Arthur Elk: Drug approval system often leaves unforeseen victims

Posted in Drug & Medical Devices on April 10, 2013

By Arthur Elk

Do you worry about taking prescription medications? Probably not. Most of us trust that before a drug goes to market it has undergone rigorous testing. However, sometimes, even with testing, a drug can make it to market with deadly results.

Less than a year after being approved, Omontys, a drug used to treat anemia in patients undergoing kidney dialysis, has been recalled. The recall occurred after the U.S. Food and Drug Administration received 19 reports of anaphylaxis, a severe allergic reaction, and reports that three of the patients had died.

The drug, officially known as peginesatide, was approved for use last spring by a near unanimous vote (one member abstained from voting).

Affymax and Takeda, the two companies selling peginesatide, said that about 0.2 percent of the 25,000 patients who had received the drug had suffered some type of hypersensitivity reaction, with about one-third of those considered serious and 10 percent of them resulting in death.

According to the FDA, the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration. There have been no problems reported with subsequent doses, which are given once a month. But the FDA and Affymax and Takeda recommended that Omontys use be discontinued, even by patients who had already been given more than one dose.

Some experts say the recall is a signal that the U.S. system for drug approval and safety monitoring works. But try telling that to the families of the patients who died after taking Omontys without being aware of the possibly deadly consequences. I doubt they would say the system worked. At least three people took this drug trying to improve their lives, and instead lost them.

This incident is a good reminder of the truth about our drug testing system. Testing and oversight are necessary to ensure that there will be no unforeseen complications. When complications arise, victimized patients need to seek competent, experienced legal counsel.

If you or a loved one has been injured by a recalled drug, we want to help. View a list of drugs we currently are investigating. Contact Elk & Elk today and find out how we can help you get the results you deserve. Call 1-800-ELK-OHIO or fill out our free, no-obligation online consultation form.