Latest Fda Approved Drugs Information Systems

Posts

Consumer Reports Rates Best Sunscreen Buys

May 25, 2012 — With any luck, the Memorial Day weekend will bring weather good enough to be slathering on the sunscreen at least every two hours when outdoors. And to know which are the best products to put on your skin during the unofficial start of summer, the May issue of Consumer Reports rated 18 top-selling sunscreens. The products ranged from SPF 30 to SPF 75+ and were lotions, sprays, or a spray foam. They varied in price from a low of $.59 an ounce to a high of $20.59 per ounce. To judge the performance of each product, sunscreens were tested on people, and the ultraviolet B (UVB) radiation protection was rated before and after swimming in fresh water for up to 80 minutes. Testers also checked whether the product stained clothing. In addition, they did a new "critical wavelength" test required by the FDA to see if the sunscreen truly offered broad-spectrum UVA and UVB protection. UVB radiation is the main cause of sunburn, while UVA rays penetrate deeper, wh

Missing Data Lead FDA Panel to Vote Against Rivaroxaban for ACS May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting, the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel, or ticlopidine. Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the risk of bleeding and intracranial hemorrhage, but the studies were hindered by early patient withdrawals and missing data. We Don't Know What We're Missing Based on the ATLAS ACS 2 results, FDA reviewer Dr Karen Hicks recommended approval of rivaroxaban for the requested indications except all-cause mortality. However, another FDA reviewer, Dr Thomas Marciniak, was adamant that the trial results are not interpretable because about 12% of the patients had incomplete follow-up, far higher than the 1% to 1.5% differences in the end-point rates between rivaroxaban and placebo. A total of 1294 subjects discontinued the trial prematurely, and the company was only able to contact 183, of which 177 were confirmed to be alive. Because of the patient dropouts, the company adopted a "modified intention-to-treat analysis," whereby patients were observed for 30 days after randomization or the global end date for the trial, instead of observing all the patients until the end of the trial as the FDA originally suggested. Marciniak criticized the sponsor's efforts to follow the patients and said that three patient deaths not counted in the modified intention-to-treat analysis may just be the "tip of the iceberg." Because the percentage of patients whose ultimate vital status remains unknown is much greater than the reported differences in mortality rates, the claimed mortality benefits are not reliable. The majority of the panel sided with Marciniak. For example, Dr Sanjay Kaul (University of California, Los Angeles) voted "no" because "there was enough uncertainty in the quality and robustness of the data that dissuaded me from voting yes. . . . The 'missingness' of the data doesn't invalidate it, but it certainly makes it hard to infer [the conclusion]." Dr Steven Nissen (Cleveland Clinic, OH) said that the decision to use the modified intention-to-treat analysis had a "profound impact" on the interpretability of the data. "It's saying we don't care what happens after 30 days, [and] that colored the trial in ways we couldn't recover from." Given the risk of major bleeding, "I want to see better evidence that this strategy of adding an Xa inhibitor or a direct thrombin inhibitor or something else to a good antiplatelet agent is robustly better for the patient," Nissen said. He recommends that the companies run a new trial of the 2.5 twice-daily dose of rivaroxaban using a strict intention-to-treat approach, but, he said, "I don't expect the death benefit to be too robust." Several panelists said they were concerned that the patients who dropped out of the trial were disproportionately likely to have a bleeding event, which led them to quit the trial, or a "protopathic" event, as statistician Dr Scott Emerson (University of Washington, Seattle) put it. "We're worried that an impending event is what is changing their behavior. We see that all the time in clinical trials--that regularly measured end points do not pick up [all of] the events," he said. He said that since the company was only able to contact 183 of the over 1200 patients who dropped out, it is possible that the dropouts skew the outcomes comparison of the trial. "Differential event rates after dropout are the number-one thing we're afraid of, so you have to explore it" in a statistical sensitivity analysis of the potential impact of these unknown outcomes. "It would not surprise me if, at the end of the day, these data did not hold up under a proper sensitivity analysis," he said. "What I want to know is, among the people who had events, how differential was the follow-up, but I can tell you by just looking at it, there was a very slightly different amount of follow-up of the people in the treatment arm. But I don't know whether everyone in the treatment arm was cured and they were trekking in the Himalayas and everyone in the placebo arm went home to die. I don't know that that's not the case." Dr Maury Krantz (University of Colorado, Denver) voted in favor of approval but said he does not know how rivaroxaban would perform in general clinical practice, especially when used with aspirin and clopidogrel. "I felt very much torn by this. This isn't a simple paradigm shift. It means going to triple therapy, which is really a three-headed monster in many ways. I think that what you're going to see in practice, if this is not done carefully with the proper labeling and secondary studies, is really dramatic magnification of bleeding and perhaps minimization of the efficacy benefit."

May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting , the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel , or ticlopidine . Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the risk of bleeding and intracranial hemorrhage, but the studies were

FDA Advises Checking Prefilled Syringes for Overfilling

May 23, 2012 — The US Food and Drug Administration (FDA) today issued an advisory warning healthcare providers to visually inspect Hospira Carpuject prefilled cartridges for overfill. About 46 million units are included in the 280 lots involved in the warning, according to company spokesperson Tareta Adams. However, Adams noted that clinicians should, as part of using any prefilled syringe, visually inspect it before using. In addition, she told Medscape Medical News that much of the supply in question that is currently circulating has been used up. In addition, according to the FDA, the firm's investigation found that the number of overfilled Carpuject prefilled cartridges appears to be low. The FDA advisory covers 15 types of medications supplied in the form of a Carpuject prefilled syringe. Products include meperidine, diazepam, fentanyl, heparin, hydromorphone, ketorolac, labetalol, lorazepam, metoprolol, midazolam, morphine, naloxone, ondansetron, and sodium chlorid

FDA Approves Sixth Pancrealipase Product for Cystic Fibrosis

May 23, 2012 — The US Food and Drug Administration (FDA) has approved pancrealipase delayed-release capsules ( Pertzye , Digestive Care Inc) for the treatment of children and adults with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF) or other conditions. The unique pancreatic enzyme product contains bicarbonate-buffered enteric-coated microspheres and is protected by several US and international patents. It has been marketed by the company under the trade name Pancrecarb MS-16 since 2004. Representing the sixth such product for patients with CF, Pertzye comes on the heels of 2 other newly FDA-approved similar products ( Ultresa , Aptalis Pharma US Inc; and Viokace , Confab Laboratories Inc), as reported by Medscape Medical News . Other previously FDA-approved pancrealipase pharmaceuticals include Creon (Abbot Labs), Zenpep (Eurand SPA), and Pancreaze (Ortho-McNeil-Janssen Pharmaceuticals Inc). Small Study Leads to Big Results FDA approval

FDA Panel Gives Qualified Nod to Drug for FAP

May 25, 2012 — In a 13 to 4 vote, the Food and Drug Administration's (FDA's) Peripheral and Central Nervous System Drugs Advisory Committee decided that findings of a single study assessing the drug tafamidis in patients with familial amyloid polyneuropathy (FAP) don't meet criteria for efficacy on a clinical endpoint. However, the committee did decide — in a complete vote reversal — that the study had substantial evidence of effectiveness for a biomarker or surrogate marker endpoint, in this case, tests of muscle strength and small fiber function. FAP is a rare genetic disorder causing build-up of abnormal amyloid proteins. The FDA will now consider the committee's recommendation when making its decision on the New Drug Application (NDA) for tafamidis meglumine capsules (proposed trade name, Vyndaqel ) submitted by FoldRx Pharmaceuticals Inc, a subsidiary of Pfizer Inc. In advance of the meeting, the FDA's own drug reviewers had recommended rejecting the

Medication 'Take-Back' Programs Ill Conceived, Study Says

May 18, 2012 — Prescription medication "take-back" programs are increasingly promoted as a way to safely dispose of unused drugs, but they are no better for the environment than simply throwing old drugs in the trash, a new study suggests. When researchers used a complicated methodology called "comparative life cycle assessment" to estimate the environmental impact of flushing, incinerating, and trashing old medications, they found little difference between burning the drugs -- which is what most take-back programs do -- and having them end up in the landfill. Close to 200 million pounds of drugs go unused in the U.S. each year. There are serious concerns that antibiotic and hormone medications pose a threat to the nation's lakes, rivers, and other water supplies. While most of these concerns involve flushed waste that contains residues of used medications, unused drugs may also be finding their way into the nation's water supply, researcher Steve

Phentermine Returns for Weight Loss, But at a Low Dose

May 25, 2012 (Lyon, France) — The combination of low-dose phentermine plus extended-release topiramate ( Qnexa , Vivus) might help overweight and obese people lose weight, regardless of their obesity-related risk or the extent of their comorbidities. Stephan Rössner, MD, PhD, professor emeritus of health-related behavioral science at the Karolinska Institute in Stockholm, Sweden, presented results from the CONQUER trial here at the 19th European Congress on Obesity. Subjects receiving the combination had significantly greater weight loss, regardless of their baseline Edmonton Obesity Staging System (EOSS) stage, than subjects just modifying their lifestyle. Although body mass index (BMI) denotes the presence and degree of excess weight, it does not give any information about weight-related comorbidities. The EOSS is a classification system that considers the presence and magnitude of weight-related comorbidities and functional status. Stage 0 indicates no apparent risk factors,