The share of Pfizer’s cytarabine is dominating the Chinese market or even in the global market. The cytarabine referred to here is Pfizer’s product Cytosar™ which is the trade name, and its generic name is Cytarabine for Injection. It is mainly indicated for remission induction and maintenance therapy in acute non-lymphocytic leukemia of adults and children and also has therapeutic effects in other types of leukemia. According to a notice on the internet at the beginning of this year, Pfizer would conduct equipment overhaul for the production line of cytarabine, and cytarabine would be suspended production for a period of time due to the long overhaul and maintenance time. As a result, the shortage of cytarabine has been widely reported recently in China.
Similar phenomena already happened in the U.S., and it is history repeating itself
Shortages of some pharmaceutical products are a global phenomenon. Pharmaceutical product shortages of different degrees and involving different varieties happen at different times worldwide, especially generic drugs and cheap drugs that have already become off-patent. The shortage of chemotherapy drugs is normally more crucial as most of them have no equivalent substitutes. For example, the U.S. had a similar shortage of cytarabine early in 2011, and there had been no drug stock in the whole U.S., during which, doctors at a hospital in the U.S. purchased a batch of imported drugs from Switzerland, and it took at least 21 days for the drugs to go through all procedures to enter the hospital for use (AJHP, 2012, 69(16): 1416-1421.). And according to a report of FDA in 2017, there was another shortage of cytarabine in the U.S., as shown below:
Participation of cytarabine in treatment is a matter of life and death
As an old anti-cancer drug, cytarabine was first applied in 1969, and it is also a general-purpose cancer drug, for example, cytarabine used in combination with anthracycline antibiotics can treat acute myelocytic leukemia and lymphoma, etc. and it is also commonly seen in alternative regimens for treating other cancers; in particular, in some specific chemotherapy regimens, the combination of chemotherapy drugs and cytarabine can achieve a 40%-50% cure rate of leukemia, however, this figure is 0% if cytarabine is absent. For those patients, access to cytarabine is a matter of life and death.
Drugs in the "gray market" are from unknown sources with big risks
Leukemia tops in the morbidity and mortality of malignant tumors among children in China. Cytarabine is mainly used in leukemia chemotherapy and transplantation preconditioning; in particular, large doses of cytarabine are generally needed in consolidation chemotherapies following the remission of acute myelogenous leukemia and transplantation preconditioning regimens for different types of leukemia. Unlike the use of other common drugs that is measured by milligram, the use of cytarabine is measured by gram, with the difference being several orders of magnitude. The news of production suspension of cytarabine has led to the panic of tumor patients and their family members in China, who have tried to purchase from the online "grey market" for substitution in the short term.
Such drug purchase behavior is highly risky. Firstly, sources of drugs cannot be guaranteed, and there is the possibility that they will buy counterfeit drugs that are completely ineffective, such as drugs from India. India has various patent drugs and numerous generic drugs, however, it is also one of the largest producers of counterfeit drugs. Secondly, the application of cytarabine may cause various adverse reactions. For example, it can lead to certain degrees of myelosuppression; cytarabine can result in drug fever (high fever), which may be low-grade fever or high fever with temperature over 40℃ (with an increase of white blood cells, neutrophils, and c-reactive protein, etc.), requires close observation and dose adjustment after the use, and is very easily confused with bacterial infection. Finally, there is price fraud in the grey market, where those illegal drugs may be sold far higher than their original prices, resulting ...
(All Rights Reserved)