FDA Tries to Provide Availability of 2 Cancer Drugs

The U. S. Food and Drug Administration announced Tuesday what it known as a series of steps to guarantee the continued availability of vital cancer medicines that have experienced dangerously short supply. Among the drugs, methotrexate, is utilized in mixture with other medicines to combat — and perhaps cure — severe lymphoblastic leukemia (ALL), the most common kind of cancer in kids. It typically strikes kids aged 2 to 5.And another drug, Lipodox, will be temporarily imported from a pharmaceutical firm in India to help ease a shortage of the chemotherapy medication Doxil (doxorubicin), which is utilized to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is comparable in chemical make-up to Doxil; there are simply no generic variations of Doxil.”Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families looking forward to these products or anxious about their availability should now be able to get the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg said in a news launch. The FDA also said it was issuing recommendations to the drug industry that spell out detailed requirements for “both mandatory and voluntary notifications” to the agency of potential problems that could lead to a drug shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in stopping recurrence. Without the drug, a patient’s chance for a remedy is reduced while the risk of recurrence rises, oncologists stated. Some malignancy doctors had warned the other day that items of methotrexate could possibly be exhausted within two weeks. To offset the shortage of methotrexate, the FDA said Tuesday that it spent some time working with several drug producers to help maintain items to meet up all patient requirements. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the mind and spinal-cord) treatment of kids 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 currently manufactures methotrexate, has sped up additional supplies, producing 31,000 new vials of the drug — enough for several month’s supply. Those extra vials are being shipped Tuesday to hundreds of U. S. hospitals and treatment centers, the FDA stated. The FDA also noted that it continues to utilize other producers of methotrexate that 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, among the audio speakers was Sara Stuckey, mom of 6-year-outdated Nate Stuckey, who has been on methotrexate since he was identified as having ALL in 2009 2009. “It is hard enough to listen to your son or daughter has cancer, but to listen to that the treatment that’s successfully working is all of a sudden not available is devastating,” she stated. “We pray the recommended medicines to fight his cancer will be available if it is time for Nate’s next treatment. And we hope that in the future no more families need to go through the tension of wondering whether verified, 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 like the Stuckeys who worry they won’t have the medication they need for their next treatment and so are understandably anxious about switching to a medication that may have more side results or could be less effective. Clearly this is not suitable.” “We are making improvement,” Hamburg added. “There have been 195 medication shortages prevented in 2011 and 114 medication shortages avoided since October 2011 whenever we made the call for early notification” of potential shortages. As for the ovarian cancer medication Lipodox, the FDA said it’ll allow the short-term importation of the drug made by Sunlight Pharma Global FZE. The company said in its news release that “temporary importation of unapproved foreign drugs is known as only in rare cases when there is a shortage of an accepted drug that is critical to individuals and the shortage cannot be resolved in due time with FDA-approved medicines.” The shortages of methotrexate and Doxil are simply the latest in some drug shortages which have existed for quite some time. In 2011, prescription medication shortages in the United States hit an all-period high. Last fall, some 200 drug shortages have been reported, in comparison to 178 in every of 2010, the FDA reported. Most of the scarce medicines are injectables, such as cytarabine and cisplatin, used to take care of serious conditions such as for example 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. More than half (54 percent) of shortages this year 2010 were due to quality issues, such as medication impurities. Some were due to delays or manufacturing capability problems, while 11 percent had been caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said. Jensen also said the shortages tend to occur in medications that aren’t “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 complications are tied to generic drugs, health specialists explained, because few manufacturers make them and income aren’t as high for brand-name medications still under patent safety. On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order 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), stated in a statement: “ASH is encouraged by the actions FDA is taking to ease drug shortages which have considerably affected so many sufferers with hematololgic malignancies under our associates’ care. The measures announced today are consistent with the Society’s suggestions to FDA, Congress and the NATIONAL GOVERNMENT to broaden the agency’s authority to prevent medication shortages by requiring producers to supply early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the precise activities announced today,” Keating added, “we also recognize that these measures represent only some of a remedy to a much bigger problem. In addition to these steps, additional measures — such as for example developing a national medication registry and providing economic incentives to manufacturers to produce a steady supply of generics — should be implemented to permanently prevent shortages. Until a full solution is in place, treatment will end up being delayed and care will be rationed for critically ill sufferers.”