There is reason to believe those studies wildly underestimated the actual rate of adverse events.
The first is that adverse events are easily misinterpreted and even misused for cynical purposes.
In its statement the company said the treatment had been "well tolerated with no serious adverse events".
But the drug can have side effects and cause adverse events, including heart failure, in a small minority.
This is after their UNBLINDED reviews of all adverse events including the cardiovascular events AND breast cancers reported.
Full safety data, including information on psychiatric and cardiovascular adverse events, will be presented at a later date.
Additionally, adverse events like diarrhea, hair thinning and back pain were more common in patients treated with Rebif.
Heart attack and stroke, he noted, had been listed as potential adverse events since Vioxx was approved in 1999.
Preservatives used with some glaucoma drugs can be associated with certain adverse events.
On the latter point, Healy is referring to the findings of rare but serious adverse events associated with bisphosphonates.
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To support business growth, rather than just protect against adverse events, they need better ways to assess their risk-bearing capacity.
The most common adverse events reported have been tenderness and redness where the shot was given, headache, diarrhea, and fussiness.
No device-related serious adverse events, no late vascular complications, and no significant decline in kidney function were reported at 12 months.
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Following the implant surgery, 19 of the 30 study patients experienced no adverse events related to the device or the surgery.
Giuliano said there were no serious adverse events related to the vaccine.
Figures from the Serious Hazards of Transfusion reporting scheme show a 47% increase in reporting of adverse events and near misses since 1996.
The majority of these Grade 3 or higher adverse events were chemotherapy-related and accounted for the difference between the 2 arms of the study.
Even with the formal systems in place in most of the developed world, it is difficult to quantify adverse events associated with marketed pharmaceuticals.
These folks are grilled about the data by upper management and all aspects of the program (trial design, data analysis, adverse events, etc.) are reviewed.
Adverse events could include death, hospitalization, disability and other health complications.
Thus, in addition to a wide range of other side effects, adverse events for MS drugs include the possibility of serious and even life-threatening infections.
Insurance companies assume the risk that various adverse events might happen.
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The spokesperson added that contingency plans were in place for adverse events, including agreed diversionary routes and lines of communication with the public and emergency services.
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While they can provide great comfort for patients suffering from these diseases, these drugs are known to cause adverse events like weight gain and sexual dysfunction.
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Because the drug increases the risk of liver, lung and cardiovascular adverse events, CHMP recommends that dronedarone should be used only after alternative treatments have been considered.
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Although the beneficial effects of high-potency statins have been well-characterized in clinical trials, these same trials have lacked the power to illuminate rare but potentially important adverse events.
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The initial Risperdal labeling, he says, downplayed the risk of adverse events resulting from increased prolactin levels and failed to suggest that a test should be used as well.
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The deaths had been reported to the FDA as "adverse events, " which does not mean that the product is responsible for or that it contributed to any health issue.
The manufacturer, packer or distributor of a dietary supplement is required to notify the FDA of any adverse events linked to its product, according to agency spokeswoman Tamara Ward.
Investigators monitored participants for adverse events related to the device or to the implant surgery and regularly assessed their vision for at least two years after receiving the implant.
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