Professional Compounding Centers of America (PCCA) has been named a defendant in several civil lawsuits brought by individuals diagnosed with retinal damage, partial blindness, and blindness after using a compounded form of TriMoxi, an eye drop used after certain types of eye surgery that is supposed to speed healing.
Compounding and Imprimis Pharmaceuticals
In a normal compounding pharmacy, patients will drop off their prescription drugs and the pharmacy will make personalized dosages or forms of the medication in question using a specific formula. But in the case of the knock-off version of TriMoxi, the formula of the drug had never been tested and was found flawed.
The company that actually makes TriMoxi, Imprimis Pharmaceuticals, calls for a less than 3 percent portion of a chemical compound called poloxamer. Conversely, the compounded version of TriMoxi that was compounded at Guardian Pharmacy Services contained up to 12 percent of the poloxamer.
The compound’s toxicity then caused retinal damage and blindness in those administered the injectable eye drops.
Who’s Really to Blame?
While two eye clinics have had lawsuits brought against them for purchasing bulk amounts of the mock TriMoxi injections, and Guardian Pharmacy Services has also been named in a civil suit for mixing the drug, the true fault falls on the PCCA for providing improper formulas to the compounding pharmacy, which were then sold to physicians who could administer the drug.
Although the case has yet to be resolved, this is a classic example of why compounded drugs and their respective pharmacies should be regulated by the FDA and held accountable for the adverse effects brought by their defective drugs.
Why Compounding Pharmacies Should Be Regulated
People go to compounding pharmacies for customized drugs that are not available through corporations that produce pharmaceuticals. Due to the fact that drugs produced by compounding pharmacies are not allowed to recreate pharmaceutical company’s drugs, the compounded drugs are not regulated by the FDA.
This brings both the effectiveness and safety of the drug itself into question, as it hasn’t been tested. Had the compounded version of TriMoxi that Guardian produced been tested for safety prior to its widespread use, patients who received the injectable eye drops may have been spared their vision.
Unfortunately, only pharmacies who volunteer to be regulated by the FDA will be, so if you are someone looking for a compounded drug, you may want to visit one of the 70 compounding pharmacies in the US that have signed up for federal oversight.