This Simple Question Can Be Challenging for a Surgeon One of the most challenging decisions a surgeon can make when revising a patient with a Stryker Accolade TMZF stem that has failed due to metal wear disease (corrosion and fretting) is whether to leave a well-ingrown stem in place. This […]
Category: Mass Torts
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable report to be updated quarterly. The data currently spans twelve years. Advocacy Groups Find Adverse-Event Reports Helpful for Protecting Consumers Business leaders, […]
The U.S. Food and Drug Administration is concerned that women are not as knowledgeable as they should be about the risks associated with permanent Essure birth control. The agency now recommends a black-box warning for the product along with a new patient checklist. The New FDA Guidance on Essure Birth Control The […]
The fate of diabetic patients who suffered pancreatic or thyroid cancer after ingesting incretin-based therapy drugs is now in the hands of the Ninth Circuit Court of Appeals after the claims were dismissed by the California federal court judge who oversaw the national coordinated litigation. In September of 2016, the […]
Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly nightshade, which it received due to its poisonous nature. Still, the plant has been used medicinally for five centuries. Food & […]
Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration (FDA) has the responsibility to govern the process by which pharmaceutical companies introduce new products and seek approval. Two methods generally […]
The National Park Service is celebrating its centennial – an historic occasion that will culminate Aug. 25. On that date in 1916, President Woodrow Wilson signed into law an act creating a new bureau within the Department of the Interior that would bear responsibility for protecting the then-35 parks in […]
Is Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]
The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less. Consumer clarity on how certain products make […]
A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency. Researchers compared adverse drug-reaction data for anticonvulsants […]
