I try to stay put of these discussions as I've posted about Prolia already on other threads. But in case anyone who's not taking it yet, and is considering doing so, I fervently hope the person does a lot of due diligence.

The FDA's FAERS website of post-marketing* reported adverse effects currently lists over 140,000 (sic) adverse effects for denosumab. I didn't even include a search for the brand name, Prolia.

Considering that it's not been on the market in the U.S. for a full decade, that is a terrible record. Add that the FDA also added it to "recommend for investigation" for vasculitis in October, 2021.

Add that the adverse effects include 33,705 reported reactions under the 'musculoskeletal and connectivity tissue disorders.'

The Wall Street Journal reported that the pharmaceutical industry estimates that fewer than 15% of adverse effects are even reported to the public-access FAERS website and one can reasonably calculate that the real number of adverse effects is easily over a million.

In the interests of full disclosure, a 'reported' adverse effect is not conclusive unless verified by thorough investigation. But when there are thousands of similar reports, suspect a trend.

I'm not taking the drug and, by that fact, some think that I shouldn't post anything about it. But I do have osteopenia and as far as I'm concerned, we all have skin in the game and can share facts about a drug that can be prescribed to any of us. My concern is sharing information so we can make thoughtful decisions about our own care.

If the logic behind taking Prolia is that it's injected or infused a few times a year and therefore convenient, there are other alternatives with a longer history of safety and efficacy. If the idea is to avoid bisphosponate risks, the same risks apply to Prolia as it also is a bisphosphonate analog.

In my opinion, separate from the pure facts above, it's a terrible drug and, as the number of class action lawsuits against Amgen because of accumulated and new side effects previously not reported. I wouldn't be surprised to see it taken off the market in the U.S.

*Post-marketing means after a drug has been approved by the FDA. What makes this important is that the FDA's scrutiny of a new drug is primarily involved in the pre- and approval phase and falls off to barely monitoring the drug post-approval. We frequently don't hear of the post-approval incidents until lawsuits start popping up. Caveat emptor.

Note: I tried to post the website link to the FAERS data on denosumab but it's an app and not showing a URL. If anyone wants to see it, go to the FAERS website, accept the terms, wait for link to Public Dashboard and follow the instructions. It's not very user-friendly. I've learned to document sources in anticipation of someone asking where I found data.

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