FDA announces five-year improvement plan
WASHINGTON The Food and Drug Administration announced a five-year drug safety plan, to hire more people in order to strengthen its post-market drug-safety activities.
According to published reports, with the new plan, known as the “Prescription Drug User Fee Act IV Drug Safety Five-Year Plan,” the agency plans to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors, with its new $29.29 million allowance, which includes a yearly inflation factor as well.
The FDA also plans on increasing its technological capabilities, and focus on improving the drug safety system, which it addressed in its draft; in order to strengthen this aspect of the agency, it would need at least two-to-three years to prepare its new staff to become experts. According to published reports, under the PDUFA IV, the FDA will be able to accept user fees which would be used for REMS, post-market studies, safety labeling changes and active post-market risk identification, according to published reports.
Study shows no increased heart risk for newborns with mothers on Paxil
TORONTO According to a new study published in the American Journal of Psychiatry, infants whose mothers took the GlaxoSmithKline antidepressant drug Paxil during early pregnancy do not have an increased risk of heart defects.
The study was performed by the Motherisk program at the Hospital for Sick Children and University of Toronto. Almost 1,200 infants were studied and the results showed that infants who had been exposed to the medication had the same risk for the defects as infants not exposed, 0.7 percent.
GSK had originally published a report stating that risk of cardiovascular defects was 2 percent. Adrienne Einarson, the lead author of the new report called GSK’s initial report, “preliminary information.” GSK later adjusted its figure to 1.5 percent.
In general, the incidence of heart defects in the general population is about 1 percent.
Personal injury lawsuit filed against makers of contaminated drug Heparin
CAMDEN, N.J. A personal lawsuit against Baxter Healthcare has been filed following a near fatal reaction to the contaminated prescription drug Heparin, according to published reports.
Accounts of deaths and hundreds of severe allergic reactions stemmed from an active ingredient in the drug, which was identified as a chemically altered form of chondroitin sulfate. According to published reports, the chemical serves as a dietary supplement made from animal cartilage that is used to treat joint pain.
The contamination was rooted in China, where the drug is manufactured. The Federal Drug Administration filed a report on March 19 alerting the public of the dangers of taking the Heparin, and the medications were almost immediately recalled as a result.
“Prescription drug manufacturers have a duty to produce products that are safe and free of dangerous ingredients,” stated Wendy Fleishman of the New York City office of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein. “Only through a lawsuit or otherwise making a claim against Baxter can patients obtain compensation for their injuries. The American public needs the drug companies, like Baxter, to take responsibility for the safety of their products—especially those like Heparin, which are manufactured in part in China.”
The suit claims that Baxter did not adequately inspect the product before selling it, making them negligent, and as a result contributing to many unnecessary deaths.