Drug Abuse
FDA warns against fake online H1N1 remedy claims
The U.S. government this week warned against the online marketing of unlicensed health remedies claiming to protect against H1N1 swine flu infection, including fake “Tamiflu” pills from India.
The Food and Drug Administration reported on Thursday that it had purchased and analyzed several products represented on the Internet as Tamiflu, Roche Holding AG’s brand name version of the antiviral drug oseltamivir.
One order, which arrived in an unmarked envelope from India, consisted of unlabeled white pills that contained talc and the common pain reliever acetaminophen, the FDA said. Others contained various amounts of oseltamivir but were not approved for use in the United States.
Row brews over ecstasy downgrade call
The government’s narcotics advisory body called on Wednesday for a cut in the penalties for using and selling the dance drug ecstasy, a recommendation the Home Office has already said it will ignore.
The 31-member Advisory Council on the Misuse of Drugs (ACMD) said in a report that ecstasy should be downgraded to a class B drug from the most serious class A category.
“After looking at all the evidence presented to us and considering the harmfulness to individuals and society alongside other drugs within the same classification, the ACMD concluded that (ecstasy) should be reclassified to a class B drug,” said the advisory council’s chairman David Nutt.
FDA lacks access to food safety records: Congress
The U.S. Food and Drug Administration lacks access to food safety tests that could have helped identify problems at a peanut plant at the center of one of the biggest food recalls in U.S. history, members of Congress said on Thursday.
The salmonella outbreak traced to a Peanut Corp. of America plant in Blakely, Georgia, has sickened more than 550 people, more than half of them children, and may be linked to eight deaths.
“We would like to have more information. There is no question,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, told a hearing of the Senate Agriculture Committee.
Man says prescription drug caused gambling problem
A former Wall Street banker who said he lost $3 million from compulsive gambling caused by a popular drug used to treat Parkinson’s disease is suing companies involved with the drug for his losses.
The lawsuit, filed in New York State Court on Tuesday, accuses the privately held German drugmaker Boehringer Ingelheim, Pfizer and Pharmacia & Upjohn of breach of warranty, negligence and negligent misrepresentation.
Randolph Simens, 55, said that he took the drug, Mirapex, from 2002 to 2007 after being diagnosed with Parkinson’s disease and suffering hand tremors.
Rash most common side effect in Vectibix trials
The most common side effect observed in ongoing trials of Amgen Inc’s cancer drug Vectibix is skin rash, according to interim analyses of pivotal trials of the drug in colorectal cancer released on Thursday.
Vectibix is already approved in the United States for treating colon cancer patients who have stopped responding to chemotherapy, and Amgen is studying the drug in earlier stages of the disease, as well as in other types of cancer.
One Phase III study of Vectibix, also known as panitumumab, is looking at its effectiveness as a first-line treatment in combination with a chemotherapy regimen known as Folfox, compared with chemo alone.
Man jailed for fake Viagra sales
The general manager of a Shanghai chemical company was jailed for two years on Thursday for selling fake tablets of the male impotence drug Viagra on the Internet, the official Xinhua news agency reported.
Program helped doctors identify OxyContin abusers
Careful monitoring of patients taking powerful but addictive pain relievers like OxyContin helped doctors identify abusers and steer them toward treatment, U.S. researchers said on Wednesday.
The key was having a standardized program applied to all patients who were getting the drugs for conditions other than cancer.
“Physicians are not very good at predicting which patients will have problems. They want to trust the patient, and unfortunately, trust does not work well in this type of treatment,” said Dr. Jennifer Meddings of the University of Michigan, who presented her findings at a meeting of the Society for General Internal Medicine in Pittsburgh.
Inhaled insulin linked to lung cancer: Pfizer
Clinical trials of the inhaled insulin product Exubera revealed an increase in the number of lung cancer patient, leading Nektar Therapeutics to end talks with potential partners to market the product, Pfizer Inc and Nektar said on Wednesday
Over the course of the clinical trials, Pfizer said 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.
Pfizer updated the Exubera labeling to include a warning with safety information about lung cancer cases found in patients who used Exubera, which U.S. regulators approved in January 2006.
Mixed results for weight loss drug on slowing progression of coronary disease
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.
EU to take another look at GSK breast cancer drug
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.
Study Offers Clues About Patient Allergies to Cancer Drug
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.
Study raises caution on new painkillers
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.
Cancer pill could affect women’s fertility - report
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 disrupts heart rhythm in fruit flies
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.
Use of Diabetes Medication by Older Adults Associated With Increased Risk of Serious Heart Problems
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.
