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ISMP: Anti-TNF agents top list of drugs with serious adverse events


Humira (adalimumab) and Enbrel (etanercept) accounted for the largest number of injury reports received by the FDA last year, according to a new edition of the Institute for Safe Medication Practices’ (ISMP) QuarterWatch.

Humira (adalimumab) and Enbrel (etanercept) accounted for the largest number of injury reports received by the FDA last year, according to a new edition of the Institute for Safe Medication Practices’ (ISMP) QuarterWatch.

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Overall, there were 833,076 adverse drug events reported to the FDA in 2014, including 293,810 fatal, disabling and serious injury cases.

Top adverse events included:

Anti-TNF products

Humira and Enbrel, the two most widely-prescribed anti-tumor necrosis factor (TNF)-blocking drugs, were at the top of the list “mostly because of their potent effects on the immune system that increase the risk of opportunistic infections, reactivation of the hepatitis virus and cancer,” ISMP wrote.

There were almost 47,000 new injury reports associated with Humira and nearly 39,000 with Enbrel. Nearly a quarter of the Humira cases and one-third of the Enbrel cases indicated an infection, and more than 10 percent of the Humira and Enbrel cases indicated cancer, including 197 and 90 reported cancer deaths, respectively.

“A third large group of serious adverse events involved hypersensitivity. More than 10,000 injection-site reactions, mostly non-serious, were also reported for each drug,” ISMP wrote.


Newer anticoagulants

Pradaxa (dabigatran) had the highest overall total of serious adverse events reported among the three new anticoagulants, the largest total of reported severe hemorrhages, and the most patient deaths in 2014. “The mortality rate for dabigatran events, at 20.9 percent, was about double that of the other two new oral anticoagulant drugs (rivaroxaban [Xarelto] and apixaban [Eliquis]),” ISMP wrote. “Also, pharmacokinetic-pharmacodynamic data suggest that about 17 percent of patients taking dabigatran have subtherapeutic anticoagulation and therefore minimal protection against a stroke or heart attack. Nearly half receive more drug than needed, risking hemorrhage.”

“The FDA needs to take action to reduce the bleeding risks of [Pradaxa] by approving a lower dose (110 mg) for older patients and requiring drug-level blood tests to identify patients with subtherapeutic or excessive blood levels,” according to ISMP.

“Better guidance is needed regarding concomitant use of anti-platelet agents other than a simple warning that increased risk was observed. It is time to move towards individualizing the dose for all long-term anticoagulant therapy and drug-level blood monitoring when indicated,” ISMP wrote. 

Statin use in diabetes

Lipitor (atorvastatin) accounted for more than 4,700 reported legal cases in 2014, more than any other therapeutic drug. “Some event reports indicated known complications of diabetes, such as damage to the kidneys, vision, and nerves. However, these cases are allegations that have yet to be proven,” ISMP wrote.

Also, new research on diabetes risk and cholesterol-lowering drugs should be taken into account. “Women have a lower risk of cardiovascular disease than men, and if proven to have a two to three times higher risk of developing diabetes, guidelines for treating women with cholesterol-lowering drugs need to be reassessed,” ISMP wrote.

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