“Off Label” Drug Marketing: Are Your Family’s Medications a Safe Fit?

Patient Care, Updates

Have you ever wondered whether the prescription your doctor has given you is really intended for you? It’s a very good question. Drug companies market their products to physicians, sometimes for conditions not mentioned on the drug’s Food and Drug Administration (FDA)-approved label. Physicians may not always know when the drug’s abilities have been overstated, and prescribe you a drug not originally made for your condition.

This is called “off-label prescribing”. Widely used drugs like Miralax and Zofran have come under fire recently for being linked to health issues when not used in accordance with FDA-approved labeling. For this reason, it’s important to do your research on a drug is important before you begin a new medicine regimen.

What does “Off-Label” Mean?

The FDA must approve any drug that goes on the market. This includes naming what the drug is intended to do.

According to the FDA, off-label prescribing “mean[s] that the drug is:

  • Used for a different disease or medical condition.
  • Given in a different way (such as by a different route).
  • Given in a different dose.”

Drugs Like Zofran and Miralax Have Given Warning Signs

Many people can take a drug off label with no problem. But when problems pop up, patients should pay attention.

One example is the drug Zofran (ondansetron). Originally prescribed for cancer and post-surgical patients, it is also being used to treat morning sickness in pregnant women. Studies done in 2012 and 2013 showed increased risk for cleft palate and congenital heart defects in newborns whose mother took Zofran in their first trimester. The FDA also issued a warning about ondansetron causing potential heart defects in babies. Yet, the drug is still prescribed by many doctors for pregnancy-related nausea.

The laxative drug Miralax is also getting some heat, namely for its main ingredient polyethylene glycol, or PEG. Miralax’s label originally stated that it was not intended for children, but the label has since changed. Many physicians now prescribe PEG laxatives for children, even though these drugs have been connected to neuropsychiatric events such as tremors, tics and obsessive-compulsive behaviors. The FDA is funding research to better understand the long-term effects of the drug, and whether its absorption in the colon differs in children and adults.

Off-Label Safety is in Your Hands

What can you do to learn more about a drug before taking it? Searching for a drug online will tell you its intended use. You should also talk to your pharmacist about the drug. Find out if your prescription is approved to use with your condition, and if the dosage you are given is appropriate. If the medicine is for your child, ask if the medicine has been approved for non-adult use. Most importantly, ask about all known side effects caused by the drug.

The Cerebral Palsy Family network Facebook page is often filled with parents’ questions about different drugs. Why? Because parents know that medications can have different reactions for each child. It’s important to understand whether a new medication’s benefits outweigh its risks, especially when going “off label”.

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