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Tag: FDA

  • New Hepatitis C Treatment Approved in the U.S.

    The U.S. Food and Drug Administration (FDA) today announced that a new treatment for hepatitis C has been approved.

    The drug, marketed as Sovaldi, is now approved for the treatment of chronic hepatitis C virus (HCV) – the second such drug in the past month to be approved by the FDA. HCV is a chronic viral infection that causes inflammation of the liver. The disease can cause cirrhosis of the liver or even liver failure in some cases. Sovaldi stands out as the first drug approved to treat HCV without interferon also being necessary.

    “Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Dr. Edward Cox, director of the Office of Antimicrobial Products at the FDA.

    Sovaldi was approved this week following six clinical trials of the drug. During the trials, nearly 2,000 patients with HCV (and some with HIV) were given Sovaldi. The trials demonstrated that Sovaldi is effective in treating HCV and that even patients with liver cancer can use the drug.

    The drug works by blocking a protein that HCV needs to replicate itself and is meant to be used as part of an antiviral treatment program involving other drugs. Sovaldi is most likely to be used in combination with ribavirin and peginterferon-alfa.

    Sovaldi is one of the FDA’s “breakthrough therapy” drugs, a designation meaning a drug provides a substantial improvement over existing treatments for life-threatening diseases. Drugs designated as such can be fast-tracked for FDA approval, and Sovaldi is the third breakthrough therapy drug to be approved.

  • Bent-Penis Drug Approved by the FDA

    Bent-Penis Drug Approved by the FDA

    The U.S. Food and Drug Administration (FDA) today approved a drug for the treatment of Peyronie’s disease, a medical condition that causes severe curvature of the penis. The drug, branded as Xiaflex, is the first FDA-approved medication for the treatment of the disease.

    “Today’s approval expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option,” said Dr. Audrey Gassman, deputy director of Bone, Reproductive and Urologic Products at the FDA.

    Peyronie’s disease causes an abnormal bend in the penis while erect, and is caused by scar tissue that develops under the skin. The condition can cause sexual dysfunction, erectile dysfunction, shortening, and/or pain for men affected with it.

    Treatment with Xiaflex involves multiple treatment cycles in which the drug is injected directly into a patient’s penis, which then undergoes what the FDA refers to as “a penile modeling procedure performed by [a] health care professional.” The drug is already FDA approved for the treatment of Dupuytren’s contracture, a disease that can cause patients to have difficulty straightening their fingers.

    The FDA approval comes after two clinical trials that were found to significantly reduce penile curvature in more than 800 men over the course of one year.

    Though approved, Xiaflex does carry the risk of “serious adverse reactions,” including possible penile fracture. Due to the risks, the drug may only be prescribed for the treatment of Peyronie’s under a restricted program through a Risk Evaluation and Mitigation Strategy administered by a doctor with urological disease treatment experience.

  • J&J Company to Pay $1.25 Million Over Expiration Dates

    The U.S. Food and Drug Administration (FDA) today announced that it has settled a civil penalty case against Johnson & Johnson company Advanced Sterilization Products (ASP). ASP has agreed to pay $1.25 million over misbranded products that it distributed.

    Two ASP executives have also settled with the FDA over the matter. ASP President Bernard Zovighian has agreed to pay $30,000 and ASP Vice President of Quality and Regulatory Compliance Richard Alberti will pay $20,000.

    The case involves allegations that ASP knowingly shipped its Sterrad Cyclesure 24 Biological Indicators with inaccurate expiration dates. The FDA in 2012 learned that ASP had determined in a study that it did not have sufficient evidence to support its stated 15-month shelf life for the product. A recall was issued shortly after the FDA’s findings were released and ASP has since shortened its stated shelf life for the product.

    “Accurate expiration dates are critical to ensuring product integrity,” said Steve Silverman, director of the Office of Compliance in the Center for Devices and Radiological Health at the FDA. “ASP’s actions violated the law and put patients at unnecessary risk for infection. The FDA is committed to enforcing the law and protecting the public from the potential harms associated with inaccurate product information.”

    This settlement comes less than one month after a different Johnson & Johnson subsidiary settled a different lawsuit and agreed to pay $2.5 billion. That settlement involved DePuy Orthopaedics’ knowledge that their hip replacements could release small metal particles into the bodies of patients.

  • FDA Raid Nabs $2 Million in Banned Dietary Supplements

    The U.S. Food and Drug Administration (FDA) today announced that it last week led a raid on Norcross, Georgia dietary supplement manufacturer Hi-Tech Pharmaceuticals. During the raid, U.S. Marshals seized more than 1,500 cases of weight loss products. The goods, along with more than 1,200 pounds of raw manufacturing materials and substances, have an estimated retail value of around $2 million.

    According to the FDA, the supplements being manufactured by Hi-Tech contained 1,3-Dimethylamylamine HCL (DMAA) – an unapproved food additive in the U.S. The FDA considers the substance to be unsafe for consumption, as it has been linked to high blood pressure and other cardiovascular issues. The substance could, according to the FDA, be even more dangerous when used with caffeine.

    The FDA stated that it did find raw DMAA ingredients in bulk at Hi-Tech’s manufacturing facilities.

    “This company has a responsibility to ensure its products are safe for distribution and human consumption,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

    The FDA’s raid was conducted following a an investigation that began in October. The agency found that 11 products manufactured by Hi-Tech contained DMAA, including brands with names such as Black Widow, Yellow Scorpion, Fastin, and Liprodrene. On November 1, the FDA issued an order to hold the supplement products until the seizure took place.

  • Epilepsy-Treating Brain Implant Approved by FDA

    The U.S. Food and Drug Administration (FDA) today approved a brain implant designed to treat epilepsy. The implant is now approved for use in the U.S. to help reduce the frequency of epilepsy-related seizures for patients who haven’t responded to seizure medications.

    The implant is called the RNS System and is manufactured by a company called Neuropace. I consists of a neurostimulator that is implanted within a patient’s skull, then connected to two electrodes that are placed on or inside a patient’s brain in areas where doctors believe epilepsy seizures occur. The neurostimulator then provides a normalizing burst of electrical stimulation when it detects electrical activity consistent with an oncoming seizure.

    “The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms,” said Christy Foreman, director of the Office of Device Evaluation at the FDA.

    Approval for the device was based on a three month clinical trial in which 191 epilepsy patients who had not responded to seizure medications were implanted with the device. Patients participating in the trial were shown to have n average of around 38% fewer seizures each month.

    Abnormal electrical signals in the brain are known to cause epilepsy. People with the disorder often suffer from odd physical behaviors or seizures. According to the FDA around 3 million people in the U.S. suffer from epilepsy, and almost 200,000 Americans will be diagnosed each year.

  • Study: Most Herbal Supplements Contain No Herbs

    The New York Times noted a study last week from a Canadian research team claiming roughly three out of four herbal supplements contain little more than weeds or powdered rice.

    The research team used a test called DNA barcoding, which has previously been used to uncover fraudulent seafood labeling, on 44 bottles of herbal supplements from 12 companies they, upon request, refused to name. Their findings have been published in the BMC Medicine journal.

    Entire bottles of supplement were either diluted or entirely replaced by soybean, wheat, or rice filler. The team hopes their results will provide evidence of the questionable practices inside the herbal supplement industry, which rakes in a solid $5 billion from Americans alone.

    Of the 44 tested bottles, one in three had a completely different plant in place of the one advertised. Even more had unlisted ingredients: two bottles labeled as St. John’s wort contained none at all, with one containing rice and the other a powerful Egyptian laxative called Alexandrian senna.

    David Schardt, a senior nutritionist from an advocacy group, the Center for Science in the Public Interest, said regarding the research that “This suggests that the problems are widespread and that quality control for many companies, whether through ignorance, incompetence or dishonesty, is unacceptable… Given these results, it’s hard to recommend any herbal supplements to consumers.”

    Meanwhile, the supplement industry doesn’t seem to see a problem with their business practices. Dr. Stefan Gafner, chief science officer with the American Botanical Council (which supports herbal supplement use) said “Over all, I would agree that quality control is an issue in the herbal industry, but I think that what’s represented here is overblown. I don’t think it’s as bad as it looks according to this study.”

    Attempting to police the supplement industry presents difficulties for the Food & Drug Administration, which requires that all companies test the products they sell to guarantee safety. But since it’s an honor system, people (and the companies that employ them) lie all the time.

    Spokesman Duffy MacKay with the Council for Responsible Nutrition (which is a trade group for the supplement industry) tried to lay the problem on the FDA, saying “we need a strong regulator enforcing the full force of the law. FDA resources are limited, and therefore enforcement has not historically been as rigorous as it could be.”

    FDA spokeswoman Shelly Burgess said that, in spite of regulation, many companies are ignoring the rules anyway. “We are seeing a very high percentage — approximately 70 percent — of firms’ noncompliance, and we are very active in taking enforcement actions against such violations,” she asserts.

    A professor of obstetrics, gynecology and reproductive medicine from Stony Brook named Dr. David A. Baker conducted a similar study last year on black cohosh supplements he purchased from a variety of online and local stores. Barcoding tests on Baker’s supplements showed that over 25 percent of them contained no black cohosh, but a ground-up Chinese ornamental plant.

    If you want to read more, the Times piece is found here; it has a great section explaining how the DNA barcoding process works.

    [Image via Wikimedia Commons]

  • FDA Approves New Seizure Medication

    FDA Approves New Seizure Medication

    The U.S. Food and Drug Administration (FDA) today announced that it has approved a new medication for seizures associated with epilepsy.

    The drug, branded Aptiom by Sunovion Pharmaceuticals, is now approved for the treatment of “partial” seizures of the type seen in epilepsy patients. The drug was approved following three clinical trials that showed the drug is effective at reducing the frequency of seizures in patients with epilepsy.

    “Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments,” said Dr. Eric Bastings, acting director of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “It is important we continue to make new treatment options available to patients.”

    Epilepsy is a brain disorder that can cause electrical disturbances in the brain. People with epilepsy can suffer from odd behaviors or movements, or even sometimes suffer seizures that are caused by intense nerve cell activity in the brain. Serious seizures can even lead to convulsions or loss of consciousness. The FDA estimates that around 200,000 Americans will experience epilepsy each year.

    Aptiom has many of the same side-effects that other anti-seizure medications have, including headache, nausea, drowsiness, dizziness, double-vision, vomiting, and fatigue. The FDA also warns that it could cause suicidal thoughts for a smaller subset of patients.

  • NY Mayor Bloomberg Sounds Off on Trans Fat Ban

    Earlier today the U.S. Food and Drug Administration (FDA) proposed a new classification for trans fats that would essentially ban partially hydrogenated oils from being used in food.

    While the proposal has reignited a national debate government regulation and public health, other parts of the U.S. have had trans fat bans for years. As with many public health laws, New York led the way with a limited ban on trans fats that was passed back in 2006. Philadelphia months later followed with its own trans fat ban. Many larger U.S. cities now ban trans fats from use in local restaurants.

    Having led the charge for the trans fat ban, New York Michael Bloomberg took today’s news as an opportunity to brag about his city’s foresight in leading the way to a trans fat ban.

    “Seven years ago we became the first city in the nation to prohibit restaurants from using trans fats,” said Bloomberg. “Since then, at least 15 states and localities have followed suit and banned trans fats – and more than ten fast food chains have eliminated trans fats entirely. Today, we’re greatly encouraged that the FDA proposed measures that would virtually eliminate the artery-clogging and unnecessary ingredient from our nation’s food supply.”

    The mayor went on to point out other public health initiatives that New York has led the way on. The city was one of the first to ban smoking in restaurants, a health measure that has now spread widely throughout the U.S. The city was also first to require restaurants to provide calorie information for their menus, something that is now mandated in the U.S.

    New York’s latest high-profile health initiative was a ban on large sugary drinks in restaurants. That mandate was struck down by a New York Appeals Court back in July.

    “Our prohibition on trans fats was one of many bold public health measures that faced fierce initial criticism, only to gain widespread acceptance and support,” said Bloomberg. “Smoke-free restaurants and bars are now the norm in much of the country and increasingly around the world. Calorie counts are now required at all restaurants chains in the United States. The groundbreaking public health policies we have adopted here in New York City have become a model for the nation for one reason: they’ve worked. Today, New Yorkers’ life expectancy is far higher than the national average, and we’ve achieved dramatic reductions in disease, including heart disease. The FDA deserves great credit for taking this step, which will help Americans live longer, healthier lives.”

  • FDA: Trans Fats Unsafe, to be Banned in Foods

    The U.S. Food and Drug Administration (FDA) today announced its intention to classify trans fats known as partially hydrogenated oils as not “generally recognized as safe” for use in food. The classification is set to go into effect after 60 days, after which the trans fats would be classified as “food additives” and could not be used in food. If that happens, the FDA states, food manufacturers would have an “adequate” amount of time to remove the trans fats from their product formulas.

    Trans fats, specifically partially hydrogenated oils, are used in a variety of processed foods in the U.S. Though many U.S. food manufacturers in recent years have reduced the amount of trans fats in their foods, the FDA has now determined that the fats pose a public health risk.

    “While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern,” said Dr. Margaret Hamburg, FDA Commissioner. “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”

    In making its decision, the FDA pointed to an Institute of Medicine report that states there is no safe level of consumption for trans fats and that the fats have no known health benefit. Nutrition labels in the U.S. were required to list trans fat starting in 2006.

    “One of the FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe,” said Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA. “Food manufacturers have voluntarily decreased trans fat levels in many foods in recent years, but a substantial number of products still contain partially hydrogenated oils, which are the major source of trans fat in processed food.”

  • Johnson & Johnson to Pay $2.2 Billion Over Risperdal Claims

    The U.S. Department of Justice and the U.S. Food and Drug Administration (FDA) today announced that Janssen Pharmaceuticals has plead guilty over the misbranding of the drug Risperdal. Janssen and its company, Johnson & Johnson, will pay a total of $2.2 billion to settle the matter.

    Around $485 million of the amount will be paid in the form of a criminal fines and forfeitures, while the other $1.72 billion is part of civil case settlement with the U.S. federal and several state governments. In addition, the company will also have to comply with a corporate integrity agreement put together by the U.S. Department of Health and Human Services’ Office of the Inspector General.

    “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Eric Holder, U.S. Attorney General. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

    The drug in question, Risperdal, has been approved by the FDA for the treatment of schizophrenia and the short-term treatment of manic episodes in those with Bipolar Disorder. Janssen has admitted to marketing the drug to doctors for the treatment of agitation associated with elderly dementia – a use for which Risperdal is not FDA approved.

    The Justice Department claims that both Janssen and Johnson & Johnson downplayed the increased risk of stroke that the drug could cause in elderly patients and that they paid kickbacks to doctors who prescribed Risperdal. The companies had received multiple warnings about their marketing of Risperdal.

    The criminal investigation into Janssen’s Risperdal marketing practices began after a whistle-blower complaint was filed with the FDA.

    “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said Dr. Margaret Hamburg, FDA Commissioner. “The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective. Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”

  • FDA Proposes New Pet Food Regulations

    FDA Proposes New Pet Food Regulations

    Though many people see their pets as members of the family, the U.S. does not regulate pet food as strictly as it does people food. Recent pet food recalls have demonstrated just how Regulations could be tightened, however, if a newly proposed rule by the FDA is put into place.

    The FDA today issued a proposed rule to improve the safety of food for animals by preventing foodborne illness from spreading through such products. The rule would require animal food manufacturers to write up a “formal plan” and develop procedures to prevent foodborne illnesses in their products, as well as come up with a plan for dealing with any such situations that arise. In addition, animal food manufacturers would have to follow the FDA’s good manufacturing practices at its facilities. Manufacturers are are not currently required to follow such guidelines, which include facility sanitation provisions.

    “The FDA continues to take steps to meet the challenge of ensuring a safe food supply,” said Dr. Margaret Hamburg, commissioner of the FDA. “Today’s announcement addresses a critical part of the food system, and we will continue to work with our national and international industry, consumer and government partners as we work to prevent foodborne illness.”

    The new rule will be open for public comment for four months. The rule was issued under the Food Safety Modernization act to protect not only pets but humans as well, who are susceptible to foodbourne illnesses through the handling of food for animals.

  • Hydrocodone Put Up For Reclassification By FDA In Crackdown

    Hydrocodone has long been on the DEA’s list of drugs that they’d like to see reclassified, which would make it harder to obtain; now, the FDA has agreed, after a ten-year battle by the DEA, to recommend Vicodin and other hydrocodone-based drugs as a Schedule II substance.

    “While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Janet Woodcock of the FDA said.

    What does that mean, exactly? For starters, prescription refills will be limited to a 90-day supply rather than the previous five refills within six months, and in some states only a doctor can write a prescription rather than a nurse practitioner. Many doctors are loathe to give a patient a Schedule II drug because of the potential for addiction. That, according to Edward Michna–an assistant professor at Harvard Medical School–will make things harder for patients who genuinely need the pain medication.

    “You have to consider the secondary, unintended consequences: patients who are legitimate users who may lose access, or be restricted,” Michna said. “It’s all a balance.”

    However, the FDA has seen the widespread, devastating effects that prescription drug addiction can have, and said in a statement that in some states, it has become an epidemic. The group is recommending the classification change by the end of the year.

    “By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products,” Woodcock said.

    Image: Wikimedia Commons

  • F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers

    On Thursday, the Food and Drug Administration recommended significantly tighter controls on how doctors prescribe commonly used painkillers such as Vicodin and Lortab.

    The recommendation comes amidst growing concern over abuse of prescription painkillers. It’s a debate that has raged for almost a decade, and the most recent measures focus on drugs containing the narcotic hydrocodone in combination with over-the-counter painkillers such as acetamenophin and aspirin.

    The proposed changes would reduce the number of refills patients could get before needing to go back to their doctor for a new prescription. Currently, patients can refill prescriptions for this class of drugs five times over a period of six months. The new regulations would reduce that amount of time by half, to 90 days.

    Additionally, these prescriptions could no longer be called in to pharmacies by doctors. Patients would be required to actually take the physical prescription to their pharmacy.

    The new restrictions would come about due to a reclassification of painkillers containing hydrocodone. They are currently classified as “Schedule III” drugs. Under the new regulations, they would be “Schedule II,” a classification reserved for drugs with the highest potential for abuse that can be legally prescribed.

    The more powerful painkiller oxycodone is already a Schedule II drug, as are medications such as Adderall and Ritalin.

    Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, says the new regulations could take effect as soon as early 2014.

    Detractors claim the new regulations will make it difficult for patients in need of painkillers to obtain the drugs they need. They cite the added trouble and expense involved with more frequent doctor visits. Doctors’ and pharmacy organizations, such as the American Medical Association, have long fought against Drug Enforcement Agency recommendations for heightened controls on these drugs. According to a statement on the FDA’s website, the DEA originally asked for this reclassification in 2009.

    Robert Twillman is Director of Advocacy and Policy for the American Academy of Pain Management: “The concern we have is that it may unintentionally make access for people with pain even more of a challenge than it is now. This could necessitate millions more office visits, with attendant costs approaching a billion dollars a year.”

    But Dr. Woodcock and other supporters of the increased controls believe it’s a risk we have to take in order to curb the widespread abuse of prescription painkillers.

    “These are very difficult tradeoffs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

    According to the Centers for Disease Control, nearly three out of four prescription drug overdoses are caused by prescription painkillers. More of these overdoses occur in men than in women, but alarming statistics show that the gap is closing. The percentage increase in deaths from prescription painkiller overdose among women increased 400% in the past decade, while for men that rate was 265%.

    Image via Free Digital Photos

  • FDA On-Track to Eliminate CFC Inhalers This Year

    The U.S. Food and Drug Administration (FDA) today announced that it is nearing the end of its decade-spanning elimination of all medical inhalers that contain chlorofluorocarbons (CFCs). Such inhalers will be entirely phased out by the end of 2013.

    The agency was tasked with eliminating the products as part of the Montreal Protocol treaty formed in 1987 to protect the Earth’s ozone layer by eliminating substances believed to contribute to its destruction. CFCs were once widely used as propellants in a variety of consumer products, but have been just as widely phased out after evidence emerged that the compounds could contribute to ozone depletion.

    “CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine,” said Dr. Badrul Chowdhury, director of the Pulmonary, Allergy, and Rheumatology Products division at the FDA. “For more than two decades, the FDA and EPA have collaborated to phase-out CFCs in inhalers – a process that included input from the public, advisory committees, manufacturers, and stakeholders.”

    According to the FDA, only two medical inhaler products that use CFCs are still on the market in the U.S.: Combivent Inhalation Aerosol and Maxair Autohaler. Both of the products are used to treat asthma or chronic obstructive pulmonary disease (COPD), and patients using the products are urged to talk to a doctor about changing their medication before the products become unavailable after December 31.

    “The EPA and FDA’s partnership has facilitated a safe, gradual transition to CFC-free inhalers in the United States,” said Drusilla Hufford, director of the Stratospheric Protection division at the EPA. “This action is an important contribution to the global effort to repair the Earth’s protective ozone layer and save millions of lives through the prevention of skin cancer.”

  • Diet Coke’s Artificial Sweetener Causes Sales Drop

    There have been a lot of growing concerns lately over the artificial sweeteners used in Diet Coke and other foods and beverages. We’ve heard for years about how certain artificial sweeteners can cause cancer and heart disease and contributes to obesity (which the FDA says isn’t true). Now America’s favorite diet soda, Diet Coke, is experiencing a bit of a drop-off in sales because people are worried about the safety of its artificial sweetener, aspartame.

    Steve Cahillane, president of Coca-Cola America, acknowledged that Diet Coke sales were down three percent last year because of growing concerns over artificial sweeteners. Cahillane made the surprising admission during a conference call with industry analysts on Tuesday.

    Diet Coke sales “are under a bit of pressure as people are questioning ingredients [and] ingredient safety,” said Cahillane. “There are headwinds that we’re facing,” Cahillane added. “This is just one of them.”

    Despite the drop in sales, Cahillane says that Coca-Cola isn’t changing Diet Coke’s recipe anytime soon. Diet Coke is still the number two selling soda in the world, right behind Coca-Cola. Even though safety concerns are an issue with Diet Coke (and pretty much all diet soft drinks), it’s easy to see why the Coke execs aren’t looking to change things up anytime soon.

    Are you concerned about artificial sweeteners or will you keep drinking Diet Coke or another diet beverage? Respond here.

    Is Aspartame Dangerous?

    While the American Cancer Society says that researchers haven’t found any solid proof that aspartame is linked to cancer in humans, there is some proof of an increase in blood cancer in lab animals. This alone isn’t enough to get aspartame labeled unsafe, though. The American Cancer Society also says that no other health issues have been linked conclusively to aspartame.

    The FDA also says there isn’t enough proof that aspartame is dangerous enough to ban it. The “FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food.”

    Image via YouTube

  • Sheryl Crow Admits Knowledge of Armstrong’s Doping

    In “Wheelmen: Lance Armstrong, The Tour de France and The Greatest Sports Conspiracy Ever,” a new book by Wall Street Journal reporters, Reed Albergotti and Vanessa O’Connell, set to release next Tuesday, Sheryl Crow admits that she knew what Lance was doing while he was doing it.

    Crow and Armstrong dated, and were even engaged, for a brief period of time in the mid-2000’s. In 2004, Crow flew with Armstrong to Belgium in his private jet. Once there, Crow witnessed Armstrong undergo a blood transfusion. The purpose of the transfusion was to increase the number of red blood cells in Armstrong’s body, thus increasing the amount of oxygen that could be transported to and used by Armstrong’s muscles. This procedure was a way in which Armstrong could get a leg-up on his competition without testing positive for illegal substances.

    Albergotti and O’Connell state in their book that “Rather than try to hide the transfusion from her, Armstrong was completely open about it. He trusted that Crow would have no desire to tell the press or anyone else about the team’s doping program. He explained that it was simply part of the sport – that all cyclists were doing the same thing.”

    While many other cyclists may have been doing the same exact thing, most of them were not winning multiple Tour de France titles and constantly drawing attention to themselves.

    Crow decided to talk to the FDA only after she had been offered a proffer – a legal document which prohibits one from being prosecuted due to cooperating with the investigation.

    While Crow has escaped legal prosecution, Armstrong is still in hot water. The Justice Department is still prosecuting Armstrong under the False Claims Act due to Armstrong receiving millions of dollars in sponsorship from the USPS while knowingly violating his contract.

    Armstrong opened up to Oprah Winfrey last January and admitted that his entire career was one big lie, he was not able to save face. Once mentioned in the same sentences as Michael Jordan and Tiger Woods as one of the most dominant athletes in his sport of all time, Armstrong and his “Live Strong” campaign have fallen harder than the Roman Empire. If Armstrong is convicted by the Justice Department under the False Claims Act, his career will have an asterisks as permanent as Pete Rose’s has been.

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  • FDA Approves New Antidepressant, Brintellix

    The U.S. Food and Drug Administration (FDA) today announced that it has approved vortioxetine, a new medication to treat major depressive disorder in adults. The drug is marketed by both Takeda Pharmaceuticals and Lundbeck as Brintellix, and will come in 5 mg, 10 mg, 15 mg, and 20 mg tablets.

    The drug was approved following six clinical trials which showed the medication was successful in treating depression. A seventh study also showed that, after treatment with Brintellix, patients may see a decrease the chance of becoming depressed again.

    “Major depressive disorder can be disabling and can keep a person from functioning normally,” said Dr. Mitchell Mathis, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression.”

    As a serotonin modulator, Brintellix’s side effects were found to be similar to those of other antidepressants. During the trials the most common side effects identified were nausea, constipation, and vomiting. In addition, Brintellix will carry the same box warning as other antidepressants, warning that antidepressants have been found to increase the risk of suicidal thoughts in children, teens, and young adults up to the age of 24.

  • Listeria Outbreak: Farmers Arrested for Role

    In 2011, the United States saw one of its worst food-borne sicknesses in its history: 33 people were killed and 147 more faced serious illness. Yesterday, the two men responsible for the outbreak, Eric and Ryan Jensen, were arrested and charged for a misdemeanor account of introducing adulterated food into interstate commerce.

    The charge is a rare one. The U.S. Attorney’s office usually does not press charges against farmers for food-borne illnesses, mainly due to issues of origin and culpability. However, this case is different due to the ease in which the FDA was able to track down the origins of the outbreak, and due to the large number of people affected by the sickness.

    There are six charges brought against each other the brothers, and each charge carries a year in prison and a $250,000 fine, totaling 6 years in prison and $1.5 million in fines, if the brothers are charged.

    Eric and Ryan Jensen’s lawyer issued a statement in which he expressed his clients’ innocence: “The charges against Eric and Ryan Jensen do not imply that they knew, or even should have known, that the cantaloupes had been contaminated. As they were from the first day of this tragedy, the Jensens remain shocked, saddened, and in prayerful remembrance of the victims and their families.”

    William Marler, the lawyer who represents the majority of the families affected by the outbreak, stated that intent does not matter in regards to the charges, however: “The real significance of the case against the Jensens is they are being charged with misdemeanors, which do not require intent, just the fact that they shipped contaminated food using interstate commerce.”

    A news release from the US Department of Justice outlines exactly how they believe the brothers were responsible for aiding the outbreak of listeria. Typically, fruit such as cantaloupes are supposed to be taken from the field, cleaned with an antibacterial solution, and stored properly in a cool area. The brothers had been following this process routinely until 2011, when they decided to but new equipment to help the process.

    The equipment they bought, however, was not made to handle cantaloupes. In fact, it was a conveyor cleaner meant for potatoes. Not only that, the equipment was previously used and not properly cleaned. “As this case so tragically reminds us, food processors play a critical role in ensuring that our food is safe. They bear a special responsibility to ensure that the food they produce and sell is not dangerous to the public. Where they fail to live up to that responsibility, and as these charges demonstrate, this office and the Food and Drug Administration have a responsibility to act forcefully to enforce the law,” stated John Walsh, US Attorney for the District of Colorado.

    Other potential sources of contamination of the cantaloupes include unsanitary warehouse conditions, such as standing pools of water on the floor, improper cooling techniques once the cantaloupes had been picked, and a delivery truck that transported cantaloupes to a cattle operation nearby.

    Listeriosis is a sickness caused by the listeria bacteria and primarily affects older adults, pregnant women, children, and adults with compromised immune systems. Symptoms include fever, diarrhea, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions. One of the reasons listeriosis can be so serious is that symptoms may not show themselves for quite some time if the bacteria is consumed by a healthy adult.

    Image via Wikimedia Commons

  • FDA Sounds-Off On Mobile Medical Apps

    FDA Sounds-Off On Mobile Medical Apps

    The U.S. Food and Drug Administration (FDA) this week issued guidance on mobile medical apps, a group of increasingly popular mobile applications that take the place of more traditional medical devices. The agency will “exercise enforcement discretion” in its regulation, ignoring the vast majority of medical apps that pose little risk.

    The FDA will, however, heavily regulate a small number of medical apps that it sees as being high-risk for patients. These apps, if they fail to work, could pose health risks to consumers. In particular, the FDA will provide oversight of apps that function as “an accessory to a regulated medical device” or apps that perform the functions of regulated medical devices.

    “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA. “The FDA’s tailored policy protects patients while encouraging innovation.”

    As smartphone technology progresses, the capabilities of the devices have enabled hundreds of uses for medical practice. For example, the FDA states that apps now exist to detect abnormal heartbeats, use mobile devices as ultrasound machines, track glucose levels for diabetics, and operate mobile devices as electrocardiography (ECG) machines. The FDA will regulate such apps using the same standards it applies to stand-alone medical devices. The agency stated it has already approved around 100 mobile medical apps for use in the U.S.

    “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

  • Ice Cream Cone Warehouse Raided Over Rodent Problem

    The U.S. Food and Drug Administration (FDA) this weekend announced that U.S. Marshals raided a food storage facility in Waynesboro, Virginia on September 16. The raid was conducted do to FDA inspectors finding “widespread” rodent and insect infestations at the location.

    Two companies, Gourmet Provisions and Royal Cup, used the premises to store food products. Gourmet Provisions manufacturers ice cream cones, branded as “Matt’s Supreme Cones.” Royal Cup provides coffee services and solutions, having clients such as Chick-Fil-A, Cracker Barrel, IHOP, Red Lobster, The Ritz-Carlton, and Waffle House. Products from both companies have been seized.

    “These companies have a responsibility for the safety and quality of their products,” said Melinda K. Plaisier, associate commissioner for regulatory affairs at the FDA. “When firms do not uphold this responsibility, the FDA will take actions that demonstrate its commitment to assuring consumers that foods they buy are prepared, packaged, and held under sanitary conditions.”

    The raid was conducted under warrants issued by the U.S. District Court for the Western District of Virginia. The warrants were issued after an FDA inspection found the rodent and insect infestations, as well as “unclean equipment” and “structural defects.” The agency asserts that the facility did not take “effective measures” to get rid of the infestations or clean food contact surfaces.

  • FDA, NIH Team Up For Tobacco Regulation Program

    The U.S. National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) today announced that they have partnered to fund 14 new “Tobacco Centers of Regulatory Science.” The agencies will put up $53 million for the program, which will be directed by the NIH Office of Disease Prevention.

    “While we’ve made tremendous strides in reducing the use of tobacco products in the U.S., smoking still accounts for one in five deaths each year, which is far too many,” said Dr. Francis Collins, director of the NIH. “FDA/NIH partnerships like the Tobacco Centers of Regulatory Science keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use.”

    According to the FDA, the program is meant to “aid in the development and evaluation of tobacco product regulations.” It will bring in scientists from many different fields to research tobacco regulation and addiction, while also serving as training centers for future tobacco researchers.

    “For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products, is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” said Dr. Margaret Hamburg, FDA Commissioner. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation.”

    Fourteen different proposals under the new program have already been selected by the NIH. Researchers across the U.S. have received grants from the program for research related to the Tobacco Centers of Regulatory Science’s seven interest areas. The interest areas include the diversity of tobacco products; reducing tobacco addiction; reducing the toxicity and carcinogenicity or tobacco; the adverse health consequences of tobacco, communications, the marketing of tobacco products, and the economics of the tobacco industry.