Drug Safety Issues
A sensational investigative report by by Harriet Ryan, Lisa Girion and Scott Glover in the Los Angeles Times (May 5, 2016) exposes the irresponsible, corrupt practices of Purdue Pharmaceuticals, the company that manufactures and aggressively markets OxyContin at a dosing schedule that some doctors have described as “an addiction producing machine.”…
List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.
Public Citzen petitioned FDA Commissioner to immediately removal from market Pfizer’s Alzheimer’s drug, Aricept 23 mg dose, because of serious safety hazards and failure to demonstrate efficacy. The petition also urges FDA to add a label warning on Aricept and generic donepezil (5 mg and 10 mg) stating: "Use of 20 mg per day is counter indicated."
*More antipsychotic treatment was associated with smaller gray matter volumes. Progressive decrement in white matter volume was most evident among patients who received more antipsychotic treatment.
Overall in the 2nd quarter of 2010, the FDA received 33,068 domestic reports of serious injury, disability or death associated with drug therapy–an increase of 12% from the same quarter one year ago.
"Prescription Drugs Associated with Reports of Violence Towards Others, " identifies 31 drugs linked to 1,527 acts of violence…
The FDA announced that the postmarketing trial of Avandia, known as TIDE, has been placed on "partial clinical hold." No new patients may be enrolled in the trial.
Evidence that GlaxoSmithKline concealed adverse events in their trial testing their diabetes drug, Avandia, raises the question “whether the entire system is corrupt.” “To the extent that we can’t trust the data. We are in jeopardy of giving patients the wrong drugs.” Dr. Jerome Kassirer
One has to wonder why discovery of defective cars are front page news while defective FDA-approved prescription drugs are accepted as part of life’s risk.
The latest QuarterWatch report (May 7, 2009) by the Institute for Safe Medication Practices (ISMP) found the following disturbing trends during the third Quarter of 2008:
The State of Florida has established a pre-approval requirement to protect preschool children on Medicaid from being exposed to the hazardous effects of antipsychotic drugs. That step has prompted "a seismic change" in doctors’ inappropriate prescribing of antipsychotics for preschool children: the number of prescriptions for this age group has…
Dr. Margaret "Peggy" Hamburg, a former health commissioner in New York City, is the leading candidate to become FDA commissioner, the agency's top job, while Baltimore health chief Joshua Sharfstein is in line to become a deputy commissioner
