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FDA Approves Fulyzaq, First Anti-Diarrheal Drug for HIV/AIDS Patients

The U.S. Food and Drug Administration today approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract. Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification. In 2006, the FDA approved the first botanical prescription drug, Veregen (sinecatechins), a treatment for external genital and perianal warts. “Currently, there are no FDA-approved therapies for HIV-associated diarrhea,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.” Just as for other types of drugs, the safety and efficacy of a botanical drug product are established through clinical trials. In addition, manufacturers of a botanical drug product must ensure rigorous control of raw materials, and good agricultural and collection practices, together with analytical testing of the complex mixture. The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a...

FDA Approves Sirturo for Multi-Drug Resistant Tuberculosis

First drug to treat multi-drug resistant tuberculosis On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. TB is an infection caused by Mycobacterium tuberculosis and is one of the world’s deadliest diseases. It is spread from person to person through the air and usually affects the lungs, but it can also affect other parts of the body such as the brain and kidneys. According to the Centers for Disease Control and Prevention, nearly 9 million people around the world and 10,528 people in the United States became sick with TB in 2011. Multi-drug resistant TB occurs when M. tuberculosis becomes resistant to isonazid and rifampin, two powerful drugs most commonly used to treat TB. Sirturo is the first drug approved to treat multi-drug resistant TB and should be used in combination with other drugs used to treat TB. Sirturo works by inhibiting an enzyme needed by M. tuberculosis to replicate and spread throughout the body. “Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.” Sirturo is being approved under the FDA’s accelerated approval program, which allows the agency to approve a...

Exercise Testing After PCI

Recurrent ischemia and cardiac events are common after PCI and CABG, signifying that coronary artery disease may still be progressing. Guidelines from the American College of Cardiology and the American Heart Association suggest evaluating symptomatic patients after these revascularization procedures with stress imaging tests, including exercise echocardiography (ExE). Evaluating asymptomatic patients, however, is more controversial. Testing is considered inappropriate less than 2 years after PCI and less than 5 years after CABG and of indeterminate appropriateness thereafter, but the justification for these cutoffs has not been well defined in clinical research. “Careful consideration is needed before screening asymptomatic patients at any stage after revascularization.” While the presence of ischemia on an ExE can help predict adverse outcomes after PCI and CABG, there is no evidence that repeated revascularization based on positive testing can change the course of the disease or patient outcomes. When noninvasive testing is used inappropriately, it can be costly to patients and the healthcare system. It can also lead to unnecessary downstream testing and interventions, such as coronary angiography and repeat revascularization. Testing Asymptomatic Patients After PCI & CABG In the May 14, 2012 Archives of Internal Medicine, my colleagues and I examined the effectiveness of testing asymptomatic patients early and late after revascularization using data from asymptomatic patients with a history of PCI or CABG who were referred for ExE. We looked at the frequency of a positive response, the association of test results with subsequent revascularization and mortality, and the presence of any interaction of revascularization with these event rates. ExE was performed in 2,105 asymptomatic patients, 54% of whom received PCI while 46%...

FDA Approves Eliquis Anti-Clotting Drug

The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body. “Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.” The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin. Patients with prosthetic heart valves should not take Eliquis nor should patients with atrial fibrillation that is caused by a heart valve problem. These patients were not studied in clinical trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with Eliquis. There is no agent that can reverse the anti-coagulant effect of...

Disparities Persist for Rural Cancer Survivors

An analysis from Wake Forest University suggests that cancer survivors living in rural areas of the United States are at greater risk for poor health outcomes when compared with survivors from urban areas. When compared with urban survivors, rural survivors were more likely to report fair or poor health (odds ratio [OR], 1.39), psychological distress (OR, 1.23), two or more non-cancer comorbidities (OR, 1.15), and health-related unemployment (OR, 1.66). Abstract: Cancer, October 23, 2012...

Examining Serious Cardiac Arrhythmias After Stroke

A German study team has found that significant cardiac arrhythmias following an acute cerebrovascular event appear most likely to occur during the first 24 hours of care, but this risk decreases over the next 3 days. Among acute neurovascular patients admitted to a monitored stroke unit, arrhythmias were independently associated with older age and more severe neurologic deficits. Abstract: Stroke, November...

Enhancing Consultations in the ED

In EDs nationwide, consultations between emergency physicians (EPs) and other doctors or specialists for advice or intervention regarding patient care occur on a daily basis. Emergency medicine (EM) consultation is an important aspect of patient care, but few studies have analyzed the consultation process and efforts to improve communication and patient outcomes during such consultations. In most situations, consultation is not a focus of medical student or resident training, even though the importance of improving these processes is critical to patient safety and societal cost. Recent studies have shown that communication failure appears to be at the heart of most errors when patients are transitioned from ED to inpatient settings. Some investigations estimate that poor communication occurs in 14% to 24% of inpatient consultations. These events can increase direct costs to patients, pose a financial burden on the healthcare system, and result in poorer patient care and patient satisfaction. “In all fields of medicine, it’s paramount to communicate effectively with other personnel during consultations,” explains Chad Kessler, MD, MHPE. “More efforts are needed to educate physicians and consultants on effective communication techniques.” For EDs, this may lead to improved communication between physicians, fewer resources utilized in patient care, and decreased length of ED stays. Evaluating Consultation Processes In the June 2012 Journal of Emergency Medicine, Dr. Kessler and colleagues had a study published that evaluated EM consultation processes by analyzing strategies used by EPs. The study also sought to create a framework for EM consultation that can be taught and learned in the ED setting. Data from EPs were collected from informal interviews, surveys, and 1-hour group interviews to...

Bedside Tool Helps Predict Outcomes After Stroke

A clinical prediction rule for death and severe disability after acute ischemic stroke— derived from preadmission comorbidities, level of consciousness, age, and neurologic deficit—appears to identify patients who will have poor outcomes after hospitalization. In a study, investigators found that non-specialist clinicians could use scores from the rule to predict the following: 30-day mortality. Death or severe dependence at discharge. 1-year mortality. Abstract: Archives of Internal Medicine, November 12,...

Candidemia: Incidence & Antifungal Drug Resistance

During the past 20 years, adults aged 65 and older appear to have replaced infants as having the highest incidence of candidemia, according to CDC investigators. The authors noted that incidence rates declined significantly for infants during the study period. Abstract: Clinical Infectious Diseases, November 15,...

Updating Osteoarthritis Treatment Recommendations

To help clinicians manage the increasing number of patients with osteoarthritis (OA), the American College of Rheumatology (ACR) revised its guidelines for using non-pharmacologic and pharmacologic therapies in OA of the hand, hip, and knee. Published in an issue of Arthritis Care & Research, the guidelines update recommendations from 2000. According to the ACR, management of OA should begin with treatments that are beneficial and have the lowest possible risk. Prior to recommending prescription medication and surgery, low-risk modalities (eg, weight loss and exercise) should be attempted. Treatments with greater risk may be used when simpler treatments fail. Hand Osteoarthritis Potential treatment modalities for hand OA include an assessment of activities of daily living, use of assistive devices, joint protection techniques, thermal agents, and trapeziometacarpal joint splinting. Oral and topical NSAIDs, topical capsaicin, and tramadol are other treatment modalities for hand OA, but opioids and intra-articular therapies are not recommended. Topical NSAIDs are preferred to oral administration in patients aged 75 and older, thus putting an emphasis on using these agents conservatively when possible. “New therapies for OA and additional information on the safety and acceptability of existing therapies have emerged.” Knee Osteoarthritis For knee OA, aerobic or resistance land-based exercise, aquatic exercise, and weight loss are strongly recommended in the guideline update. Conditionally recommended modalities include self-management programs like manual therapy with supervised exercise, tai chi, and wedged insoles. For moderate to severe pain in patients who do not wish to undergo joint replacement, acupuncture and transcutaneous electrical nerve stimulation (TENS) are recommended. Conditionally recommended pharmacologic modalities include acetaminophen, oral and topical NSAIDs, tramadol, and intra-articular corticosteroid injections....

Managing Thromboembolism in Pregnancy

Thromboembolism is a leading cause of maternal morbidity and mortality in the United States. The risk of venous thromboembolism (VTE) is increased four-fold during pregnancy and another five-fold for 6 weeks following delivery. The increased VTE risk for these women is mainly attributed to pregnancy because it puts the body in an increased thrombogenic state, but physiologic factors, such as an enlarged uterus and compressed blood vessels at the time of childbirth, also play a role. Other risk factors include having a prior VTE, family history of thrombosis, smoking, high blood pressure, obesity, and operative delivery. The consequences of VTE during pregnancy can be severe and often stem from a failure in diagnosis rather than inadequate therapy. An updated practice bulletin from the American College of Obstetricians & Gynecologists (ACOG) was published in the September 2011 issue of Obstetrics & Gynecology to provide clinicians with updated information on the risk factors, diagnosis, management, and prevention of VTE. “This document places more emphasis on the acquired risk factors for VTE during pregnancy,” says Andra H. James, MD, who helped develop the bulletin. “The recommendations explain how to monitor women for thromboembolic events, address certain risk factors, and treat suspected or acute cases of VTE. The hope is that maternal deaths can be reduced if more clinicians adopt the recommendations provided in the bulletin.” New Recommendations to Manage VTE A major recommendation offered in the ACOG update is the use of compression ultrasonography of the proximal veins when signs or symptoms are suggestive of new onset DVT (Figure). Use of compression ultrasonography will indicate if treatment should be started or surveillance...
CVD Risk Factors & PAD

CVD Risk Factors & PAD

Smoking, hypertension, hypercholesterolemia, and type 2 diabetes appear to be the cardiovascular (CVD) risk factors mostly associated with development of clinically significant peripheral artery disease (PAD), according to results of a prospective study of nearly 45,000 United States men. At PAD diagnosis, 96% of men had at least one of these CVD risk factors. Among the findings:             Abstract: JAMA, October 24,...

Aspirin, Tumor Mutations, & Colorectal Cancer Survival

Among patients with mutated-PIK3CA colorectal cancer, regular aspirin use after their diagnosis appears to increase survival. The investigators noted, however, that survival was unchanged for those with wild-type PIK3CA colorectal cancer. Abstract: New England Journal of Medicine, October 25,...

Higher Calcium Intake Fights Off Hyperparathyroidism in Women

Increasing calcium intake in women appears to reduce the risk of hyperparathyroidism, according to researchers from New England. After 22 years of follow-up, the risk of primary hyperparathyroidism for women who took more than 500 mg/day of calcium supplements was 0.41 when compared with those who took no calcium supplements. Abstract: BMJ, October 18, 2012...

Lipid Levels Improving Nationwide

Lipid levels among adults in the United States appear to have improved between 1988 and 2010, according to a cross-sectional data analysis. Average total cholesterol decreased from 206 mg/dL to 196 mg/dL. Average LDL-cholesterol dropped by 13 mg/dL, while average HDL-cholesterol increased. Abstract: JAMA, October 17,...

Do EMRs Make Documentation Too Easy?

There are many interesting unintended consequences of electronic medical records (EMRs). I was reminded of this by a recent blog I wrote about what interns really do when they are on call. According to a study from a VA hospital using trained time-motion observers, interns spend 40% of their time on a computer and only 12% of their time taking care of patients. This meshes well with other reports noting that doctors are staring at screens instead of talking to patients. Here’s the problem. The system actually rewards extensive documentation, which may result in less patient contact. The saying “If you didn’t document it, you didn’t do it” has morphed into “Document it, and you can use a higher billing code.” Here are some billing codes for hospital visits: 99221 Initial Hospital Care, Physician spends 30 minutes at the bedside 99222 Initial Hospital Care, Physician spends 50 minutes at the bedside 99223 Initial Hospital Care, Physician spends 70 minutes at the bedside Sources tell me that they know of physicians who never bill for less than 99223 or 70 minutes for a history and physical (H&P) examination. In order to do this the doctor must document such things as having reviewed at least 10 different systems (eg, respiratory, GI, musculoskeletal etc.). This is easy to document without having actually done it. The EMR may have popup windows with lists of systems and symptoms that can be checked off as reviewed. This problem is more prevalent among the so-called “cognitive” specialties like internal medicine and primary care because for procedure-based specialties like surgery, the H&P is usually “bundled” (included) as...

FDA Approves Juxtapid for Homozygous Familial Hypercholesterolemia

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments. HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol, often called the “bad” cholesterol, from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in approximately one in one million individuals. For those with HoFH, heart attacks and death often occur before age 30. Juxtapid works by impairing the creation of the lipid particles that ultimately give rise to LDL. Juxtapid is a capsule taken once a day, without food, and at least two hours after the evening meal. Patients should take supplements that contain fat-soluble vitamins and essential fatty acids daily while taking Juxtapid. “Juxtapid, in addition to diet changes and other cholesterol-lowering treatments, is a new option for those suffering with HoFH and the serious health consequences resulting from this condition,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. The safety and effectiveness of Juxtapid were evaluated in a clinical trial of 29 patients with HoFH. On average, levels of LDL cholesterol fell by approximately one-half during the first 26 weeks among those who tolerated the drug. Juxtapid carries a Boxed Warning regarding a serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation...

FDA Approves Varizig for Reducing Chickenpox Symptoms

The U.S. Food and Drug Administration has approved Varizig for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. Varizig is a varicella zoster immune globulin preparation. Varicella zoster virus (VZV) causes chickenpox in children and shingles in adults. Varizig is the only FDA approved immune globulin for VZV after exposure available in the United States. It was designated as an orphan drug by the FDA and received a priority review. Most people in the United States have immunity to VZV from vaccination or from having had chickenpox during childhood. However, people without immunity to VZV who are exposed to the virus may experience severe infections that are sometimes fatal. People most at risk include children or adults with weakened immune systems, pregnant women, and infants exposed during pregnancy or after birth. Occasionally, healthy people without immunity to VZV may contract severe infections. Antiviral treatments are not always effective and cannot be used in some cases. “This approval fills an unmet need by providing a treatment to lower the risk of severe, potentially fatal varicella infections in vulnerable patients,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. Varizig is an antibody preparation manufactured from plasma of healthy donors with high anti-VZV antibody levels. The donated plasma comes from FDA-licensed collection facilities in the United States and Canada. Varizig is administered in two or more injections, depending on the weight of the recipient, within 96 hours after exposure. Varizig is approved for immuno-compromised children and adults, newborns, pregnant women, premature infants, children...

FDA Expands Tamiflu’s Use to Treat Children Younger than 1 Year

The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days. The drug is not approved to prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old. Tamiflu was approved in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days. It has since been approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than two days, and to prevent flu in adults and children ages 1 year and older. Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 milligrams per kilogram twice daily for five days. These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu. “Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.” Tamiflu is the only product approved to treat flu infection in children younger than...

FDA Approves Gattex to Treat Short Bowel Syndrome

The U.S. Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition). SBS is a condition that results from the partial or complete surgical removal of the small and/or large intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition. Gattex is an injection administered once daily that helps improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition. It is the third FDA-approved drug to treat adults with SBS receiving nutritional support. Zorbtive (somatropin) and Nutrestore (glutamine) were approved in 2003 and 2004, respectively. “Today’s approval expands the available treatment options for patients with this life-threatening condition,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Because Gattex may cause other serious health conditions, it is critical that patients and health care professionals understand the drug’s potential and known safety risks.” Patients treated with Gattex have a potential increased risk of developing cancer and abnormal growths (polyps) in the intestine, obstructions in the intestine, gallbladder disease, biliary tract disease and pancreatic disease. To ensure that the benefits of Gattex outweigh the potential risks, the drug is being approved with a Risk Evaluation and Mitigation Strategy, consisting of a communication plan and training for prescribers. Gattex’s safety, efficacy and tolerability were evaluated in two clinical trials and two extension studies. Patients in the trials...
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