Much ink has been spilled about the dangerous of compounding pharmacies and the patients injured by their drugs. Adding to this ink, a recent report was published that exposed how inadequate drug safety truly is in the United States; at the same time, at least 17 Texas patients have suffered illnesses from contaminated drugs from compounding pharmacies. Dangerous drug lawyers at Pintas & Mullins Law Firm go into deeper detail on both these new reports.
The compounding pharmacy responsible for the illnesses is Specialty Compounding, located in Cedar Park, Texas. The pharmacy recently issued a national recall of its calcium gluconate after many patients at two Corpus Christi hospitals fell ill. Calcium Gluconate is used to treat many different ailments, including heart conditions, calcium deficiency, black widow spider bites, and rickets.
Unfortunately, the calcium solutions made by Specialty Compounding and given to the patients in Corpus Christi were contaminated with bacteria called Rhodococcus equi. This bacterium can be extremely difficult to treat and eradicate and can cause pneumonia, hemoptysis, dyspnea, and fever and cough.
The FDA analyzed the calcium solutions responsible for the outbreak and found many other strains of bacteria as well. The agency then visited Specialty Compounding’s facilities, documenting unsanitary conditions and a myriad of violations of manufacturing practices. According to investigative reports, the FDA determined that Specialty was manufacturing unapproved and misbranded drugs and distributing drugs without prescriptions.
The previously-mentioned study was published by the Institute for Safe Medical Practices, focusing on how the FDA collects adverse drug events. The FDA Adverse Events Reporting System (FAERS) is voluntary, and most of its information comes directly from pharmaceutical companies. The problems with this system are obvious, and result in low-quality, incomplete, and often useless information.
Making matters worse, the FAERS system is critically important to public health and safety. First, most safety warnings released by the FDA are based on these FAERS reports because it is the most reliable way the agency can discover new drug risks and side effects. Second, no other system has the ability to detect life-threatening side effects or the capacity to pinpoint unexpected injuries. It is the main tool in assessing medical product safety.
Why should we care about the FAERS system and its flaws? Because, as Brian
in his MedPage article, it is we who pay the price for the hospitalizations, illnesses and deaths
caused by drugs and medical devices. It is our loved ones who suffer from
drug side effects, and our tax dollars that pay for the FAERS system itself.
The responsibility for reporting drug side effects should not fall on the shoulders of Big Pharma, which has everything to gain by falsifying the data. Nothing will change unless we start a dialogue and request systemic change.
Our team of dangerous drug lawyers encourages anyone who was seriously injured by a medication to contact our firm as soon as possible. We provide free case reviews to anyone with questions or concerns about a recalled drug or injuries sustained from drugs or medical devices. We accept clients nationwide, and are always willing to come to you to help guide you through the legal process.