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Posted by on Feb 16, 2012 in Business, Health | 12 comments

Methotrexate: Yet Another Shortage Of A Lifesaving Drug Because Of Manufacturer Neglect

For me, the drug methotrexate is the difference between discomfort and comfort. For children with certain forms of leukemia, it is the difference between life and death. And yet another cautionary tale about regulation of the profit-greedy American drug industry.

Methotrexate has been around for six decades and has long proved to be effective against acute lymphoblastic leukemia (ALL), which strikes thousand children each year, as well as osteogenic sarcoma. In injectable preservative-free form, it is nothing less than a lifelong cure for many sufferers. I take a tablet form of methotrexate to manage my rheumatoid arthritis. It is inexpensive compared to the rheumatoid arthritis drugs that are television commercial staples and I am thankful that it works for me. For other suffers, it does not.

There is a shortage of preservation-free injectable methotrexate because yet another drugmaker has been cited for running filthy operations.

Ben Venue Laboratories of Bedford, Ohio, was shut down in November after flunking yet another FDA inspection.

“If you want to read something to give you nightmares, you can look at the FDA 483 inspection form,” says Erin Fox, an expert on drug shortages at the University of Utah. “You can read about mold on the walls and rust from machinery falling into the vials. It really provides a very grim picture of a crumbling factory.”

The same lab is responsible for another recent and far-reaching drug shortage involving Doxil, a drug relied on by thousands of patients with ovarian and breast cancer. Ben Venue was the sole worldwide supplier of Doxil, which is now unobtainable.

Fox says most people don’t realize how decrepit many U.S. drug plants are, especially those that make generic drugs.

Ben Venue Laboratories says it has invested more than $250 million over the past three years to upgrade its facilities, “and continues to invest millions more in order to restore production as quickly as possible.”

The FDA says the methotrexate crisis may be narrowly averted because the agency has persuaded to ramp up production of preservation-free injectable methotrexate.

Brenda Carr’s 4-year-old daughter, Rowen, is a leukemia patient at Children’s Hospital and Clinics of Minnesota.

“What I just couldn’t believe was that there was nothing really to prevent this from happening,” Carr says. “It gets really frustrating. I try to stay logical about it, but, unfortunately, I’m a mom.”

Doctors inject methotrexate directly into the spines of patients with ALL. For those with the bone cancer, they must use very high doses of the drug. In such cases, the methotrexate must be free of an alcohol-based preservative that is highly toxic at high doses. Otherwise, it could result in paralysis.

Carr says she has her fingers crossed. But she’s skeptical.

“This isn’t the first time we’ve been on the brink of drug shortages, especially in cancer treatments,” Carr says. “I don’t want another mom to have to be thinking about whether or not their child is going to get the medication they need.”

Experts say there certainly will be other parents who will have to worry about other shortages, because the root causes will not be easily resolved.

happening,” Carr says. “It gets really frustrating. I try to stay logical about it, but, unfortunately, I’m a mom.”

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