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 […]
Category: Defective Drugs
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 […]
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses. In the federal case of Amarin Pharma Inc. […]
The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims. Pfizer, the manufacturer of Viagra, did not oppose this request by the Plaintiffs. Pfizer’s attorneys also agreed with the Plaintiffs’ suggestion that all of the pending Viagra […]
Serious Side Effects Associated with Popular Antibiotic Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated with the pills sold commercially as Avelox, Cipro and […]
The American Society for Bone and Mineral Research recently reassessed the efficacy of bisphosphonate, long hailed as a wonder drug for patients with osteoporosis, and its risk factors. Through the course of two clinical trials by the society’s Professional Practice Committee, it was determined that bisphosphonate therapy should be evaluated […]
The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers. Sen. Ed Markey, D-Mass., has led the delay in appointing Robert Califf to the position of commissioner until the […]
In February 2015, sixteen plaintiffs sued Pfizer, the maker of Viagra, alleging that their ingestion of Viagra between 1998 and 2013 caused them to develop melanoma. Plaintiffs asserted the following cause of actions: breach of implied warranties, breach of express warranties, fraudulent concealment, gross negligence, loss of consortium, negligence, reckless […]
Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits outweigh its risks? Questions such as those and a flurry of others have made […]
