Drug News
Roche says unsure why Japan warned against Tamiflu
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Swiss drugmaker Roche Holding AG said on Thursday it was unsure why the Japanese government had warned that influenza drug Tamiflu should not be given to teenagers.
No definite link had been established between Tamiflu, seen as effective against a possible pandemic triggered by bird flu, and reports of young people injured by jumping from buildings after taking the drug, Roche spokeswoman Martina Rupp said.
Tamiflu not linked with psychiatric symptoms:Roche
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Swiss drugmaker Roche Holding AG said on Tuesday new data from the United States and Japan showed there was no established causal link between neuropsychiatric symptoms and its Tamiflu influenza treatment.
Clinical studies have shown similar rates of neurologic and psychiatric events in pediatric patients being treated with Tamiflu compared to those not taking the drug.
Tamiflu side effect concerns grow after Japan deaths
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Concerns that the influenza drug Tamiflu—seen as effective against a possible pandemic triggered by bird flu—may induce fatal side effects are growing in Japan after two people who took it fell to their deaths last month.
The deaths, the latest cases of abnormal behavior by those who took Tamiflu, prompted the Health Ministry to issue a warning last week that influenza patients could show psychiatric problems, although it has denied the drug was responsible for them.
Could Viagra cure chronic pelvic pain?
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The impotence drug Viagra could help men suffering from pelvic pain. As many as one in ten men in the UK have pelvic pain syndrome, with symptoms including lower back and groin pain, and bladder problems.
A trial has been looking at the use of the drug - originally developed to help angina patients, but now widely used to treat impotence - to see if it can help to open the constricted blood vessels that may be the source of the discomfort.
First large-scale HIV vaccine trial in South Africa opens
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A large-scale clinical trial of a candidate HIV vaccine - which previously showed promise in smaller studies in the United States and elsewhere - has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.
Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.
“Smokable” pain drugs promise faster action
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All self-respecting painkillers these days offer “fast-acting relief,” a promise we accept to mean anywhere from 15 minutes to more than an hour.
For Alexza Pharmaceuticals Inc., which is developing drugs for migraine, pain, panic and agitation, “fast” has to mean “within seconds.”
Newer Class of Antidepressants Similar in Effectiveness, Side Effects Differ
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Today’s most commonly prescribed antidepressants are similar in effectiveness to each other but differ when it comes to possible side effects, according to an analysis released today by HHS’ Agency for Healthcare Research and Quality.
The findings, based on a review of nearly 300 published studies of second-generation antidepressants, show that about six in 10 adult patients get some relief from the drugs. About six in 10 also experience at least one side effect, ranging from nausea to sexual dysfunction.
Patients who don’t respond to one of the drugs often try another medication within the same class. About one in four of those patients recover, according to the review. Overall, current evidence on the drugs is insufficient for clinicians to predict which medications will work best for individual patients.
Analysis confirms ED drugs OK for diabetic men
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Viagra and similar drugs used to treat erectile dysfunction, often referred to as ED, work for men with diabetes and appear to be safe, according to a research review being published Wednesday.
Diabetes is one of the most common causes of ED, and experts estimate that diabetic men are about three times more likely than other men to deal with erection problems at some point.
Newer blood-pressure drugs pose less diabetes risk
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More recent blood pressure treatments are less likely to be associated with diabetes than are older medicines, researchers said on Friday.
Their conclusions are based on a systematic review of 22 clinical trials involving 143,000 patients who did not have diabetes when they were started on the different high blood pressure medicines.
FDA approves LIALDA™ (mesalamine)
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Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDATM(mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S. in the first quarter of 2007.
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn’s and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.
Aspirin may prevent asthma in adults: study
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Results from the Physicians Health Study indicate that regular use of aspirin may reduce the risk of “new-onset” asthma in adults by 22 percent.
However, there is no evidence that aspirin improves symptoms in people who already have asthma, and it may, of course, cause acute breathing difficulties among individuals with “aspirin-intolerant asthma.”
Drugmakers to pay for FDA review of TV ads
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Drugmakers will have to pay $6.25 million in new fees next year to help fund a U.S. Food and Drug Administration review of television commercials for their products, the agency said Thursday Pharmaceutical companies have been warned in the past about misleading claims.
The advertising plan accompanies an agreement for proposed legislation to renew industry funding for FDA drug reviews through 2012. The FDA also receives money from the federal budget.
Long-term data needed on anti-obesity drugs
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The safety and efficacy over the long term need to be documented for Xenical (known generically as orlistat), Meridia (sibutramine) and Acomplia (rimonabant) before doctors can be certain that the benefits of these anti-obesity drugs outweigh the risks, according to a commentary appearing in The Lancet medical journal.
Orlistat and sibutramine are currently approved for long-term use, while rimonabant is under review by the US Food and Drug Administration.
Orlistat reduces weight by an average of 3 kilograms, whereas sibutramine and rimonabant each reduce weight by 4 kg to 5 kg, on average, Dr. Raj S. Padwal and Dr. Sumit R. Majumdar, from the University of Alberta Hospital in Edmonton, Canada, note in their article.
U.S. approves new Pfizer obesity drug for dogs
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U.S. health officials have approved the first obesity drug aimed at treating Americans’ increasingly plump pooches, the Food and Drug Administration said on Friday.
The drug, Pfizer Inc’.s Slentrol, helps decrease appetite and fat absorption to help the roughly 5 percent of U.S. dogs that are obese lose weight, the FDA said. Another 20 percent to 30 percent are overweight, it added.
Drugs nearing approval for mysterious pain condition
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Although not all doctors are convinced that the pain and fatigue condition diagnosed as fibromyalgia is a distinct condition, drug companies are racing to win U.S. regulatory approval to serve this potentially lucrative market.
The debilitating disorder is thought to affect an estimated 2 percent to 4 percent of Americans, mainly women. Diagnosing fibromyalgia is not easy because its cause is unknown and its symptoms, which include depression, can overlap with other conditions.
