Recently added articles from Adverse Event Reporting News:
FDA unveils Sentinel Initiative to monitor drug safety.(Post-market surveillance)
Jun 03, 2008 ... FDA will have new authority to mine prescription drug usage by millions of participants in the Medicare drug program to look for safety problems with medicines and medical devices after they hit the market, the agency announced May 22. The Sentinel Initiative "will be a quantum ...
Woodcock sees some NDA delays over safety.(Drug safety)
Jun 03, 2008 ... A new focus on drug safety is delaying the approval of some medicines as regulators impose requirements meant to minimize side effects, Janet Woodcock, director of FDA's Center for Drugs, said in an interview with Reuters May 27. FDA gained new powers in March to require ...
FDA will boost label warnings on drug effects during pregnancy.(Drug safety)
Jun 03, 2008 ... FDA announced a plan to strengthen drug labels to give patients and health-care professionals more precise information about how drugs affect women during pregnancy and breast-feeding, "The Wall Street Journal" reported May 29. FDA said companies haven't done a good job of ...
Report links Pfizer drug Chantix to accidents, heart trouble.(Drug safety)
Jun 03, 2008 ... The Institute for Safe Medication Practices (ISMP) released a review of FDA adverse event reports that included 988 serious incidents linked to Chantix in the U.S. during last year's fourth quarter--the most for any medication in that period, "The Wall Street Journal" reported May 22. ...
After patient infections, FDA decides to review contact lens cleaners.(Drug safety)(Brief article)
Jun 03, 2008 ... Contact-lens cleaners face a safety review next month after similar products were recalled by Advanced Medical Optics and Bausch & Lomb because users suffered potentially blinding infections, Bloomberg News reported May 21. FDA will convene a panel of outside experts June 10 to ...
Hormone therapy pills may double clot risk.(Drug safety)
Jun 03, 2008 ... Menopausal women who take hormone-replacement therapy pills more than double their risk of developing a potentially fatal blood clot, French researchers said May 23, according to a report from Reuters. The review of 17 studies suggested that the risk was also significantly ...
Texas, NJ courts scrap Vioxx verdicts.(Litigation)
Jun 03, 2008 ... Appeals courts in New Jersey and Texas scrapped verdicts against Merck stemming from some of the earliest trials involving Vioxx, The Associated Press reported May 29. A Texas court reversed a $26 million verdict against the drug company stemming from the first trial. The court ...
Rep. Stupak nudges FDA toward subpoena power.(Legislation)
Jun 03, 2008 ... Now that Rep. Bart Stupak (D-MI) has helped push FDA Chief Andrew von Eschenbach, M.D., into asking for more money for inspections, the congressman wants to prod the commissioner into asking for something else new: subpoena power, "The Wall Street Journal" reported May 20. ...
FDLI publishes handbook on pharmaceutical risk management.(Risk management)(Brief article)
Jun 03, 2008 ... To help pharmaceutical companies, consultants and other drug industry stakeholders prepare and comply with the new rules on risk evaluation and mitigation strategy (REMS) mandated under the Food and Drug Administration Act Amendments of 2007, the Food and Drug Law Institute (FDLI) has ...
AHRQ announces guide to help patients avoid adverse events with warfarin therapy.(Adverse Effects)(Brief article)
Jun 03, 2008 ... The Agency for Healthcare Research and Quality (AHRQ) released a new consumer publication to explain what patients should expect and watch out for while undergoing Coumadin/warfarin therapy. In 2005, more than 3.8 million Americans were taking Coumadin/warfarin at an estimated ...
Canada biotechs criticize FDA's slow drug review.(International)
Jun 03, 2008 ... Canadian biotechnology companies have joined a chorus of their global counterparts to rail against FDA's tardiness in approving new drugs, Reuters reported May 26. Products by companies such as Labopharm and Cardiome Pharma have been delayed in the key U.S. market for months, ...
New Zealand recalls heparin-coated oxygenator.(International)
Jun 03, 2008 ... A medical device used in heart-lung bypass surgery in New Zealand was coated in contaminated heparin and has been quarantined, that country's Ministry of Health announced May 23. Contaminated supplies of the blood thinner used in dialysis and other treatments was recalled ...
FDA warns against using Mommy's Bliss Nipple Cream.(Warnings/recalls)
Jun 03, 2008 ... FDA is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises. The product, promoted to nursing mothers to help soothe and heal dry or cracked nipples, contains potentially harmful ingredients that may cause respiratory distress or vomiting and ...
FDA requests recall of Xiadafil VIP tabs.(Warnings/recalls)
Jun 03, 2008 ... FDA requested that SEI Pharmaceuticals of Miami recall all Xiadafil VIP Tabs sold in eight-tablet bottles (Lot # 6K029) or blister cards of two tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood ...
Kennedy to stay on as HELP chairman despite brain cancer.(People)(Brief article)
Jun 03, 2008 ... Sen. Edward Kennedy (D-MA), who was diagnosed with brain cancer last week, has been a key player in forming FDA policy for years as the chair of the Senate Committee on Health, Education, Labor & Pensions, but will likely stay on as chairman. Noting his role in getting Congress ...
OHRP, ORI warn researchers on human subject protection and research integrity.(Warning Letters)
Jun 03, 2008 ... The Office of Human Research Protection (OHRP) and the Office of Research Integrity (ORI) issued the following warning letters concerning bioresearch compliance and human subject protection during the months of January-May, 2008. Carondelet Health Network Tucson, AZ (OHRP) ...
Joint FDA-EMEA effort seen yielding extra safety data for drug approval.(Biomarkers/International)(European Medicines Agency )
Jun 17, 2008; Mashaw, Rebecca ... FDA and the European Medicines Agency (EMEA) will allow drug companies to submit a single application to each agency with the results of seven new tests that evaluate kidney damage during animal studies of new drugs. Announcing the details June 12, FDA said the tests measure the ...
Bush formally asks Congress for $275 million to enhance drug safety; Spector critical of funds timing.(Drug safety)
Jun 17, 2008 ... After some reluctance, the Bush administration June 9 formally asked Congress for an increase of $275 million above its current budget request to enhance food and drug safety programs, according to Reuters. The White House initially requested an FDA budget of $2.4 billion for ...
EU urges more collaboration after heparin scandal.(European Medicines Agency)(European Union)
Jun 17, 2008 ... Western drug agencies need to step up cooperation to head off a repeat of the recent scandal over tainted heparin and protect patients from counterfeits, the head of EMEA said June 6, according to Reuters. "Heparin is a classic example of how things can go wrong," Thomas ...
Epilepsy drugs draw industry defense.
Jun 17, 2008 ... Drug companies are scrambling to try to convince FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, "The Wall Street Journal" reported June 4. On June 1, at a closed meeting of epilepsy ...
