Following the label, the label, the label

Just because a medicine is over-the-counter does not mean it is safe from overdosing! In fact, it is important to read the label for the active ingredient(s), strength of the ingredient(s), age recommendations, directions for use, and inactive ingredients (especially if you have known allergies to make sure cross-allergies do not occur). Other important information include warnings for use when your child has underlying conditions, like asthma (may result in an asthma attack), or having an increased risk of a heart attack or stroke when overusing (more or longer than directed) medications, like ibuprofen (brand names are Motrin and Advil). This addition to the label have been recently approved by the FDA for pediatric ibuprofen suspensions. Knowledge is helpful for safe medication use. We will be seeing more approvals for revisions to labels in upcoming months.

Speaking of ibuprofen, it is exciting that the FDA also recently approved an injectable formulation of the pain and fever reliever. The brand name is Caldolor. Although its use will be limited to hospital use only, it will be an important addition for pain treatment algorithms, especially for children with acute painful crises, such as those with sickle cell disease, and can't tolerate medication by mouth and need the combination of an opioid and a nonsteroidal antiinflammatory drug (ibuprofen). For postpartum pain, I preferred moderate doses of ibuprofen over opioids; the former was effective to control my pain after vaginal delivery and, surprisingly, after the c-section years later.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn."

Although pain is subjective, no one, not even a young child, should suffer from it.