By: Mahdieh Danesh Yazdi
As previously reported, there is currently great concern in the medical community because of the growing number of drug shortages. Many of these are drugs that are critical to patient care, such as chemotherapy agents and antibiotics. Last October, President Obama issued an executive order in an attempt to curb the ever-increasing number of drugs that are in dwindling supply. Part of the executive order addressed the FDA, which asked the agency to intervene (whenever possible) to avert a shortage. In compliance with the executive order, the FDA recently announced a successful attempt to stop the shortage of two major chemotherapy agents: methotrexate and doxorubicin.
Methotrexate is an antimetabolite drug often used in the treatment of cancers and certain autoimmune disorders. It works by inhibiting purine synthesis by interfering in the folate pathway. Methotrexate can treat various cancers including but not limited to acute lymphocytic leukemia (ALL), breast cancer, head and neck cancer, psoriasis, and rheumatoid arthritis. Doxorubicin is an anthracycline antibiotic that works by intercalating the DNA and preventing replication. It can treat AIDS-related Kaposi sarcoma, multiple myeloma, leukemia, and Hodgkin’s lymphoma.
Both of these drugs are critical for cancer treatment, but have been in short supply for some time. For methotrexate, the shortage was due to the shutdown of one manufacturer (out of four that supply it) amid concerns over its manufacturing quality. To alleviate the shortage, the FDA came to an agreement with the other three manufacturers to increase their drug production. The FDA also approved APP Pharmaceuticals’ application to produce a preservative-free version of the drug, which should be widely available by March. There are also reports of agreements with foreign manufacturers to compensate for the shortage of the drug. It was especially critical that the supply of methotrexate did not diminish further, as it is part of the treatment of choice for ALL (a leukemia commonly found in children). Not using it would compromise the care received by pediatric patients and jeopardize their chances of remission.
On the other hand, doxorubicin has been in short supply for several years. The FDA is allowing the importation of another formulation of doxorubicin, LipoDox, produced by Sun Pharma Global FZE. The FDA is confident about the quality of the manufacturing firm; it oversees production of other drugs by the same company (Ault).
With these steps, thousands of people who rely on methotrexate and/or doxorubicin as their fundamental treatment may now receive them in a timely manner. It is important to note that, despite these efforts, drug shortages continue to be a crippling problem within the medical world. To prevent future incidents and alleviate current shortages, it is imperative for us to address the problem at a fundamental level.
For a list of all current drug shortages, please visit:
– OR –
- Ault, Alicia. “FDA Acts to Curb Doxorubicin, Methotrexate Shortages.” 21 February 2012. Internal Medicine News. 25 February 2012 <http://www.internalmedicinenews.com/views/observation-unit/blog/fda-acts-to-curb-doxorubicin-methotrexate-shortages/766f825674.html>.
- Lexi-Comp OnlineTM , Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; February 25, 2012.
- Nelson, Roxanne. “Stopgaps Avert Methotrexate and Doxil Shortages–For Now.” 21 February 2012. Medscape. 25 February 2012 <http://www.medscape.com/viewarticle/758954>.