Lawsuits Accuse Stryker of Hiding Problems with Spine Implant
Fourteen lawsuits against device maker Stryker allege that Stryker’s CerviCore artificial discs are so dangerous that the company abandoned a clinical trial of the device and abandoned plans to obtain premarket approval (PMA) for the product. After the fourteenth suit was filed, Judge James D. Bates of Lucas County, Ohio ordered … [Read more...] about Lawsuits Accuse Stryker of Hiding Problems with Spine Implant
Questions about Sexual Side Effects of Hair-Loss Drug
A review of 34 clinical trials on a popular drug to treat hair loss in men found that none of the studies adequately reported on the drug’s sexual side effects. The findings raise serious questions about whether finasteride, marketed as Propecia and Proscar, among other names, is safe, according to the report by scientists at … [Read more...] about Questions about Sexual Side Effects of Hair-Loss Drug
FDA is Aware of Fraudulent Clinical Trials Hidden from Public
FDA Is Aware Of Fraudulent Clinical Trials. The U.S. Food and Drug Administration (FDA) is aware of faulty clinical trials, but a recent investigative report shows that this information was never made public. Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University uncovered … [Read more...] about FDA is Aware of Fraudulent Clinical Trials Hidden from Public
Samsca Liver Injury Risk
Samsca May Cause Liver Injury. Clinical trials have revealed drug-induced liver injury in patients taking Samsca (tolvaptan). Samsca was being tested for an unapproved use in patients diagnosed with autosomal dominant polycystic kidney disease (ADPKD) at higher doses than the approved indication and in long-term use. The … [Read more...] about Samsca Liver Injury Risk
Medtronic Infuse Clinical Trials Under Fire
Medtronic Infuse Adverse Events. The Side Effect Associated With Medtronic Infuse Bone Graft Product Serious questions were raised about side effects associated with Medtronic Inc.'s Infuse bone graft product by a study published in The Spine Journal last summer. The study found that published reports for 13 Medtronic-fund … [Read more...] about Medtronic Infuse Clinical Trials Under Fire
Increased Scrutiny for Overseas Drug Company Clinical Trials
Overseas Drug Company Clinical Trials. Overseas health regulators are beginning to take a closer look at drug clinical trials conducted in their countries, following several well-publicized safety scandals, The Wall Street Journal reports. The crackdowns have cheered many patient advocates, who say the growing reliance on overseas … [Read more...] about Increased Scrutiny for Overseas Drug Company Clinical Trials
Quality Assurance Programs Improve Clinical Trials in Cancer
Quality Assurance Programs to Strengthen Clinical Trials A study just presented on September 21 at the 50th annual meeting of the American Society for Therapeutic Radiology and Oncology confirms that quality assurance programs help to strengthen the quality of clinical trials. The study mentioned quality assurance programs … [Read more...] about Quality Assurance Programs Improve Clinical Trials in Cancer
FDA Now Listing Some Drugs Being Investigated
FDA Now Listing Some Drugs. Effective immediately, the U.S. Food and Drug Administration (FDA) will begin posting a quarterly list of drugs whose safety is under investigation over complaints brought to its attention by drug companies, physicians, and patients. Although the FDA investigates drugs because of data from … [Read more...] about FDA Now Listing Some Drugs Being Investigated
Improved Monitoring Needed for Drug Trials Involving Children
Drug Trials Involving Kids Drug clinical trials involving children don't get enough scrutiny, a new study says. According to experts at Great Britain’s University of Nottingham, the method and processes in which drug trials are conducted in children require more and stricter monitoring and more needs to be done to ensure the … [Read more...] about Improved Monitoring Needed for Drug Trials Involving Children
FDA Panel Calls for Further Study of Over-the-Counter Children’s Cold Medicines
Children’s Cold Medicines Need More Study. There is no evidence that over-the-counter cold remedies work for small children, and manufacturers of these products should subject them to clinical trials in order to prove their safety and effectiveness. That was the conclusion of a Food & Drug Administration advisory panel … [Read more...] about FDA Panel Calls for Further Study of Over-the-Counter Children’s Cold Medicines
Tamoxifen Stroke Risk
Breast-Cancer Drug May Cause Stroke. The breast cancer drug tamoxifen appears to increase a woman's risk of having a stroke, although the overall risk is small, according to a systematic review of nearly 25 years worth of clinical trials of the drug. Doctors say the finding should not stop breast cancer patients from … [Read more...] about Tamoxifen Stroke Risk
