators, port and zonal authorities in a letter late last year. The letter, signed by the DCGI Surinder Singh, stated, “...the matter is of serious nature, all concerned are requested to take necessary action in this regard under intimation to this directorate”.

Neutral code is a code given out to a manufacturer by the state licensing authorities that he can use in place of his name and address, which helps locate the coordinates of manufacturer. This provision of neutral code is actually an exemption to the manufacturer under Rule 94 of the Drug and Cosmetic Rules but ensures that information regarding every exported consignment can be traced back to the last detail.

“In many cases, we find that the information on the consignment is written out in a foreign language, in most cases the language of importing country. However, that creates problems for the officials at exit points who bear the responsibility of checking if the standard format of information is being displayed on the consignment. It is logical to ask for the information display in English,” the official said.

The DCGI’s office is taking up the issue with the health ministry. It may also put up a directive related to export labeling norms on its website in near future. Drug exporters engaged in contract manufacturing told that their clients abroad insist on having the label in native languages for regulatory clearances in their countries. “The English translation is not so much of a problem but the government recognizes it only if it is translated by official translators, and that causes delay”, said a Delhi-based drug exporter.

Source: www.drugscontrol.org

Use of erythropoiesis-stimulating agents is associated with an increased risk of venous thromboembolism - Latest Drug News

A study published online November 10 in the Journal of the National Cancer Institute says that use of erythropoiesis-stimulating agents is associated with an increased risk of venous thromboembolism.

Erythropoiesis-stimulating agents (i.e., erythropoietin and darbopoietin) stimulate red blood cell production and therefore were approved to reduce the number of blood transfusions required during chemotherapy; however, concerns about the risks of venous thromboembolism (the disease that includes deep vein thrombosis and pulmonary embolism) and mortality exist.

Dawn L. Hershman, M.D., of Columbia University Medical Center in New York, and colleagues analyzed the association between agent use and venous thromboembolism and overall survival in patients who were 65 years or older and diagnosed with colon, non-small cell lung, or breast cancer or diffuse large B-cell lymphoma in 1991-2002. Patients were identified in the Surveillance, Epidemiology, and End Results–Medicare database.

More patients who received an erythropoiesis-stimulating agent than patients who did not developed venous thromboembolism. Overall survival was similar in both groups. The number of patients receiving erythropoiesis-stimulating agents increased approximately 10-fold from 1991 through 2002. The rate of blood transfusion per year during the same time period, however, remained constant at 22%.

"Further efforts at monitoring use and long-term toxicity of expensive oncology drugs should be put in place to ensure that for any drug the benefits outweigh the risks in community practice," the authors write.

Source: www.drugscontrol.org

Fake tablet manufacturers are making merry as the demand for contraceptive - Latest Pharmaceutical News

If the emergency contraceptive pill you have popped to tide over an “accident” fails to provide the desired result, don’t be surprised: the market is being flooded with fake pills.

Fake tablet manufacturers are making merry as the demand for contraceptive and slimming pills across the country increased in the past few years, speakers at a workshop on Counterfeiting and Piracy said here on Friday.

“Every fifth contraceptive pill or one for weight reduction available in the market is either of sub-standard quality or fake,” said Sajan Poovayya, an advocate and chairman of the Federation of Indian Chambers of Commerce and Industry.

“When there is a huge demand for one particular type of product that product is on high risk as there are chances of it being of a lower quality or faked,” he added while speaking at the workshop organised by the Federation of Karnataka Chambers of Commerce and Industry.

According to a 2009 study, women aged between 16 and 35 are mostly the consumers of contraceptive or slimming pills, the second-most pirated products in the country.

Manufacturers of duplicate cosmetics market their wares at bus terminals in city suburbs and rural areas. About 23%-30% of cosmetics are not original.

The speakers at the workshop also pointed out that aggressive marketing strategies of manufacturers had led to an increase in demand, which in turn, encouraged fraudsters to market duplicate products.

According to YG Muralidharan, managing trustee of Consumer Rights Education and Awareness Trust, utter lack of awareness on differentiating fakes from originals among consumers has helped fraudsters.

Source: www.drugscontrol.org

NABP now lists more than 5,000 Internet drug outlets as Not Recommended - Latest Pharmaceutical News

On December 11, 2009, the National Association of Boards of Pharmacy(R) (NABP(R)) reached a bitter-sweet milestone in its ongoing review of Web sites selling prescription medications. NABP now lists more than 5,000 Internet drug outlets as Not Recommended. These sites -- 96% of the total number of sites reviewed -- have been found to be out of compliance with pharmacy laws and practice standards established in the United States to protect the public health.

"There is a common misconception that prescription medications purchased from any Web site calling itself a pharmacy are safe," says NABP President Gary A. Schnabel, RN, RPh. "Patients have grown to trust prescription medications in the US because the manufacturing and supply systems are tightly regulated to ensure safety. What many patients fail to realize, however, is that when buying medications from unknown sources online, those safeguards vanish, and the odds of getting counterfeit or substandard medication rise substantially." Of the 5,231 Internet drug outlets NABP had assessed since the May 2008 launch of its Internet drug outlet review program, 5,008 (96%) of the sites were found to be out of compliance with basic criteria for legitimate pharmacy practice and were posted as Not Recommended on the NABP Web site. Of the 5,008 sites listed as Not Recommended:

• More than 75% (4,029) dispense drugs without a valid prescription.
• More than half (2,762) accept a brief online questionnaire in place of a prescription. To be valid, and to ensure patient safety, a prescription must be based on a legitimate patient-practitioner relationship that has included a face-to-face physical examination.
• Nearly 25% (1,327) post a physical address located outside the US.
• Nearly half (2,436) do not provide any physical address. According to the World Health Organization, more than 50% of medicines purchased over the Internet from sites that conceal their physical address are counterfeit.
• Nearly half (2,216) offer foreign or unapproved drugs. Because these drugs are not subject to the quality and safety requirements of those approved for sale in the US -- or even of those approved for sale in other developed countries -- their safety and efficacy are unknown.
• Nearly 20% (956) do not have secure sites that protect patients' personal and financial information.
• Internet pharmacies listed as Recommended on the NABP Web site have been accredited by the VIPPS(R) (Verified Internet Pharmacy Practice Sites) program or, for veterinary sites, the Vet-VIPPS program. These Internet pharmacies have successfully completed NABP's rigorous 19-point criteria evaluation and on-site inspection to ensure they adhere to the highest standards for pharmacy practice and patient safety.

"Patients looking to purchase medications over the Internet would be well-advised to consider who is on the other end of the transaction," President Schnabel says. "Virtually anyone with a computer and a bank account can sign on to become an affiliate of a rogue network, set up a Web site using a template, and start selling drugs online. Bearing in mind that these affiliate network programs are behind thousands of Web sites selling prescription drugs, it follows that the operators of most Internet drug outlets have no knowledge of or concern for patient safety."

Knowledge is key to protecting the public from these high-tech drug dealers. NABP continues to research Web sites selling prescription drugs and report its findings to state and federal regulators, and to educate health care professionals and the public on the dangers of buying prescription drugs online, thereby empowering patients to make informed choices. More information is available in the Internet Pharmacies section of the NABP Web site, www.nabp.net.

Source: www.drugscontrol.org