Category Archives: Drugs

The Food and Drug Administration said it was looking more closely at the way generic companies made extended-release drugs after it found one such medicine failed to work as well as its brand-name counterpart. A conveyor belt at Teva Pharmaceuticals in Israel, which markets a generic version of Wellbutrin XL. The finding is a rare departure for the agency, which for years has insisted that generic drugs are just as effective as their brand-name versions. The drug, a 300-milligram dose of bupropion, was manufactured by Impax Laboratories and was intended to mimic the popular antidepressant, Wellbutrin XL. But soon after it was introduced in 2006, patients who switched to it from Wellbutrin began complaining that their depression had returned. Impax and Teva Pharmaceuticals, which marketed the drug, have stopped selling the 300-milligram dose. Although regulators have said the episode appears to be limited to one dosage level of a single drug, an F.D.A. official said in October that the agency was now looking more closely at the techniques generic drug makers used to make the extended-release drugs. This has actually prompted us to change our policy, Dr. Gregory P. Geba, the director of the F.D.A.s office of generic drugs, said … Continue reading →

Drugs like Pfizer Inc. (PFE)s Lipitor and healthier diets containing fewer trans fats have led to lower cholesterol levels in the U.S. in the past two decades, even as obesity rates soared, a study found. Total cholesterol declined 5 percent on average between 1988 and 2010, while bad cholesterol, or LDL, dropped 10 percent and good cholesterol, or HDL, rose 3.4 percent, according to research published today in the Journal of the American Medical Association. The number of people using cholesterol-lowering medicines rose to 16 percent in 2007-2010 from 3 percent in 1988-1994. High cholesterol is a major risk factor for heart disease and stroke, according to the American Heart Association. Less smoking, better diets and widely prescribed cholesterol-lowering medicines have all helped to lower levels in the U.S., the authors said. About one-third of American adults are obese. Even though weve had this increase in obesity, some of those negative consequences have been balanced by the reductions of smoking and trans fats in our diet, said Donna Arnett, president of the Dallas-based American Heart Association, in a telephone interview yesterday. In the U.S., we have been improving our cholesterol levels and improving our cardiovascular health and thats good news. … Continue reading →

MedicalRF.com/Corbis A mutation, called Fragile X, on the X chromosome can cause retardation and autism. Seen here, a microscopic visualization of X chromosomes. Roger Diehl, a college freshman with Asperger's and depression, and his mother, Sita Diehl, answer questions about what parents and education specialists can do to help kids with learning disabilities or mental illness make a strong transition to college. Read the Q&A Scientific researchers can spend years in the lab on obscure topics, like how a sea slug remembers or how a fruit fly sees color. But every now and then, a basic scientist makes a discovery that changes human lives. Mark Bear, who directs the Picower Institute for Learning and Memory at MIT, is one of those basic scientists. He's discovered a system in the brain that could change the lives of thousands of people with the genetic disorder known as Fragile X Syndrome. Fragile X is a mutation on the X chromosome that can cause mental retardation and autism. Until now, there has been no treatment. But Bear discovered that the mutation responsible for Fragile X appears to disrupt a system in the brain that regulates synapses the connections between brain cells. He says the … Continue reading →

By Val Brickates Kennedy, MarketWatch BOSTON (MarketWatch) Two more drugs have linked to a deadly outbreak of fungal meningitis around the country, the Centers for Disease Control reported Monday. The CDC said it has received reports that a patient with possible fungal meningitis, an infection of the protective membranes of the brain and spinal cord, was recently injected with the steroid drug triamcinolone acetonide. In addition, two transplant patients who received the medication cardioplegic solution have been diagnosed with fungal infections. All of three infections involve the fungus aspergillus. The agency said it is investigating whether the two drugs were manufactured by New England Compounding Center, or NECC, which has been implicated in the ongoing outbreak. The company recalled all of its products from the market on Oct. 6. Why do some some people explode at little annoying things and others don't, like dealing with customer-service people or someone who cuts in line at the grocery store? Elizabeth Bernstein and Weill Cornell psychology professor Stephen Josephson discuss. Photo: AP. Earlier this month, reports surfaced that patients injected with the steroid methylprednisolone acetate had developed a rare form of meningitis associated with fungus aspergillus. Investigators suspect the cases were caused by … Continue reading →

The New England Compounding Center recalled all its products earlier this month following an outbreak of fungal meningitis. STORY HIGHLIGHTS (CNN) -- More issues have been reported with drugs from a Massachusetts compounding pharmacy linked to a deadly multistate outbreak of fungal meningitis, federal officials said Monday. Fifteen people have died from the non-contagious meningitis associated with injections of a contaminated steroid produced by the New England Compounding Center. As part of the ongoing investigation into the center, a patient with possible meningitis has been identified who received injection of another NECC product, triamcinolone acetonide, the Food and Drug Administration said. And fungus infections from Aspergillis, one fungus linked to the meningitis outbreak, were reported in two transplant patients who received cardioplegic solution from NECC, the FDA said. Cardioplegic solution is used to induce paralysis of the heart during open-heart surgery. The other fungus linked to the meningitis outbreak is Exserohilum, which the CDC says may not be easily detectable. A patient with a negative fungal test is not in the clear, officials have said. The NECC on October 6 announced a recall of all its products. The FDA said Monday it has not confirmed the three infections were caused … Continue reading →

The New England Compounding Center recalled all its products earlier this month following an outbreak of fungal meningitis. STORY HIGHLIGHTS (CNN) -- More issues have been reported with drugs from a Massachusetts compounding pharmacy linked to a deadly multistate outbreak of fungal meningitis, federal officials said Monday. Fifteen people have died from the non-contagious meningitis associated with injections of a contaminated steroid produced by the New England Compounding Center. As part of the ongoing investigation into the center, a patient with possible meningitis has been identified who received injection of another NECC product, triamcinolone acetonide, the Food and Drug Administration said. And fungus infections from Aspergillis, one fungus linked to the meningitis outbreak, were reported in two transplant patients who received cardioplegic solution from NECC, the FDA said. Cardioplegic solution is used to induce paralysis of the heart during open-heart surgery. The other fungus linked to the meningitis outbreak is Exserohilum, which the CDC says may not be easily detectable. A patient with a negative fungal test is not in the clear, officials have said. The NECC on October 6 announced a recall of all its products. The FDA said Monday it has not confirmed the three infections were caused … Continue reading →

Health officials have now identified two more drugs that may be linked to the recent outbreak of fungal meningitis. All meningitis cases were previously tied to methylprednisolone acetate a steroid injection used as treatment for back pain. Two additional cases of fungal infections in people's joints were linked with the same drug. But now, one case of suspected meningitis has been linked to a drug called triamcinolone acetonide, another type of steroid injection, according to the Food and Drug Administration. Both drugs were made by the New England Compounding Center in Framingham, Mass. In addition, two patients undergoing organ transplants developed fungal infections after surgeries that used a NECC drug. The drug, called cardioplegic solution, is administered to paralyze the heart during surgery. It is not clear whether the fungal infections seen in these two patients were caused by the cardioplegic solution, or by something else, the FDA noted. So far, the outbreak has affected 214 people in 15 states, and caused five deaths, according to the Centers for Disease Control and Prevention. Patients who received any injectable drug made by NECC including drugs used in eye surgery or who received cardioplegic solution should be alerted about their potential risk … Continue reading →

CHICAGO/NEW YORK (Reuters) - Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis. The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. It also said two transplant patients were infected with the rare fungus linked to the meningitis outbreak after receiving a heart drug also made by the New England Compounding Center (NECC) of Framingham, Massachusetts. Nine more people have been diagnosed with fungal meningitis linked to possibly tainted vials of the injected steroid methylprednisolone, bringing the number of cases to 212, according to the U.S. Centers for Disease Control and Prevention (CDC). A Tennessee woman among these cases filed a lawsuit on Monday against NECC seeking $15 million in damages. The patient identified by the FDA as potentially having meningitis received an injection for pain of the steroid triamcinolone, also supplied by NECC. The FDA said its investigation of that patient and the two who received the … Continue reading →

The FDA is urging doctors who administer any injectable product, drug used in eye surgery or cardiac solution, to contact their patients out of an abundance of caution. NBC's Lisa Myers reports. By Maggie Fox, NBC News Two more drugs have been implicated in the ongoing outbreak of fungal meningitis linked to contaminated pain injections, federal health officials said Monday. Both come from the same pharmacy, New England Compounding Center, that distributed the steroids suspected of sickening at least 214 people and killing 15 of them, the Food and Drug Administration said in a statement. One is a steroid called triamcinolone acetonide and another is a product used during heart surgery. While the FDA hasnt confirmed that the two products are to blame, its issued a warning. A patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA, the agency said in a statement. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product. Both can be injected into the spine. The FDA didn't … Continue reading →

NEW YORK, NY--(Marketwire - Oct 15, 2012) - The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on MannKind Corporation ( NASDAQ : MNKD ) and Dendreon Corporation ( NASDAQ : DNDN ). Access to the full company reports can be found at: http://www.ParagonReport.com/MNKD http://www.ParagonReport.com/DNDN Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trials, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical needs. Hamburg has said that the FDA needs to take into account the needs of people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs. "A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for … Continue reading →