The Institute of Medicine has just released a visionary report on how we should study the safety of approved drugs.
At a December 2001 meeting with financial analysts, Merck promised to study the safety of Vioxx and a follow-up drug, Arcoxia.
The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.
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Karas , director of the center for preventative cardiology at Tufts University and who headed up the analysis, says his study actually reaffirms the safety of Lipitor, Zocor and Pravachol, known collectively as statins.
Dodd , a Democrat, is proposing a sweeping set of drug reforms that would give the Food and Drug Administration the muscle to force pharmaceutical companies to study drug safety after the medicines are approved.
The recent hullabaloo over the controversial Seralini GM maize study and questions about the safety of foods made from genetically modified crops has obscured another line of attack on biotechnology: claims that GM crops are environmentally unfriendly.
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For arthritis drugs, data is most likely to come from a Pfizer-sponsored study comparing the heart safety of Celebrex with ibuprofen and naproxen.
In fact, a recent study by the Flight Safety Foundation found that 38% of all accidents in modern turbine-powered, glass-cockpit-equipped aircraft were likely or highly likely to have been prevented if the pilot had a HUD.
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Patients are currently being recruited to the Hammersmith study so the treatment's safety and efficacy can be treated.
Dr Feher said the results of the large study "demonstrate the effectiveness and safety of chemotherapy in elderly women with metastatic breast cancer".
Certainly one would agree that the quantity and the quality of the safety data and the involvement of the FDA in the planning of the LibiGel safety study all are positive indications for LibiGel.
The 24-week safety study reported to the Conference on Retroviruses and Opportunistic Infections in Los Angeles looked at 1, 000 patients.
Without the right study, you can't know the safety of an approach.
Patients were tried on the drug before the trial started, meaning those with obvious side effects were screened out, and Crestor was so effective the study was stopped ahead of schedule, limiting the safety data.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects.
In the paper on that study, published in the journal Pharmacoepidemiology and Drug Safety, the authors claim they didn't have enough patients on Actos in their database to make a comparison.
And parents who talk on cell phones, send texts or eat and drink while driving have teenagers who are more likely to do the same, according to preliminary findings of a new safety study by Toyota Motor and the University of Michigan.
Subjects in the LibiGel safety study are a minimum of 50 years old and up to 80 years of age, and they must have at least two cardiovascular risk factors at enrollment.
Back in 1997, a study by the National Highway Traffic Safety Administration (NHTSA) found that, while the population of drivers over 70 represented 9% of all drivers, they accounted for 14% of all traffic fatalities.
The DMC has recommended FIVE times that the LibiGel safety study continue as per FDA-approved protocol, with no modifications, since there are no signals or markers that would indicate that LibiGel is less than safe.
Since Barbaro's injury, the Keeneland Association has hosted two summits on the "Welfare and Safety of the Racehorse" to study the reasons modern horses aren't racing as often as they used to.
"The NRC has repeatedly failed to enforce essential safety regulations, " wrote David Lochbaum, director of the group's Nuclear Safety Project and author of the study.
The National Patient Safety Agency (NPSA) welcomed the study and its reporting recommendations.
The study, published online Monday in the journal BMJ Quality and Safety, underscores the trade-offs in the diagnostic process: More medical tests generally improve detection, but they can also increase costs, harm patients, and produce false positives.
In 2001, the company said it would to conduct a big study testing Vioxx's heart safety, but the clinical trial never materialized.
The RECORD study is the largest clinical trial designed to evaluate the cardiovascular safety of Avandia.
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The Health and Safety Executive has commissioned a British study of MCS from the Institute of Medicine.
BBC: By BBC News Online's Environment Correspondent Alex Kirby
It doesn't stop ticking while a drugmaker does a five-year study to compare the drug, in safety and efficacy, with the alternatives.
More than 13, 000 patients have been enrolled in one study to test the drug's safety and efficacy for an application with the Food and Drug Administration.
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