Medicine is supposed to make patients better, but what happens when the medicine itself is making a patient sick? Kaiser Health News reviewed thousands of Food and Drug Administration documents in a recent study, including inspection records, warning letters, recalls and filed lawsuits, in an effort to find out how defective and dangerous drugs or drugs that are poorly manufactured or contaminated can end up in the hands of consumers. Such was the case for 1-year-old Anderson Moreno who received stool softener during a hospital stay that was ultimately found to be contaminated with the bacterium Burkholderia cepacian, or B. cepacia.
The stool softener in question is actually an over-the-counter remedy to soften the stool known as docusate sodium. It is prescribed routinely to nearly all patients who are hospitalized. The 1-year-old child in this case, hospitalized in Texas and awaiting a heart transplant, developed life-threatening complications due to the exposure of B. cepacia, which kept resurfacing in his body and ended up combining with a flu-type illness and causing a respiratory infection that put him on a ventilator.
When hospital staff noticed a rise in B. cepacian infections, a six-month investigation eventually traced the source back to a Davie, Florida, manufacturing plant that produces the stool softener. The tainted drug has since been recalled by the FDA.
The FDA is charged with the task of inspecting all factories, both here in the U.S. and abroad, that produce drugs bound for the U.S. market. Since 2013, pharmaceutical companies have recalled roughly 8,000 medicines that entered the U.S. drug supply and ultimately into medicine bottles and patient IVs, despite FDA inspections clearing them for market, according to Kaiser’s study. These contaminated drugs were found to contain things such as mold, tiny particles of glass, and various types of dangerous bacteria. In the same period of time, 65 facilities that make drugs also recalled nearly 300 products within a one-year period of the products passing the FDA’s inspection. At least 63 people in 12 states developed a serious infection from the contaminated stool softener that had passed FDA inspection prior to sale.
The Kaiser study also brought to light some shocking recalls. Among them were 12,000 boxes of off-label naproxen sodium that actually contained the drug ibuprofen; “super potent” doses of the drug Abilify; and 39,000 bottles of Atripla, an HIV-drug, that contained red silicone rubber particulates.
Industry consultants say that these inspections don’t always unearth problems with drugs because it is easy for inspectors to “miss things when they’re working with confusing regulatory terms and standards that are often decades out of date.” It is obvious that there needs to be an overhaul in the way that inspections are carried out. Until then, patients are at undue risk.
If you or someone you love has been affected by a dangerous drug, contact our San Francisco product liability attorney right away to discuss your case and determine the best legal options available to you.