This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data.
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.
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.
In that study, researchers looked at the data from two already completed studies, the Vioxx Gastrointestinal Outcomes Research study (VIGOR) and Celecoxib Long-Term Arthritis Safety Study (CLASS), and concluded that both drugs might slightly increase the risk of cardiac events such as heart attack and stroke.
The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.
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Porges points out that there is an FDA-mandated safety study of Copaxone in combination with Tysabri.
There are plenty of reasons to delay approval until a big safety study emerges.
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
The 24-week safety study reported to the Conference on Retroviruses and Opportunistic Infections in Los Angeles looked at 1, 000 patients.
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.
The new drug is by no means ready for the clinic, but it is about to undergo a preliminary safety study in healthy male volunteers.
Aside from the aforementioned stomach safety study, called VIGOR, Merck also did a smaller study, called 090, which compared Vioxx to a placebo over six weeks.
He points out that of 521 patients who took the drug in a safety study, 2 had forms of sleep paralysis, which can be a symptom of narcolepsy.
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On Monday, Novartis (nyse: NVS - news - people ) said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
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.
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 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.
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.
BioSante reported that with 2, 869 women enrolled and over 3, 000 women-years of exposure in it LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent.
Gary Landreth, one of the authors of Thursday's Science paper and a professor of neurosciences at Case Western Reserve University in Cleveland, said he expected to begin a safety study in 12 healthy patients next month, but there weren't any current plans for a larger clinical trial.
The drug is currently being tested following open-heart surgery and in a giant study to test its safety in hospitalized patients.
For arthritis drugs, data is most likely to come from a Pfizer-sponsored study comparing the heart safety of Celebrex with ibuprofen and naproxen.
The EPA first requested the information from Halliburton and seven other energy companies as part of a study into health and safety effects of fracking.
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.
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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Normally when a biotech says its study failed but then trumpets safety results, investors are right to think the company is toast.
In fact safety data from study 329 had already been submitted to the regulatory authorities and had been presented publicly before this document was written.
Walsh says this was the first efficacy data for Raptiva, and so long as the problem in the rheumatoid-arthritis study was effectiveness, not safety, it shouldn't worry investors focused on Raptiva's near-term approval to treat psoriasis.
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