Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments.
Researchers and patient advocates have long fought with drug makers and regulators over access to such information, the Wall Street Journal reports. Continue reading
The fact that energy drinks contain excessive amounts of caffeine comes as no surprise. But what are the chances that these popular beverages present real health risks? A study published in the journal Drug and Alcohol Dependence investigated this; the authors found that energy drinks may lead to caffeine intoxication, a clinical condition that could lead to death in rare instances. Signs of caffeine intoxication include nervousness, anxiety, insomnia restlessness, tremor, rapid heartbeat, pacing and gastrointestinal distress.
Caffeine is regulated by the U.S. Food and Drug Administration (FDA), but only for food products. A regular 12-ounce soda is allowed to contain a maximum of 71 milligrams of caffeine, but only has about 35 milligrams. Energy drinks manage to circumvent rules because they are considered dietary supplements, which fall outside of the agency’s jurisdiction. Furthermore, these beverages do not have to have warning labels as required of over-the-counter products. Continue reading
The Daytrana patch, a daily treatment for attention deficit hyperactivity disorder (ADHD), may cause permanent skin color changes, the Food and Drug Administration (FDA) warns.
The FDA added a new warning to the drug label to describe this skin condition, known as chemical leukoderma. The agency says patients and caregivers should watch for areas of lighter skin, especially under the drug patch, and immediately report changes to a health care professional. Patients should not stop using the Daytrana patch without first talking to a doctor. Continue reading
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has issued updated guidance for Smith & Nephew Orthopaedics Birmingham Hip Resurfacing (BHR) system due to a higher than expected failure rate. According to a medical device alert posted on the regulators’ website on June 25th, the device should not be implanted in women or patients who need a femoral head sized 46 mm or less. The notification also states to “Only use 48mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery”.
The notification instructs customers to return all devices that have femoral head sizes 46 mm and smaller. The respective acetabular and dysplasia cups should also be returned. The alert affects patients who are symptomatic, female, or patients with head sizes 46 mm or smaller. Smith & Nephew used recent data from the National Joint Registry (NJR) for England, Wales and Northern Ireland to identify these groups of high-risk patients. The device alert also gave recommendations for affected patients, including the need for blood metal ion testing. Continue reading
In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device.
The FDA said it has received 5,093 reports of adverse events—including deaths—among women who received the Essure permanent birth control implant. In the twelve years since Essure’s approval, the agency has received reports of four deaths of women who used the device, as well as five reports of deaths of fetuses in women who became pregnant despite the implant, the Wall Street Journal reports. The device has been on the market since 2002. Continue reading
In a press release issued last Tuesday, the U.S. Food and Drug Administration (FDA) announced that partially hydrogenated oils (PHO), the main source of trans fat in processed foods, must be removed from food products over the next three years. PHOs will no longer be “generally recognized as safe” or GRAS in human food, the agency said. The FDA first made about PHOs not being GRAS in 2013; the agency has just now finalized it.
Trans fat is created when hydrogen is added to vegetable oil, changing the shape of the fat so that it becomes solid at room temperature. The food industry also uses partially hydrogenated oil because it extends the shelf life of a product. However, trans fats are shown to have a detrimental affect on health; these types of fats increases your LDL (bad cholesterol) and lower your LDL (good cholesterol). “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” said FDA’s Acting Commissioner Stephen Ostroff, M.D. Continue reading
Medtronic PLC has announced the voluntary recall of 70,000 tracheostomy tubes for children and babies following reports that some patients have had difficulty breathing while using them.
Hundreds of adverse events involving the Covidien Shiley tube have been reported to regulators since 2012, when the device was altered to give it a wider angle, the Minneapolis StarTribune reports. Continue reading
Device maker Covidien has agreed to a settlement of more than 11,000 claims involving its transvaginal mesh devices, alleged to have caused severe and painful side effects.
A court filing on Tuesday in West Virginia federal court did not disclose the settlement amount or exactly how many cases would be resolved under the confidential agreement, but as of June 1, Covidien mesh products were involved in about 11,300 filed and unfiled claims, Reuters reports. Continue reading
A new research study shows that men who use Viagra and similar drugs to treat erectile dysfunction could be at greater risk of developing skin cancer.
The study, published this week in the Journal of the American Medical Association, looked at more than 4,000 men in Sweden and found that those who were prescribed a single course of an erectile dysfunction drug were one third more likely to develop a malignant melanoma. For men who had multiple prescriptions, the risk was raised by 20 percent, the (U.K.) Telegraph reports. Continue reading
A new research study reveals that some of the most widely used sleep medications could triple the user’s risk of lung cancer.
The widely used medications—benzodiazepines and “Z-hypnotic” drugs—are carcinogenic, the (U.K.) Daily Mail reports. Taking these drugs on a regular basis is linked to a higher rate of lung cancer and to a greater risk of cancerous growths in the nose, mouth, and windpipe. Continue reading