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FDA Makes a Series of Steps to Provide Availability of Vital Cancer Drugs

The U. S. Meals and Medication Administration announced Tuesday what it known as a number of steps to guarantee the continued availability of vital cancer medications that have experienced dangerously short supply. Among the drugs, methotrexate, is used in combination with other medicines to combat — and in many cases cure — severe lymphoblastic leukemia (ALL), the most common kind of cancer in children. It typically strikes kids aged 2 to 5.And another drug, Lipodox, will become temporarily imported from a pharmaceutical business in India to help ease a shortage of the chemotherapy drug Doxil (doxorubicin), which is utilized to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is similar in chemical make-up to Doxil; there are simply no generic versions of Doxil.”Through the collaborative function of [the] FDA, sector and other stakeholders, individuals and families looking forward to the products or anxious about their availability should right now be able to get the medication they need,” FDA Commissioner Dr. Margaret A. Hamburg said in a news release. The FDA also stated it was issuing guidelines to the drug industry that spell out detailed requirements for “both mandatory and voluntary notifications” to the company of potential issues that could result in a drug shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic medication has been successful in curing sufferers and beneficial in stopping recurrence. Without the medication, a patient’s opportunity for a remedy is reduced while the risk of recurrence rises, oncologists stated. Some malignancy doctors had warned the other day that products of methotrexate could be exhausted within a fortnight. To offset the shortage of methotrexate, the FDA said Tuesday that it spent some time working with several drug producers to help maintain materials to meet up all patient needs. Preservative-free methotrexate is necessary for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with ALL, the agency said. The FDA stated the steps used with methotrexate included approving a preservative-free edition of the generic medication produced by APP Pharmaceuticals, of Schaumburg, Ill. Those materials should become obtainable in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which currently manufactures methotrexate, has increased additional supplies, creating 31,000 new vials of the medication — enough for several month’s supply. Those additional vials are being delivered Tuesday to a huge selection of U. S. hospitals and centers, the FDA stated. The FDA also noted that it continues to work with other manufacturers of methotrexate which have also stepped up production. Those producers consist of Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday news conference Tuesday, among the audio speakers was Sara Stuckey, mother of 6-year-old Nate Stuckey, who has been on methotrexate since he was identified as having ALL in ’09 2009. “It is hard enough to listen to your son or daughter has cancer, but to hear that the treatment that’s successfully working is suddenly not available is devastating,” she stated. “My husband and I pray the recommended drugs to fight his cancer will be available if it is time for Nate’s following treatment. And we hope that later on no more families have to go through the stress of wondering whether tested, lifesaving treatments will end up being out of reach when they need it the the majority of.”Speaking at the news meeting, Hamburg stated: “There are way too many families just like the Stuckeys who get worried they don’t have the medication they need for their next treatment and so are understandably anxious about switching to a medicine that may have significantly more side results or may be less effective. Obviously this is not suitable.” “We are making progress,” Hamburg added. “There have been 195 medication shortages prevented in 2011 and 114 medication shortages prevented since October 2011 when we made the call for early notification” of potential shortages. As for the ovarian cancer medication Lipodox, the FDA said it will allow the short-term importation of the medication made by Sun Pharma Global FZE. The agency said in its news release that “temporary importation of unapproved international drugs is considered only in rare cases when there is a shortage of an accepted drug that is critical to sufferers and the shortage cannot be resolved in a timely fashion with FDA-approved medicines.” The shortages of methotrexate and Doxil are just the latest in a series of drug shortages that 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 had been reported, compared to 178 in all of 2010, the FDA reported. Many of the scarce medicines are injectables, such as cytarabine and cisplatin, used to treat serious circumstances such as cancer. Some are just provided in hospitals and so are “absolutely critical,” Valerie Jensen, associate director of the FDA’s medication shortage program, said throughout a news conference last September. More than half (54 percent) of shortages this year 2010 were due to quality problems, such as medication impurities. Some were caused by delays or manufacturing capability complications, while 11 percent were caused by discontinuation of a medication and 5 percent resulted from raw materials shortages, Jensen stated. Jensen also said the shortages tend to occur in drugs that aren’t “economically attractive.” This could mean that only 1 company produces the drug, making it harder to find alternatives if the supply dries up. A lot of the problems are linked with generic drugs, health specialists explained, because few producers make them and income aren’t as high for brand-name drugs still under patent safety. On Oct. 31, 2011, President Barack Obama signed an executive order designed to help relieve the drug shortages. The order directed the FDA to “do something” to prevent and decrease worsening prescription drug shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), stated in a statement: “ASH is encouraged by the guidelines FDA is taking to ease drug shortages that have considerably affected so many sufferers with hematololgic malignancies under our associates’ care. The actions announced today are constant with the Society’s recommendations to FDA, Congress and the Obama Administration to increase the agency’s authority to avoid drug shortages by requiring producers to provide early notification of impending shortages and importing medicines in critical supply.”
“While ASH applauds the specific actions announced today,” Keating added, “we also realize that these measures represent just some of a remedy to a much larger problem. Furthermore to these steps, additional measures — such as for example developing a national medication registry and providing economic incentives to producers to make a steady way to obtain generics — must be implemented to completely prevent shortages. Until a complete solution is in place, treatment will be delayed and treatment will end up being rationed for critically ill individuals.”


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