Category Archives: Drugs

WASHINGTON (AP) A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions. Reports of joint failure led the agency to halt studies of the drugs in 2010 before any of the medications could be submitted for U.S. approval. Pfizer Inc., Johnson & Johnson and Regeneron Pharmaceuticals have asked the FDA to lift the moratorium on testing of their drugs. The FDA will weigh the advice of its panel before making a final decision. "There's clearly a worrisome safety signal, but in spite of that, I think there's an unmet need in certain patient populations," said panelist Dr. Sherine Gabriel, of the Mayo Medical School in Rochester, Minn. Panelists noted that not all patients respond to medications currently on the market, like Aleve and aspirin. The experts also said that the drugs could prove useful in treating a variety of other chronic pain conditions for which there are few options. "Anything that has the hope of … Continue reading →

By Deborah Kotz, Globe Staff The US Food and Drug Administration has a long wish list of changes it is considering for approving new drugs and making more prescription medications available over-the-counter. In a meeting with several reporters that I attended on Wednesday, FDA Commissioner Dr. Margaret Hamburg said the agency is at the beginning of a process to determine how we can be more innovative to improve access to certain drugs while at the same time curtailing the overuse of others. Here are three initiatives on their agenda: 1. A new over-the-counter-plus approval: Try to envision many of the most commonly prescribed medications -- statins, high blood pressure pills, asthma inhalers, migraine drugs, and the EpiPen for allergic reactions -- going over-the-counter. You wouldnt need a prescription from your doctor if you ran out, just a brief discussion with your local pharmacist to make sure youre taking the drug appropriately. The FDA is considering instituting an OTC-plus designation to address common conditions that are undertreated, often because patients fail to get prescription renewals. When I asked whether birth control pills and other hormonal contraceptives would be added to this list, Hamburg avoided answering directly and said the plan was … Continue reading →

WASHINGTON (Reuters) - U.S. drug regulators are asking experts for advice on whether companies should restart clinical trials for painkillers that help people with osteoarthritis and other conditions, but can destroy joints. The U.S. Food and Drug Administration said these drugs, from the class of anti-nerve growth factors, represent a potentially significant and novel strategy for the treatment of pain," in a memo posted online on Thursday. However, the FDA put a hold on almost all clinical trials of the drugs in 2010 after nearly 500 people taking the drugs in studies had to have their joints replaced. Companies were allowed to keep testing the drugs in terminal cancer patients who had severe pain in their bones, since the benefits there may outweigh risks. Pfizer Inc, Regeneron Pharmaceuticals Inc and Johnson & Johnson are now pitching to resume wider trials, in what could be a multi-billion-dollar pain market. Outside advisers to the FDA will vote on Monday on whether there is a way for trials to move forward, perhaps by limiting the drugs to lower doses, or to only certain conditions where people have fewer treatment options. The drugs have been studied for common conditions like low back pain and … Continue reading →

WASHINGTON (AP) Some of the world's largest drugmakers will face an uphill battle next week in their bid to revive a class of experimental arthritis drugs that have been sidelined by safety concerns for nearly two years. The Food and Drug Administration says there is a clear association between the nerve-blocking medications and incidences of joint failure that led the agency to halt studies of the drugs in 2010. However, the agency also notes that those side effects were less common when the drugs were used at lower doses, potentially leaving the door open for future use. The agency released its safety analysis ahead of a public meeting next week where outside experts will discuss the drugs' safety. On Monday, Pfizer Inc., Johnson & Johnson and Regeneron Pharmaceuticals will make their case to continue studies of the drugs, with safety precautions to protect patients. The request to restart testing is unusual, since drugmakers often abandon research on experimental drugs that appear to have safety issues. However, with more than 50 million U.S. adults diagnosed with arthritis one in five the potential multibillion dollar market opportunity may be too big to ignore. If the drugs eventually win FDA approval though, they … Continue reading →

Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators. In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March. The goal is to ensure people take drugs as needed, while still understanding safety issues. Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States. About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention. The FDA said about a third of those with high blood pressure stop taking their medication. The problem with making these drugs available without a prescription is that many require patients to understand complex aspects of their disease, or exactly … Continue reading →

WASHINGTON (Reuters) - Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators. In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March. The goal is to ensure people take drugs as needed, while still understanding safety issues. Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States. About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention. The FDA said about a third of those with high blood pressure stop taking their medication. The problem with making these drugs available without a prescription is that many require patients to understand complex aspects of their … Continue reading →

Only a third of illegal drugs smuggled from Latin America into the United States are seized by authorities because of a lack of resources, the head of the US Southern Command said Wednesday. The one-third figure is based on an estimate from intelligence services that monitor ships and aircraft used for smuggling, General Douglas Fraser told reporters. He acknowledged that a more exact estimate would be difficult. "Do we have enough interceptor vessels for the targets that we have," Fraser asked. "Right now, we do not." Planes taking off with illegal drugs from South America land mainly in Honduras, but also in areas of Panama, he said. Most of the drugs are transported on ships and submersible vessels, which unload their cargo in Central America and Mexico. From there, it continues overland into the United States, Fraser said. About 90% of the cocaine reaching the United States passes through Central America and Mexico, he said. Central American countries simply do not have the air forces capable of intercepting all the drug flights landing in their territory, he said. At times, he said, "We know where they are and we could have intercepted if we had a vessel available." The problem … Continue reading →

WASHINGTON (AP) -- An experimental technique seems to be freeing some kidney transplant patients from having to take anti-rejection drugs. Researchers transplanted certain cells from the kidney donor's bone marrow along with the new organ. Five of eight transplant recipients who tried the method so far were off immune-suppressing medication up to 2 years later, the researchers reported Wednesday. The preliminary results were considered important enough to be published in the journal Science Translational Medicine even though the study still is under way, because the technique worked for patients who didn't have well-matched or related donors. The idea is that if a sort of twin immune system takes root and lasts, it can allow the patient's body to accept the foreign organ and not attack it, said study co-author Dr. Suzanne Ildstad of the University of Lousville. Scientists call it chimerism. "The most reliable indicator of really being successful at taking someone off immune-suppressing drugs is durable chimerism," says Ildstad, who teamed with doctors at Chicago's Northwestern Memorial Hospital for the research. Transplant recipients usually must take multiple immune-suppressing pills for life to prevent rejection of their new organ. Those drugs cause lots of side effects, such as raising the … Continue reading →

WASHINGTON (AP) Some of the most widely used prescription drugs, including those to treat cholesterol and high blood pressure, could be available over the counter under a new proposal being weighed by government regulators. Food and Drug Administration officials said Wednesday they are considering waiving prescription requirements for certain drugs used to treat ailments like diabetes, asthma and migraine. Driving the move is a wave of computer technology, including touch-screen kiosks found in pharmacies, designed to help patients self-diagnose common diseases. FDA regulators told reporters that easing access to obtain certain medications could help address undertreated epidemics like diabetes. Of the more than 25 million Americans with diabetes, an estimated 7 million are not diagnosed and therefore do not receive treatment. Diabetes is a leading cause of heart disease and stroke. "These are discussions that need to start happening as we think about people's health needs and how to improve access," said FDA Commissioner Dr. Margaret Hamburg. The over-the-counter switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications. After years of high-profile drug-safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting … Continue reading →

Gibraltar does not appear to be anywhere near close in getting to grips with this serious social issue. In a social perspective we are experiencing very bad times. This is a disturbing and dangerous period where drug trends are ever changing with high levels of drug abuse now affecting a sizable part of the community, particularly the younger generation! Crime is up to unprecedented levels, the vast majority of crimes are drug or alcohol related. Most worryingly is the fact that it's the next generation of Gibraltarians who are going to feel the brunt of today's excess drug and alcohol abuse, more so, because of the failed and ineffective anti-drug mechanisms put in place to combat this serious problem? Drug arrests and court cases keeping rising! Last week both the supreme and magistrates courts were hard at it, administering justice sending defendants away to prison on lengthy custodial sentences for possession and the supply of illegal drugs, these defendant were all relatively young people. Although there were few surprises with police activity, when you think the RGP had another bumper year where drug arrests are concerned with record highs! Yet as I have said countless times, encouraging as these police … Continue reading →