Consumer watchdog petitions FDA for black box warning on Amgen's Prolia

The FDA has warned patients using Amgen’s osteoporosis drug Prolia that stopping treatment could lead to an increased risk of spinal fractures. Now, a consumer watchdog said the warnings haven’t gone far enough.

In a petition (PDF) filed Tuesday, Public Citizen called on the FDA to upgrade Prolia’s fracture risk to a boxed warning, the agency's most serious, instead of the current warning that's "buried deep in the label," the group said. The petition also urged FDA officials to require Amgen to notify doctors and update patient brochures to highlight Prolia’s risks.

"There is a growing body of evidence showing that cessation of Prolia is associated with an increased risk of multiple vertebral fractures," the petition stated. That risk could be "mitigated with a prominent boxed warning" and an updated risk-management program, the petition said. Those two steps would flag doctors and patients about the risk of stopping treatment, it said.

An Amgen spokeswoman said Wednesday the company believes Prolia’s benefit to patients outweighs its risks, while acknowledging clinical data showing former patients face an increased chance of fractures.

"We continuously monitor the safety of our products and communicate new safety information in a timely manner to the medical community in collaboration with the regulatory authorities," spokeswoman Jessica Akopyan told FiercePharma in an email. "Amgen has worked closely and has been fully transparent with regulatory authorities on the risk of MVF."

In its request, Public Citizen acknowledged that the FDA had noted the fracture risks and acted on that knowledge, but argued the agency hasn't gone far enough to update doctor and patient information to fully outline the risks.  

Approved by the FDA in 2010, Prolia raked in $2.29 billion worldwide in 2018, a 16% increase from the previous year.

Public Citizen frequently lobbies the FDA for greater oversight of drugs and medical devices, but those pleas have yielded mixed results. On Tuesday, the group applauded the FDA for calling a moratorium on pelvic repair surgical mesh devices, but said the agency had waited too long to act on the group’s 2011 petition to pull the products.

And last year, it called on the agency to take Takeda's gout drug Uloric off the market, citing new data that flagged an increased risk of heart problems and death. The FDA had announced a safety review in November 2017, and earlier this year it slapped a black box warning on the drug's label and pulled its approval in previously untreated patients.

The organization also pushed the FDA to red-flag risks of uncontrollable urges that have turned up in data on certain Parkinson's drugs. That request stemmed from a 2014 JAMA Internal Medicine study linking dopamine agonists with compulsive gambling, shopping and sexual behavior.

In 2012, Public Citizen filed a petition requesting Victoza be pulled from the market, suggesting the risks of thyroid cancer, pancreatitis and kidney failure far exceeded any benefits from a drug it said is not needed given that there are lots of alternative treatments for Type 2 diabetes. That petition temporarily sent Novo Nordisk’s stock into a tailspin, but the FDA says the evidence doesn't warrant that sort of action on Victoza or any of Public Citizen’s other petitions against Type 2 diabetes drugs.

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