By JoNel Aleccia, Senior Writer, NBC News Food and Drug Administration officials have turned to Norway to help ease a shortage of injection drugs used to provide nutrition to critically ill premature babies and cancer patients who cant eat any other way. The agency said Wednesday it immediately will begin importing trace elements, potassium phosphate and sodium phosphate -- drugs used in total parenteral nutrition or TPN -- from a Norwegian plant affiliated with Fresenius Kabi USA LLC, based in Lake Zurich, Ill. Hospitals can start ordering the drugs today, said Valerie Jensen, associate director for the FDAs drug shortage program. That should start reversing a two-year shortage that has forced hospitals to ration the drugs that provide essential nutrients for patients who cant eat or drink by mouth, said Jay Mirtallo, past president of the American Society for Parenteral or Enteral Nutrition, or ASPEN. I think its huge. Its a great win for us, said Mirtallo. For too long, weve been limping along trying to feed our patients. Without adequate TPN drugs, tiny babies and other patients can develop severe side effects, including horrifying skin lesions and deficiencies that can demineralize their bones, leading to fractures, experts say. Some … Continue reading →

By JoNel Aleccia, Senior Writer, NBC News Food and Drug Administration officials have turned to Norway to help ease a shortage of injection drugs used to provide nutrition to critically ill premature babies and cancer patients who cant eat any other way. The agency said Wednesday it immediately will begin importing trace elements, potassium phosphate and sodium phosphate -- drugs used in total parenteral nutrition or TPN -- from a Norwegian plant affiliated with Fresenius Kabi USA LLC, based in Lake Zurich, Ill. Hospitals can start ordering the drugs today, said Valerie Jensen, associate director for the FDAs drug shortage program. That should start reversing a two-year shortage that has forced hospitals to ration the drugs that provide essential nutrients for patients who cant eat or drink by mouth, said Jay Mirtallo, past president of the American Society for Parenteral or Enteral Nutrition, or ASPEN. I think its huge. Its a great win for us, said Mirtallo. For too long, weve been limping along trying to feed our patients. Without adequate TPN drugs, tiny babies and other patients can develop severe side effects, including horrifying skin lesions and deficiencies that can demineralize their bones, leading to fractures, experts say. Some … Continue reading →

(Reuters) - U.S. health regulators on Wednesday approved a pair of GlaxoSmithKline Plc drugs to treat advanced melanoma - the deadliest form of skin cancer - in patients with specific genetic mutations. It also approved a diagnostic test to detect the mutations. The Food and Drug Administration said it approved the drugs, Tafinlar and Mekinist, to be used as single agents and not in combination after the medicines delayed tumor growth in separate clinical trials. After decades with virtually no progress in the fight against advanced melanoma and little to offer patients facing a virtual death sentence, Tafinlar and Mekinist mark the third and fourth new drugs approved by the FDA for metastatic melanoma in the past two years. Tafinlar, known chemically as dabrafenib, belongs to a class of cancer drugs called as BRAF inhibitors. Mekinist, known chemically as trametinib, inhibits a protein associated with cancerous tumors known as MEK. Tafinlar was approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist was approved to treat patients whose tumors express either the BRAF V600E or V600K gene mutations. About half of skin melanomas have a BRAF mutation. The FDA also approved the THxID BRAF test, … Continue reading →

29 May 2013 Last updated at 19:44 ET The global war on drugs is fuelling a hepatitis C pandemic causing millions of needless infections, the Global Commission on Drug Policy has warned. Repressive drug law enforcement is driving high rates of infection among injecting drug users, it said. Resources need to be redirected into treatment and prevention. The Commission estimated that of 16 million people worldwide who inject drugs, 10 million are living with hepatitis C. This puts them at risk of fatal and debilitating liver disease. The Global Commission called on governments to decriminalise drug use and provide schemes, such as those which give access to sterile needles, to halt the spread of the disease. "The war on drugs is a war on common sense. The group, which includes seven former presidents, ex-UN chief Kofi Annan and other world leaders, has previously linked the "failed" war on drugs with the spread of HIV. In its latest report it says in some countries with the harshest drug policies more than 90% of people who inject drugs are living with hepatitis C. Original post: War on drugs 'driving hep C pandemic' … Continue reading →

By Ben Hirschler and Bill Berkrot LONDON/NEW YORK (Reuters) - U.S. health regulators have approved two new GlaxoSmithKline drugs for treating advanced melanoma, in the latest sign that companies are having more success getting novel medicines to market. The Food and Drug Administration (FDA) gave the green light to Tafinlar and Mekinist late on Wednesday, bringing the tally of new drugs approved by the U.S. agency so far this year to 13, compared with 11 at the same stage in 2012. After 39 FDA approvals last year - a record only beaten in 1996 - the continuing healthy run-rate for so-called new molecular entities is fuelling investor hopes the industry may finally be pulling out of a long period of poor productivity. The FDA approved the two GSK drugs to be used as single agents against melanoma - the deadliest form of skin cancer - and not in combination after the medicines delayed tumor growth in separate clinical trials. GSK, however, hopes further trials now underway will prove there is an additional benefit from combining the treatments, potentially giving it an edge over Roche's rival melanoma medicine Zelboraf. After decades with virtually no progress in the fight against advanced melanoma … Continue reading →

Federal health regulators are allowing imports from overseas of critical intravenous drugs used to nourish premature infants, amid a shortage that has affected hospitals nationwide. The Food and Drug Administration said Wednesday new supplies of drugs used in total parenteral nutrition, a ubiquitous hospital staple, will be available to U.S. patients this week. The injectable formula is used to feed newborn infants, cancer patients and other vulnerable groups who are unable to eat or drink by mouth. "If they cannot eat anything by mouth they have to be provided intravenous nutrition or they'll starve to death in a very short period of time," said Jay Mirtallo, professor of clinical pharmacy at Ohio State University. While the formula is most critical for infants, he said that "we have patients from 2 years old to 90 years old who are on it." The solution contains trace drug ingredients, including potassium phosphate, which have been in short supply. FDA officials said they are temporarily allowing imports of those ingredients from a plant in Norway to ease shortages triggered by the shutdown of American Regent, the primary U.S. manufacturer. American Regent halted operations late last year to fix contamination issues uncovered by FDA inspectors. … Continue reading →