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efficacy 39 articles

Long-term safety, efficacy data needed for ADHD drug use in children

Children who are prescribed medication to treat symptoms of attention-deficit hyperactivity disorder, or ADHD, take the drugs for several years. However, there have been no studies to show how effective or safe the medication is for the long-term, or how to detect rare side effects, according to a report in the journal PLOS ONE. According to the Centers for Disease Control and Prevention (CDC), 11 percent of children in the United States between the ages of 4 and 17 – or about 6.4 million – are diagnosed with ADHD. The Food and Drug Administration (FDA) has approved 20 drugs to ... Read More

Implantable birth control microchip to enter pre-clinical trials next year

A new implantable birth control device containing the hormone levonorgestral that lasts 16 years and can be turned off and on with a wireless remote is currently in development and will enter pre-clinical testing next year. The chip is designed to be implanted under the skin at the buttocks, upper arm, or abdomen, and if tests prove it to be safe and effective, the device could be on the market as early as 2018. The concept of a birth control chip originated two years ago when Bill Gates and his colleagues visited Massachusetts Institute of Technology (MIT) and asked technicians ... Read More

New Jersey business groups urge court to toss Ethicon whistleblower case again

The New Jersey Supreme Court’s Appellate Division last year decided to revive a whistleblower lawsuit against Johnson & Johnson’s Ethicon unit, triggering a backlash from state business groups who argue that the case effectively would allow employees in watchdog positions to file improper whistleblower lawsuits. Law360 reports that the New Jersey Business & Industry Association and the New Jersey Civil Justice Institute filed a brief June 2 urging the high court to overturn the Appellate court’s decision. They are the latest tort-reform minded groups to push back against the decision, saying that it improperly broadens the state’s whistleblower law by ... Read More

Lawsuit alleges Forest mislead public about Celexa, Lexapro effectiveness in treating childhood depression

Forest Laboratories is facing a potential class action lawsuit in Massachusetts federal court by two funds that allege the company illegally marketed its antidepressants Celexa and Lexapro and paid kickbacks to others to endorse the drugs as a treatment for pediatric depression. The lawsuit, filed by Allied Services Division Welfare Fund and New Mexico UFCW Union’s and Employers’ Health and Welfare Trust Fund, allege they and others had to pay or provide reimbursement for Celexa and Lexapro. However, the lawsuit claims, the sales of those drugs were based on inadequate drug labels that were designed to mislead consumers and the ... Read More

FDA wants to overhaul process for reviewing nonprescription medicines and products

The Food and Drug Administration (FDA) wants to overhaul its process for regulating over-the-counter medicines, saying the decades-old system is flawed and grossly outdated. A two-day meeting among drug regulators is planned next month to discuss a modern-day alternative. The current monograph was established in 1972 as a way to set dosing, labeling and other standards for nonprescription drug ingredients, from aspirin to anti-bacterial soaps. But the process is slow and laborious, requiring scientific reviews, public hearings and comments before a final monograph is published, resulting in a review backlog of many common pain relievers. It also stalls the addition ... Read More

FDA panel gives thumbs-down to new anti-platelet drug cangrelor

The new intravenous blood thinner cangrelor should not be approved for marketing because data from two separate clinical trials demonstrating the drug’s safety and efficacy were unconvincing and flawed, a Food and Drug Administration (FDA) advisory panel found. Cangrelor was being considered for two separate indications – to prevent blood clots associated with coronary stenting and in patients whose existing antiplatelet therapy is interrupted for surgery. Cangrelor is a member of the P2Y12 inhibitor class of antiplatelet agents, which also includes clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta). Committee member Stuart Rich, M.D., of the University of Chicago, expressed concerns ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More

Takeda gives up on diabetes drug candidate due to liver damage risk

Takeda Pharmaceuticals, Asia’s largest drug maker, has halted development of its new diabetes treatment, known as TAK-875 or fasiglifam, because the drug was linked to liver damage. Takeda tried to find a silver lining in the cloud of data, hoping that the drug’s efficacy profile would outweigh the liver risks. However, after consulting with three independent panels on clinical trials results, the writing was on the wall. “The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said. “Takeda is working with trial investigators and local regulatory ... Read More

FDA panel questions whether bowel disease drug increases risk of deadly brain infection

A Food and Drug Administration (FDA) advisory panel is questioning the safety of Takeda Pharmaceutical’s inflammatory bowel disease drug candidate vedolizumab, claiming the drug could cause patients to develop a rare but deadly brain infection. The panel is set to rule on Dec. 9 whether to recommend the drug be approved for marketing in the United States. The medication fared well in clinical trials as a treatment for ulcerative colitis and Crohn’s disease, but experts say the drug carries the risk of progressive multifocal leukoencephalopathy (PML), a life threatening brain disease that affects immune deficient patients. No patients in clinical ... Read More

Court says former Johnson & Johnson executive’s whistleblower complaint can go to trial

A former Ethicon executive who claims he was fired in retaliation for voicing concerns about product safety and efficacy has had his case upheld and remanded for jury trial by a judicial panel in New Jersey Superior Court. Joel Lippman, former vice president of clinical trials for Johnson & Johnson‘s unit Ethicon, claims he was fired in May 2006 for raising concerns about the safety and effectiveness of several medical products, which resulted in delayed product launches, recalls, and other setbacks for the medical products conglomerate. Mr. Lippman alleges Ethicon retaliated against him even though calling out safety and efficacy ... Read More