FDA Began to Head Off Lack of 2 Cancer Drugs

The U. S. Meals and Medication Administration announced Tuesday what it called a number of steps to guarantee the continued availability of vital cancer medications that have been in dangerously short supply. One of the drugs, methotrexate, is utilized in mixture with other drugs to combat — and in many cases cure — severe lymphoblastic leukemia (ALL), the most typical type of cancer in children. It typically strikes children aged 2 to 5.And another medication, Lipodox, will end up being temporarily imported from a pharmaceutical firm in India to help ease a shortage of the chemotherapy medication Doxil (doxorubicin), which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is comparable in chemical make-up to Doxil; there are no generic variations of Doxil.”Through the collaborative work of [the] FDA, industry and other stakeholders, individuals and families looking forward to these products or anxious about their availability should at this point be capable of geting the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg said in a news launch. The FDA also stated it was 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 result in a drug shortage or supply disruption. Methotrexate is a cornerstone in the treating children with severe lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the medication, a patient’s opportunity for a cure is reduced as the risk of recurrence rises, oncologists said. Some cancer doctors had warned the other day that items of methotrexate could be exhausted within two weeks. To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug producers to help maintain items to meet all patient needs. Preservative-free methotrexate is necessary for the intrathecal (injection in to the fluid surrounding the brain and spinal cord) treatment of children with ALL, the agency said. The FDA stated the steps taken with methotrexate included approving a preservative-free version of the generic medication manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those products should become available in March and continue indefinitely, the company said. Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has increased additional supplies, generating 31,000 new vials of the drug — enough for several month’s supply. Those additional 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 producers of methotrexate which have also stepped up production. Those manufacturers include Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, one of the loudspeakers was Sara Stuckey, mother of 6-year-outdated Nate Stuckey, who provides been on methotrexate since he was diagnosed with ALL in 2009 2009. “It really is hard enough to listen to your child has cancer, but to listen to that the treatment that’s successfully working is instantly not available is devastating,” she stated. “We pray the recommended drugs to fight his malignancy will be available when it’s time for Nate’s next treatment. And we hope that in the future no more families have to go through the tension of wondering whether verified, lifesaving treatments will be out of reach if they need it the many.”Speaking at the news meeting, Hamburg stated: “There are way too many families like the Stuckeys who be concerned they don’t have the medicine they need for his or her next treatment and so are understandably anxious about switching to a medication that may have significantly more side results or could 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 avoided since October 2011 when we made the decision 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 Sunlight Pharma Global FZE. The agency said in its news release that “short-term importation of unapproved international drugs is considered only in rare cases when there is a shortage of an authorized drug that is critical to sufferers and the shortage cannot be resolved in due time with FDA-approved drugs.” The shortages of methotrexate and Doxil are just the latest in a series of drug shortages which have existed for several years. In 2011, prescription drug shortages in the United States hit an all-period high. Last fall, some 200 drug shortages had been reported, compared to 178 in every of 2010, the FDA reported. Many of the scarce medicines are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are just given in hospitals and so are “absolutely vital,” Valerie Jensen, associate director of the FDA’s drug shortage program, said during a news meeting last September. Over fifty percent (54 percent) of shortages this year 2010 were because of quality problems, such as drug impurities. Some were caused by delays or manufacturing capacity complications, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said. Jensen also said the shortages have a tendency to occur in medicines that are not “economically attractive.” This could mean that only one company produces the drug, which makes it harder to find alternatives if the supply dries up. A lot of the problems are linked with generic drugs, health experts explained, because few manufacturers make them and profit margins aren’t as high as for brand-name medications still under patent security. On Oct. 31, 2011, President Barack Obama signed an executive purchase designed to help ease the medication shortages. The purchase directed the FDA to “do something” to prevent and decrease worsening prescription medication shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a statement: “ASH is motivated by the guidelines FDA is taking to ease drug shortages that have considerably affected so many patients with hematololgic malignancies under our members’ care. The actions announced today are consistent with the Society’s suggestions to FDA, Congress and the NATIONAL GOVERNMENT to increase the agency’s authority to prevent drug shortages by requiring producers to supply early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the specific activities announced today,” Keating added, “we also realize that these measures represent just some of a solution to a much larger problem. Furthermore to these steps, extra measures — such as developing a national medication registry and providing financial incentives to manufacturers to make a steady way to obtain generics — should be implemented to completely prevent shortages. Until a comprehensive solution is set up, treatment will be delayed and care will end up being rationed for critically ill patients.”

Leave a Reply