ETHEX Drug Recall Affects Thousands of Patients

Baltimore, MDIf you heard about the recent ETHEX recall and breathed a sigh of relief because you thought it did not affect you, you may want to think again. The recall of ETHEX generic drugs has had wide-ranging implications for thousands of patients. Some patients experienced an ETHEX overdose while others are suffering because their medications are now in severe shortage. Meanwhile, questions are still being raised about the safety of ETHEX drugs.

In February 2009, ETHEX Corp recalled 60 medications after its manufacturing practices came under scrutiny by the US Food and Drug Administration (FDA). Since the recall was announced, KV Pharmaceutical, parent company to ETHEX, has reached a settlement—known as a consent decree—with federal prosecutors, preventing the company from producing drugs until it complies with FDA regulations.

Among the complaints against KV are that the company did not comply with FDA regulations and that it made new drugs that were not approved for distribution. According to a complaint filed by prosecutors, these allegations are similar to violations reported in the past 8 years against KV. The complaint also noted that during FDA inspections conducted between December 15 and February 2, 2009, 35 separate deviations from manufacturing regulations were uncovered.

An initial recall of ETHEX drugs was announced because some of the drugs were oversized and may have contained too much morphine and other active ingredients. However, the latest recall expanded the list of drugs involved and included vitamin and iron supplements.

Before the company can resume manufacturing of its drugs it must have an independent consultant review its facilities to ensure they comply with FDA requirements. KV could also be forced to pay $15,000 per day for each day it does not comply with the consent decree. A further $15,000 for each violation could also be assessed against the company.

So far, KV has not announced when it will be able to comply with FDA regulations. KV also faces private lawsuits from consumers, alleging they were harmed by the use of KV drugs.

The recall has left hospitals and pharmacies scrambling to line up new suppliers, but the demand for the medications has been hard to fill. Some patients have been unable to fill oxycodone prescriptions, while pharmacies have depleted their stocks. Shortages of Percocet and metroprolol ER, the generic version of Toprol XL, have also been reported. This has left patients to choose between not having their medication at all or having the more expensive brand-name version.

The recall of so many generic drugs has left some patients wondering if generic versions are as good as the name brand versions. After all, they are sold at a greatly reduced price. How can they be as good if they are made so cheaply?

One answer could be that the way the generic drugs are manufactured decreases their costs. After all, the ETHEX recall was announced because of its manufacturing practices. "The products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (an FDA requirement)," according to a statement from ETHEX.

Although the recall of ETHEX drugs lessens the potential for harm being done to patients, there are some who say they have already suffered irreparable injury due to the medications. Some people say that their loved ones died or suffered serious harm because they were exposed to too much morphine or other active ingredients. They are left wondering how it is possible that KV could have been cited for so many violations in such a long period but still been allowed to produce medications.

Apparently, once again, a company has put profit above patient safety and, once again, patients have paid the price.