He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.
Bextra causes Stevens-Johnson Syndrome more often than Celebrex, a similar Pfizer pain drug, and Pfizer has been in discussions with the Food and Drug Administration about how to include the risk in the drug's label.
The FDA initially declined to approve it, asking in March 2010 for more information about the drug's prescribing label and the companies' risk-management plan to ensure the drug's benefits outweigh its risks.
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The new label adds a clearer warning regarding the risk of rare muscle-weakening side effects that can lead to kidney damage or death.
The country's Food and Drug Administration, which regulates such matters, has recently decided that if a foodstuff contains more than 6.25g of soya per serving, manufacturers can state on its label that eating soya may reduce the risk of heart disease.
Victoza's label also has a warning about the potential risk of thyroid tumors.
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Obviously, an unblinded trial design (also known as an open-label trial) represents a particularly high-risk approach when the outcome involves a subjective assessment by either the patient or the physician.
Vioxx's label now indicates the drug may carry some cardiovascular risk.
If the risk is obvious, there's no need for a warning label--hence, steak knives don't have them.
Merck finally withdrew the arthritis drug from the market and then was deluged with lawsuits claiming the label didn't warn doctors of the higher heart risk.
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After a big study in 2001 showed hints of heart risk for Vioxx, it took a year for the drug's label to be changed--and then, only a "precaution, " not a warning, was added.
The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
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The combination of little benefit and potential risk underscores the need "to set a pretty high bar" for the off-label uses of medicines, Dr. Yank said.
The fact that Bextra, given with an injectable drug, increased the risk of heart attacks following open-heart surgery will also be included in the Bextra label.
Another possible label change would warn that excessive doses of ibuprofen and naproxen may increase the risk of gastrointestinal bleeding and magnify kidney damage for those with preexisting conditions.
In order to get approved, Qnexa will probably need a risk evaluation and mitigation strategy (REMS), post-market studies, and warnings in its label, Carr says.
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