The anti-obesity medication rimonabant showed mixed results in slowing progression of coronary artery disease in patients with abdominal obesity and pre-existing coronary disease, according to a new study in the April 2 issue of JAMA. The study is being released early online April 1 to coincide with its presentation at the annual conference of the American College of Cardiology.
“Abdominal obesity, even in the absence of type 2 diabetes, is associated with a constellation of metabolic and physiological abnormalities that amplify the risk for atheroslcerotic cardiovascular disease,” the authors write in background information for the article. Atherosclerotic disease, often commonly known as “hardening” of the arteries, occurs when deposits of plaques accumulate in the inner lining of the arteries. The researchers write that there are few treatment options to address the underlying cause of the metabolic syndrome – abdominal obesity. One promising approach is the use of the selective cannabinoid type 1 receptor antagonist rimonabant. Rimonabant has not been approved by the U.S. Food and Drug Administration, but is available in several other countries. Metabolic syndrome includes high triglyceride levels, a low HDL (good) cholesterol level, high blood pressure, and a high level of glucose (sugar) in the blood.
Europe’s drugs regulators will take another look at GlaxoSmithKline Plc’s new breast cancer pill Tyverb after new data showed a small risk of higher liver enzymes during treatment with the drug.
GSK, Europe’s biggest drug maker, said on Tuesday that the European Commission had referred Tyverb, which is on sale in the United States under the name Tykerb, back to the EU’s Committee for Medicinal Products for Human Use (CHMP).
CHMP recommended conditional approval for Tyverb in December, meaning it could go on sale but that additional data were required.
Members of a study team led by Dr. Thomas Platts-Mills of the University of Virginia Health System knew they had a medical mystery on their hands. When treated with the widely-used cancer drug, cetuximab, patients in several states – mostly in the Southeast – were experiencing allergic reactions more frequently and more severely than those living elsewhere. Reactions typically occurred during initial treatment and sometimes included anaphylaxis, a life-threatening condition characterized by a rapid drop in blood pressure, fainting, difficulty breathing, and wheezing.
Previous research had shown that 22 percent of patients in Tennessee and North Carolina had severe allergic reactions to the drug. Even higher reaction rates and clusters of cases had been reported in Arkansas, Missouri and Virginia. This data contrasted sharply with the drug’s label, which states that three percent of patients experienced severe allergic reactions, and with results in the northeast, where less than one percent of patients receiving cetuximab had allergic reactions.
“There seemed to be a link between geographic location and allergic response, and we wanted to know why,” explains Dr. Thomas Platts-Mills, Professor of Medicine, Allergy and Clinical Immunology at UVA. The team’s findings, published in the March 13, 2008 edition of the New England Journal of Medicine, offer a key clue to solving this mystery.
A new class of painkillers that block a receptor called TRPV1 may interfere with brain functions such as learning and memory, a new study suggests. The experiments with rat brain found that the TRPV1 receptor regulates a neural mechanism called long-term depression, which is believed to be central to establishing memory pathways in the brain.
The researchers said their findings also suggest that the function of TRPV1 in neural tissue may explain reported side effects of the anti-obesity drug Acomplia, widely used outside the U.S. While Acomplia has been approved in Europe, the FDA denied U.S. approval because of concerns that the drug increases risk of depression and suicide. The researchers, led by Julie Kauer, published their findings in the March 13, 2008, issue of the journal Neuron, published by Cell Press.
TRPV1, or “transient receptor potential vanilloid 1,” is a pain receptor whose activation causes the pain in inflammation. The receptor is also triggered by noxious chemicals such as the chili pepper compound capsaicin.
Long-term use of the cancer pill Gleevec may produce fertility problems in women, Greek doctors reported on Wednesday.
Chemotherapy and radiation have long been known to damage the fertility of patients, but little is known about more targeted drugs such as Gleevec, known generically as imatinib.
Dr. Constantinos Christopoulos of the Amalia Fleming General Hospital in Athens and colleagues reported on the case of a 30-year-old woman with chronic myeloid leukemia who stopped menstruating after two years of taking Gleevec, made by Novartis Pharmaceuticals Corp.
Celebrex, an arthritis drug in the same class as the recalled painkiller Vioxx, caused irregular heartbeats in fruit flies and in heart cells taken from laboratory rats, U.S. researchers said on Friday.
“When we tried this drug on the fly heart it became clear that it gave rise to very pronounced arrhythmia,” said Dr. Satpal Singh, a pharmacologist at the State University of New York at Buffalo.
“It slows down and becomes irregular,” said Singh, whose study appears in the Journal of Biological Chemistry.
Older patients treated with the diabetes medications known as thiazolidinediones (which include rosiglitazone) had a significantly increased risk of heart attack, congestive heart failure and death, compared with the use of other hypoglycemic drugs, according to a study in the December 12 issue of JAMA. The authors suggest that these results provide further evidence that this class of medication may cause more harm than good.
The thiazolidinediones (TZDs) rosiglitazone and pioglitazone are oral hypoglycemic agents used to treat type 2 diabetes and have been shown to improve glycemic control. “While improved glycemic control has been linked to better clinical outcomes in diabetes and TZDs have been suggested as having potential cardiovascular benefits, recent concerns have arisen regarding adverse cardiac effects of these drugs,” the authors write.
Food and Drug Administration officials are pushing for a “black box” warning on GlaxoSmithKline Plc’s hard-hit diabetes drug Avandia, the Wall Street Journal reported, citing sources.
The warning would be a further blow to the top-selling diabetes drug, which came under pressure last May when a U.S. analysis linked Avandia to a 43-percent higher risk of heart attack in patients.
U.S. regulators on Thursday said warnings about the risk of sudden hearing loss linked to popular drugs for impotence, including Viagra, Cialis and Levitra, would be added to the drugs’ labels.
The U.S. Food and Drug Administration was prompted to look into a possible connection after a published report of a man taking Viagra, made by Pfizer Inc, who suffered from sudden hearing loss, a rare condition.
Eli Lilly & Co said Friday that it had won approval to market its blockbuster osteoporosis drug to post-menopausal women who are at high risk for invasive breast cancer.
The company also said U.S. health regulators had extended the use of the drug, known as Evista, to help reduce the risk of the aggressive form of breast cancer in post-menopausal women who have the bone-thinning disease.
Vioxx and related pain medications were taken off the market in 2004 because they caused dangerous heart problems in some people. A group of scientists, led by Timothy Hla at the University of Connecticut, may now have figured out how these drugs trigger these life-threatening side-effects. The new study will be published online in the The Journal of Experimental Medicine on August 27.
The target of these drugs is an enzyme called COX-2, which is produced in response to infection or injury and releases pain- and fever-inducing byproducts.
Treatment with the commonly used over-the-counter drug ibuprofen (Motrin, Advil), may reduce the impairments in thinking ability that often accompany severe liver disease, findings from an animal study suggest.
Ibuprofen is an anti-inflammatory agent that belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Previous research has suggested that inflammation plays a key role in the development of brain impairments caused by liver disease, referred to as “hepatic encephalopathy.”
wo new antidiabetes drugs are modestly effective at reducing blood glucose levels without causing weight gain in people with type 2 diabetes, according to a review in this week’s Journal of the American Medical Association.
Both drugs target incretin hormones that are produced in the gastrointestinal tract and boost the release of insulin triggered by glucose. This “incretin pathway” appears to be weakened in type 2 diabetes.
U.S. regulators on Thursday warned doctors of new risks to newborn babies, including death, associated with combining an antibiotic made by Swiss drugmaker Roche Holding AG with certain other treatments.
The U.S. Food and Drug Administration said that the injection, called Rocephin, should not be combined with calcium or calcium-containing products, following reports of an unspecified number of cases of fatal reactions in the lungs and kidneys of newborns.
Doctors are famous for sloppy scribbling — and handwritten prescriptions lead to thousands of medication errors each year. Electronics to the rescue: U.S. hospitals that switched to computerized physician order entry systems saw a 66 percent drop in prescription errors, according to a new review of studies.
Illegible handwriting and transcription errors are responsible for as much as 61 percent of medication errors in hospitals. A simple mistake such as putting the decimal point in the wrong place can have serious consequences because a patient’s dosage could be 10 times the recommended amount.