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FDA Has Delayed Reaction in Pulling Prescription Painkillers

Home | Articles | FDA Has Delayed Reaction in Pulling Prescription Painkillers

While many times pharmaceutical companies are to blame for manufacturing dangerous drugs, there are times when federal agencies, like the FDA, may contribute to the negative impact unsafe drugs have on the public. One case in point concerns Darvon and Darvocet, two prescription painkillers recently removed from the market by the FDA after many years of apprehension from the medical community. This delayed withdrawal of risky drugs from the market has medical professionals, patients and the general public questioning the FDA’s regulatory methods.

Deadly Painkillers and Delayed Reactions

Over 30 years ago, a consumer group first raised concerns about propoxyphene, which is the drug behind the brand-names Darvon and Darvocet. The group, Public Citizen, attempted to get the drug pulled from the market by petitioning federal lawmakers. It and other medical professionals warned the drug is highly addictive and can be toxic to the body, even at low doses, because it causes a metabolite to accumulate. This, in turn, may have caused cardiac problems, and also deaths, for patients who regularly took these drugs.

Although propoxyphene has been on the market for over 50 years, it has been contested for most of its existence. Forms of this drug were banned in England in 2005 and all of the European Union in 2009. The FDA removed Darvon, Darvocet and related generics from the market in late 2010, citing cardiac issues and death as the main reasons for the ban. However, the FDA’s delayed reaction may be too late for thousands of American patients already injured or deceased due to use of the dangerous drug, according to Public Citizen.

Actions Justified?

According to the FDA, the agency took the time it needed to study the safety and uses of propoxyphene and related drugs Darvon and Darvocet. The FDA’s findings were essentially that even low levels of the drug created cardiac issues, like abnormal heart beats, and the possibility of sudden death from heart attacks. While their reasoning that further study was needed may be justifiable, it is difficult to understand given that their findings were the same as were claimed many years previously by the medical community and Public Citizen.

Further Review

Is it all’s well that ends well in this scenario? For some, the FDA’s delayed reaction was a sign that the agency lags behind Europe in patient safety, even though it eventually took the right action. For others, the FDA acted poorly for too long to protect patients from a dangerous drug, like with Vioxx, which caused almost 140,000 heart attacks during the five years the FDA allowed it on the market. If you or your loved one was prescribed propoxyphene or another dangerous drug, contact a Rhode Island medical malpractice attorney about potential litigation and options for compensation.