Drug News
Terumo to stop selling two cardiac products in US
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A U.S.-based unit of Terumo Corp said it has entered into a consent decree with the U.S. Food and Drug Administration and agreed to stop selling two of its products used in cardiopulmonary bypass surgery.
The consent decree stems from concerns raised by the FDA about quality system procedures at Terumo Cardiovascular Systems’ manufacturing plant in Ann Arbor, Michigan.
The products that can no longer be sold are the CDI 101 Hematocrit Oxygen Saturation Monitoring System and the Tenderflow Pediatric Arterial Cannulae. Cannulae are devices inserted into the heart to facilitate blood flow during surgery.
Anti-Clotting Agent Does Not Improve Outcomes of Patients with Severe Pneumonia
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Use of the blood clot-inhibiting medication tifacogin does not appear to improve outcomes of patients with severe community-acquired pneumonia (sCAP), according to a study conducted by researchers from North and South America, Europe, Asia and Africa. The drug had shown some potential benefit in the sCAP subgroup of an earlier trial involving sepsis patients.
The findings were published online ahead of the print edition of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.
“Administration of tifacogin showed no treatment benefit in this large population of patients with severe CAP,”said Richard Wunderink, MD, professor of pulmonary and critical care medicine at Northwestern University’s Feinberg School of Medicine. “This result was consistent across a range of disease severity indices.”
Botox may quiet chronic cough
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Botox could help some people with nagging chronic coughs that haven’t responded to standard treatment, according to a new report on four patients.
Botox, or botulinum toxin type A, is perhaps best known as a wrinkle-filler, but it has medical uses including treating spastic muscles in patients with cerebral palsy and drying up excessive sweating.
The new findings suggest that Botox might also help quiet coughs, although it is not FDA-approved for this use. And the study’s authors caution that the toxin should not be seen as a “panacea.”
ED Drug Improves Heart’s Pumping Action in Young Patients with Single-Ventricle Disease
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Heart function significantly improved in children and young adults with single-ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children’s Hospital of Philadelphia.
Single-ventricle defects are a collection of cardiac malformations that impair the heart’s ability to pump blood. Examples include tricuspid atresia, pulmonary atresia/intact ventricular septum and hypoplastic left heart syndrome.
The Fontan operation is a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third surgery in a staged palliation for single-ventricle heart defects.
Sildenafil, aka Viagra, may not help vets with PTSD
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Sildenafil - marketed as Viagra—may not be much help to men who have erectile dysfunction (ED) related to post-traumatic stress disorder, a new study suggests.
Viagra is often effective for ED related to various causes—including heart disease, high blood pressure and diabetes. But studies indicate that as many of half of men who try the drug do not respond adequately.
In the new study, Iranian researchers looked at whether Viagra was helpful for combat veterans who were suffering from post-traumatic stress disorder (PTSD) as well as ED. It’s unclear how many men with PTSD suffer from sexual problems such as ED, although some studies have shown that a majority do so.
Drug helps pregnant drug users to stop smoking
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Treatment with an antidepressant drug significantly improves the mood in pregnant substance-dependent women who also smoke cigarettes, according to preliminary results reported at the 2009 Joint Conference of the Society for Research on Nicotine and Tobacco (SRNT) and SNRT-Europe.
The data also suggest that the antidepressant - bupropion—helps these women curb their smoking.
“We are encouraged by the findings given that both depression and smoking are highly prevalent in pregnant, substance-dependent patients and are associated with adverse maternal and neonatal outcomes,” said Dr. Margaret S. Chisolm, assistant professor of psychiatry at Johns Hopkins University in Baltimore, Maryland.
They call it Mellow Yellow?
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A hardline Hindu organization, known for its opposition to “corrupting” Western food imports, is planning to launch a new soft drink made from cow’s urine, often seen as sacred in parts of India.
The Rashtriya Swayamsevak Sangh (RSS), or National Volunteer Corps, said the bovine beverage is undergoing laboratory tests for the next 2 to 3 months but did not give a specific date for its commercial release.
The flavor is not yet known, but the RSS said the liquid produced by Hinduism’s revered holy cows is being mixed with products such as aloe vera and gooseberry to fight diseases such as diabetes and cancer.
Brand-Name Drugs Do Not Appear Superior to Generic Drugs for Treating Cardiovascular Diseases
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Contrary to the perception of some patients and physicians, there is no evidence that brand-name drugs are clinically superior to their generic counterparts, according to an article in the December 3 issue of JAMA, which examined studies comparing the effectiveness of generic vs. brand-name drugs for treating cardiovascular diseases.
“The problem of rising prescription drug costs has emerged as a critical policy issue, straining the budgets of patients and public/private insurers and directly contributing to adverse health outcomes by reducing adherence to important medications. The primary drivers of elevated drug costs are brand-name drugs, which are sold at high prices during a period of patent protection and market exclusivity after approval by the Food and Drug Administration (FDA),” the authors write. To control spending, many payers and clinicians have encouraged substitution of inexpensive bioequivalent generic versions of these drugs after the brand-name manufacturer’s market exclusivity period ends.
Some patients and physicians have expressed concern that generic drugs may not be equivalent in their effectiveness. “Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts. Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs,” the authors note.
Moderate Use May Avert Failure of Type 2 Diabetes Drugs
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Drugs widely used to treat type 2 diabetes may be more likely to keep working if they are used in moderation, researchers at Washington University School of Medicine in St. Louis have found in a study using an animal model.
The drugs, sulfonylureas, help type 2 diabetics make more insulin, improving control of blood sugar levels. But in most patients the effects of sulfonylureas are lost after several years of use, causing insulin secretion to shut down. This typically forces patients to switch to regular insulin injections.
“Why this happens isn’t clear yet, but we’ve found what may be cause for hope,” says senior author Colin G. Nichols, Ph.D., Carl F. Cori Professor and professor of cell biology and physiology. “We’ve shown in a mouse model that whatever causes this shutdown doesn’t kill the insulin-making beta cells of the pancreas or stop them from making insulin. Instead, it somehow stops them from secreting insulin.”
Rutgers researchers identify new antibiotic target and new antibiotic mechanism
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A team of Rutgers University scientists led by Richard H. Ebright and Eddy Arnold has identified a new antibiotic target and a new antibiotic mechanism that may enable the development of broad-spectrum antibacterial agents effective against bacterial pathogens resistant to current antibiotics. In particular, the results could lead the way to new treatments for tuberculosis (TB) that involve shorter courses of therapy and are effective against drug-resistant TB.
The researchers showed how three antibiotics – myxopyronin, corallopyronin and ripostatin – block the action of bacterial RNA polymerase (RNAP). RNAP is the enzyme that transcribes genetic information from DNA into RNA, which, in turn, directs the assembly of proteins, the building blocks of all biological systems. Blocking bacterial RNAP kills bacterial cells.
The research findings are reported in the journal Cell, published online Oct. 16 and in the Oct. 17 print issue of the journal.
Genes affect weight loss drug effectiveness
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A study conducted by researchers at Mayo Clinic shows that obese patients with specific genetic makeup had enhanced response to the weight loss drug sibutramine, while others who lack these genetic factors lost little or no weight.
The findings are published in the October issue of Gastroenterology (http://www.gastrojournal.org).
In this randomized, double-blind, placebo-controlled study, Mayo researchers measured the impact of two different dosage levels of sibutramine (10 or 15 mg daily) combined with behavioral therapy for 12 weeks in 181 overweight or obese participants. Participants received structured behavioral therapy for weight management at four, eight and 12 weeks.
No mental effects seen with Arimidex
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Women taking Arimidex to prevent breast cancer can be fairly reassured that it won’t affect their mental capacities, British researchers report.
Arimidex, a. k. a. anastrazole, belongs to a class of drugs called aromatase inhibitors, which block the production of estrogen. There have been concerns that estrogen depletion might impair cognitive abilities in women, but the results of a new study suggest that anastrazole does not have this effect in women past menopause.
“These findings should be reassuring in the short term for postmenopausal women being treated with anastrozole, their clinicians, and carers,” lead author Dr. Valerie A. Jenkins concludes.
Guide helps doctors manage vaccine allergies
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With careful monitoring, even children who have had allergic reactions to a vaccine can still be vaccinated, a U.S. team of experts said on Tuesday.
The team developed a step-by-step guide to help pediatricians quickly identify children with allergic reactions to vaccines and safely immunize them.
“We cannot reiterate enough that the vaccines used today are extremely safe, but in a handful of children certain vaccine ingredients can trigger serious allergic reactions,” said Dr. Robert Wood of Johns Hopkins Children’s Center in Baltimore, whose research appears in the journal Pediatrics.
Class of Diabetes Drugs Carries Significant Cardiovascular Risks
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A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.
“We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones.
In the editorial Singh and Furberg say, “At this time, justification for use of thiazolidinediones is very weak to non-existent.”
Medication improves alcoholics’ quality of life
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The medication topiramate may not only improve drinking problems in people with alcohol dependence, but boost their quality of life as well, according to a new study.
Topiramate (Topamax) is an anti-seizure drug that has also been shown to reduce drinking in alcoholics—possibly due to it effects on certain brain chemicals thought to be involved in alcohol dependence.
Whether treatment with the drug can also improve alcoholics’ physical and mental well-being, however, has been unclear.
