The U.S. Food and Drug Administration is expected to announce its decision on Friday afternoon, where the regulator is expected to decide whether or not to place a warning label on the opioid painkiller extended-release drug Ibrance. Pfizer’s drug, which is approved to treat patients with metastatic breast cancer, contains an anesthetic called beclomethasone dipropionate, which has been linked to sudden, unexpected death in rare cases, most common among patients who take the drug when it is used off-label for other conditions.
From here, the FDA staff will submit their conclusions and recommendations to the FDA’s advisory panel, where it is expected that a majority of the panel will vote to place a warning label on the drug, known as BID 3100. While the FDA also reviews safety claims for drugs, including warnings when there is too little medical evidence to support a product’s benefits, the agency’s advisers are required to decide on the matter based on the merit of the evidence.
Both the initial application and the overall review that Pfizer submitted in 2015 claimed that Ibrance did not cause any deaths, though, as we have previously reported, only three of the 26 adverse events reported in the clinical trials that included the anesthetic was considered serious. One of the deaths happened after the beclomethasone dipropionate had been used for only a couple of days, the FDA says, and the other death was prompted by a prescription for BID 3100 for a “noncancer-related cause.”
In the original 2015 application to the FDA, the company did not make any mention of safety concerns involving beclomethasone dipropionate, however, the official risk evaluation and mitigation strategy, or REMS, imposed by the FDA requires specific warnings for drugs involving a specific list of “involuntary death, birth defects, or serious neurological injury.”
That list was reportedly expanded in April to include a list of 24 conditions that beclomethasone dipropionate was approved to treat.
For more background on the beclomethasone dipropionate/pfizer controversy, see here.
Read the full story at Huffington Post.
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