Nearly all children who admitted to a hospital intensive care unit (ICU) receive off-label medication. “Off label” is a term used to describe drugs that aren’t approved by the U.S. Food and Drug Administration (FDA) for treatment of a particular condition. While it’s legal for doctors to administer off-label uses of drugs, it comes with heightened risk since the FDA hasn’t declared the medication safe for the particular purpose.
Off-label use of drugs isn’t necessarily bad, as many medications have proven useful for treating conditions before the FDA approves them. Yet, like all pediatric medication errors, the risk involved with off-label prescriptions can be fatal. Wyeth Pharmaceutical’s drug, Prempro, provides a classic example of why off-label uses of medication can prove dangerous.
Prempro was a drug designed to treat symptoms of menopause and prevent osteoporosis, but several years ago Wyeth began advertising it to also prevent heart disease and mental deterioration. Thousands of physicians then prescribed the drug for those off-label purposes.
Studies have shown that Wyeth’s prior assertions weren’t only wrong: they were the opposite of the truth. Today, Prempro’s label specifically cautions that the medication may increase one’s chances of heart attacks, strokes and dementia. More than 10,000 Prempro lawsuits have been filed against Wyeth.
The Prempro story underscores why ICU physicians need to exercise more caution when prescribing off-label drugs to children. An unproven use of a drug is not only less likely to be effective, but it may cause life-changing side effects that impact the rest of a child’s life.
McKeen & Associates, PC, is a Michigan-based law firm that handles medical malpractice cases across the nation. Visit our case results page to review some of the cases we’ve won for our clients.
Source: medwire-news.md, “Almost All Children On Intensive Care Units Given ‘Off-Label’ Drugs,” Helen Albert, Oct. 23, 2012