FDA Makes a Cancer Treatment More Available


The U. S. Meals and Medication Administration announced Tuesday what it called a series of steps to ensure the continued option of vital cancer medicines that have experienced dangerously short supply. Among the drugs, methotrexate, is used in combination with other drugs to combat — and in many cases cure — severe lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.And another medication, Lipodox, will be temporarily imported from a pharmaceutical company in India to help ease a shortage of the chemotherapy medication Doxil (doxorubicin), which is used to treat ovarian malignancy, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is comparable in chemical makeup to Doxil; there are no generic versions of Doxil.”Through the collaborative function of [the] FDA, sector and other stakeholders, sufferers and families looking forward to the products or anxious about their availability should today be capable of geting the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg stated in a news release. The FDA also stated it had been issuing recommendations to the drug industry that spell out detailed requirements for “both mandatory and voluntary notifications” to the agency of potential issues that could lead to a drug shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with severe lymphoblastic leukemia. In high doses, the generic medication has been successful in curing individuals and beneficial in preventing recurrence. Without the medication, a patient’s opportunity for a cure is reduced as the threat of recurrence rises, oncologists stated. Some cancer doctors had warned last week that products of methotrexate could possibly be exhausted within a fortnight. To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug manufacturers to help maintain products to meet all patient needs. Preservative-free methotrexate is necessary for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of kids with ALL, the company said. The FDA stated the steps taken with methotrexate included approving a preservative-free edition of the generic medication produced by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has sped up additional supplies, generating 31,000 new vials of the medication — enough for several month’s supply. Those extra vials are being delivered Tuesday to a huge selection of U. S. hospitals and treatment centers, the FDA said. The FDA also noted that it continues to work with other manufacturers of methotrexate which have also stepped up production. Those manufacturers consist of Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, one of the speakers was Sara Stuckey, mother of 6-year-outdated Nate Stuckey, who has been on methotrexate since he was diagnosed with ALL in 2009 2009. “It is hard enough to listen to your child has cancer, but to hear that the treatment that’s successfully working is instantly unavailable is devastating,” she stated. “My husband and I pray the recommended drugs to fight his cancer will be available when it’s time for Nate’s following treatment. And we hope that later on no more families need to go through the stress of wondering whether proved, lifesaving treatments will end up being out of reach when they need it the many.”Speaking in the news conference, Hamburg stated: “There are too many families just like the Stuckeys who worry they don’t have the medicine they need for their next treatment and are understandably anxious about switching to a medicine that may have significantly more side effects or may be less effective. Clearly this is not suitable.” “We are making improvement,” Hamburg added. “There have been 195 drug shortages prevented in 2011 and 114 drug shortages avoided since October 2011 whenever we made the call for early notification” of potential shortages. For the ovarian cancer medication Lipodox, the FDA said it’ll allow the short-term importation of the medication made by Sun Pharma Global FZE. The company said in its information release that “short-term importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an accepted drug that’s critical to patients and the shortage can’t be resolved in a timely fashion with FDA-approved drugs.” The shortages of methotrexate and Doxil are just the latest in some drug shortages which have existed for quite some time. In 2011, prescription medication shortages in the usa hit an all-period high. Last fall, some 200 drug shortages have been reported, in comparison to 178 in all of 2010, the FDA reported. Most of the scarce drugs are injectables, such as cytarabine and cisplatin, used to take care of serious conditions such as cancer. Some are only provided in hospitals and are “absolutely vital,” Valerie Jensen, associate director of the FDA’s drug shortage program, said throughout a news meeting last September. More than half (54 percent) of shortages this year 2010 were because of quality problems, such as medication impurities. Some were due to delays or manufacturing capability complications, while 11 percent were due to discontinuation of a drug and 5 percent resulted from raw materials shortages, Jensen stated. Jensen also said the shortages have a tendency to occur in medicines that aren’t “economically attractive.” This could mean that only 1 company produces the medication, making it harder to discover alternatives if the supply dries up. A lot of the complications are tied to generic drugs, health specialists explained, because few manufacturers make them and income aren’t as high for brand-name medicines still under patent security. On Oct. 31, 2011, President Barack Obama signed an executive order designed to help relieve the medication shortages. The order directed the FDA to “take action” to avoid and decrease worsening prescription drug shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Culture of Hematology (ASH), stated in a declaration: “ASH is motivated by the actions FDA is taking to ease drug shortages that have significantly affected so many patients with hematololgic malignancies under our associates’ care. The steps announced today are consistent with the Society’s recommendations to FDA, Congress and the NATIONAL GOVERNMENT to increase the agency’s authority to avoid drug shortages by requiring producers to supply early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the precise actions announced today,” Keating added, “we also understand these measures represent just some of a remedy to a much larger problem. Furthermore to these steps, extra measures — such as for example developing a national medication registry and providing financial incentives to manufacturers to make a steady way to obtain generics — must be implemented to completely prevent shortages. Until a comprehensive solution is in place, treatment will become delayed and treatment will become rationed for critically ill individuals.”

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