Drugs

62% of FDA-approved Biologics Have Boxed Warnings

A Milwaukee Journal Sentinel investigative report says that of 21 biologic drugs approved by FDA, 62% (13 drugs) have received an agency Boxed Warning. In the majority of those cases, the Boxed Warning was added when new problems were identified after the drug went on the market. The lengthy report reviews the cases of several individuals taking biologics for conditions caused by an overactive immune system. The patients report that the drugs can lead to substantial improvement and even remission, but often at the expense of sometimes-deadly infections and other serious side effects.

The report cites a 2017 study of new drugs published in the Journal of the American Medical Association that found that of 222 drugs that entered the market between 2001 and 2010, only 27% later received a Boxed Warning.

“The individual risks from biologic drugs are rare,” the story says, “but they span a growing range of serious problems, including invasive fungal infections, tuberculosis, listeria and legionella, an often-fatal viral brain infection, cancer, heart failure, and liver failure. What’s more, in rare cases the drugs may leave some patients who are using them to treat autoimmune diseases susceptible to contracting other autoimmune diseases.”

An earlier Journal Sentinel analysis of FDA data found reports linking biologics to more than 500,000 serious side effects since 2004, including more than 34,000 deaths. The analysis focused on 19 drugs still on the market and was limited to biologics used to treat conditions of the skin, joint, and gastrointestinal system.

FDA told the newspaper it issues Boxed Warnings when a serious or life-threatening risk is detected but the drug’s overall benefit/risk profile remains favorable.

FDA spokesman Nathan Arnold said that “new safety issues can arise at any time regardless of how long a drug has been in use or its past record of safety.” He added that “much work still remains to monitor approved drugs over time. No drug is risk-free, and it is not uncommon for new information to be discovered after a drug is on the market and being used by larger numbers of patients.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome