Adverse Event Reporting News back issues from December 2007:
'Inadequacies' at FDA risk lives, Science Board subcommittee says.(FDA management)
Dec 03, 2007 ... A new report by an FDA subcommittee says the agency can no longer adequately protect the nation's food and drug supply, "HealthDay News" reported Nov. 30. According to the report, FDA's "inability to keep up with scientific advances means that American lives are at risk." The ...
Guidance would allow drug makers to give doctors research on off-label use.(FDA guidance)
Dec 03, 2007 ... FDA is considering allowing industry to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for off-label purposes, "The Washington Post" reported Dec. 1. Under a draft ...
FDA staffer calls for new methods of testing diabetes drugs.(Drug Safety)
Dec 03, 2007 ... The FDA medical reviewer of GlaxoSmithKline's original application for Avandia is calling for experimental diabetes drugs to be tested against existing drugs, instead of the traditional method against a placebo, Reuters reported Nov. 27. Robert Misbin, M.D., a medical officer in ...
Avandia may increase risk of osteoporsis.(Drug Safety)
Dec 03, 2007 ... Avandia may increase bone thinning, a discovery that could help explain why diabetics can have an increased risk of fractures, the Associated Press reported Dec. 2. New research raises the possibility that long-term treatment with Avandia could lead to osteoporosis. The diabetes ...
FDA issues safety alert for pregnant patients using kidney transplant drug.(Drug Safety)(Brief article)
Dec 03, 2007 ... FDA issued a safety alert Nov. 27 for pregnant patients using the kidney transplant drug Myfortic delayed-release tablets, the agency stated in a release. FDA said it has been determined the medication is associated with increased risks of pregnancy loss and congenital ...
FDA committee urges stronger warnings on asthma drugs for children.(Warnings/Recalls)(Brief article)
Dec 03, 2007 ... FDA's Pediatric Advisory Committee's Nov. 28 urged that stronger label warnings focused on children be added to the packaging for GlaxoSmithKline's Serevent and Advair, two widely used asthma drugs, "The Washington Post" reported. After a 2005 panel investigation focused mainly ...
Panel seeks warning to prevent pediatric use of Provigil.(Warnings/Recalls)(Brief article)
Dec 03, 2007 ... An FDA panel said stronger warnings are needed to advise doctors not to use Cephalon's Provigil in children, "The Wall Street Journal" reported Nov. 29. The drug is approved to treat certain sleep disorders in adults, and its label already says Provigil is not approved for ...
Roche accepts FDA's proposal for stronger warning on Tamiflu.(Warnings/Recalls)(Brief article)
Dec 03, 2007 ... Roche accepted a recommendation by an FDA panel to put a stronger warning label on its flu treatment Tamiflu, a spokeswoman said Nov. 28 according to "The Washington Post." The drug's label already mentions reports of delirium and self-injury, primarily among children in Japan, ...
FDA issues early warning on Pfizer's anti-smoking drug.(Warnings/Recalls)
Dec 03, 2007 ... FDA has received reports of "suicidal thoughts and aggressive and erratic behavior" in people taking Chantix, the smoking-cessation drug sold by Pfizer, but it is too soon to say whether the drug is clearly linked with such problems, the agency said Nov. 21. Pfizer said that it ...
U.K., Germany suspend marketing of Prexige.(Warnings/Recalls)
Dec 03, 2007 ... Health regulators in the United Kingdom and Germany have suspended the marketing and sale of Prexige (lumiracoxib), a COX-2 inhibitor for patients with osteoarthritic pain, following a review of the drug's benefit/ risk profile. Novartis is informing regulatory agencies around ...
Smith & Nephew recalls knee implants due to high iron content.(Warnings/Recalls)(Brief article)
Dec 03, 2007 ... Smith & Nephew (S&N) is recalling a number of knee implants after some were found to have a higher than specified iron content, it said on Nov. 27, Reuters reported. The British group said about 275 of the affected products had been implanted and that the recall process was ...
Bodee recalls dietary supplement; may have harmful ingredients.(Warnings/Recalls)(Brief article)
Dec 03, 2007 ... Encore Tabs, a dietary supplement distributed by Bodee, are being recalled because they may contain potentially harmful undeclared ingredients, FDA stated in a release, Nov. 27. One lot of Encore Tabs was found to contain aminotadalafil, an analog of tadalafil, the active ...
Pfizer legal win might block some lawsuits over Celebrex.(Litigation)(Brief article)
Dec 03, 2007 ... Pfizer scored a victory Nov. 19 through a federal ruling that might wipe out some lawsuits alleging that the drug maker's painkiller Celebrex caused heart attacks and strokes, "The Wall Street Journal" reported. U.S. District Judge Charles R. Breyer of San Francisco ruled that ...
No new patients for Merck, Vertex trials.(Clinical trials/safety)(Brief article)
Dec 03, 2007 ... Merck and Vertex Pharmaceuticals said they will stop enrolling patients in two clinical trials for an experimental cancer drug pending further review of safety data, "The Wall Street Journal" reported Nov. 20. A patient enrolled in one of the studies experienced a prolonged ...
Abbott stent gets backing of FDA panel.(Medical Devices)
Dec 03, 2007 ... Abbott Laboratories' move to expand its reach got a boost as an FDA panel backed the company's drug-coated heart stent, despite concerns about the long-term risk of causing blood clots, "The Wall Street Journal" reported Nov. 30. The panel of outside medical experts ...
FDA panel backs heart-pump device.(Medical Devices)
Dec 03, 2007 ... An FDA advisory panel Nov. 30 unanimously recommended the agency approve the HeartMate II by Thoratec, on certain conditions, "The Wall Street Journal" reported. Those conditions include the recommendation that FDA require a post-market approval study. Thoratec has already said ...
Former FDA Commissioner McClellan to chair Reagan-Udall Foundation.(FDA management)(Brief article)
Dec 03, 2007 ... FDA announced Nov. 16 that former FDA Commissioner Mark B. McClellan, M.D., Ph.D., director of the Engleberg Center for Health Care Reform, Brookings Institution, will chair the newly-created Reagan-Udall Foundation. The nonprofit foundation was established by the U.S. Congress ...
China to extend 'arduous' drug industry clean-up.(International)(Brief article)
Dec 03, 2007 ... China is to extend a campaign to clean up its scandal-laden pharmaceuticals industry, the State Food and Drug Administration said Dec. 3, calling its task curb corruption and counterfeiting "arduous." The country's State Council, or cabinet, launched the campaign in August with ...
Conferences.(Calendar)
Dec 03, 2007 ... ExpertBriefings: European Clinical Trials Regulations: Tracked Changes and Comments on GCP, Dec. 18, 2-3 pm (EST). Francis Crawley, Executive Director General of the Good Clinical Practice Alliance, will guide the audience through the current regulatory frameworks for clinical trials on ...
OHRP still grappling with how to report AEs to IRBs, despite guidance.(Adverse event reporting)(Office for Human Research Protections)(Report)
Dec 17, 2007; ... BOSTON -- The reporting of adverse events and unanticipated problems varies from FDA to OHRP despite efforts at harmonization, and while there is some effort to get as much consistency as possible into the reporting process--notably a federal-wide electronic portal for adverse events ...
Lawmakers seek probe into FDA vote on Provenge.(Conflict of interest)
Dec 17, 2007 ... Three Congressmen have requested a hearing to investigate FDA's handling of Dendreon's cancer vaccine, Provenge, "The Wall Street Journal" announced Dec. 13. In May, FDA failed to approve Provenge, instead requesting more clinical data to support the effectiveness of it as a ...
USP, Quantros form alliance to enhance MEDMARX system.(AE Reporting)(Brief article)
Dec 17, 2007 ... The U.S. Pharmacopeia (USP) has formed a strategic alliance with Quantros, a health care information management technology provider, to enhance MEDMARX, USP's premier adverse drug event reporting program. The more robust database resulting from this alliance will provide USP ...
FDA committee rejects making Mevacor OTC.(Drug Safety)
Dec 17, 2007 ... An FDA advisory committee rejected Merck's latest bid for giving OTC status to Mevacor (lovastatin), which has been on the market for 20 years and was the first statin drug approved for lowering LDL cholesterol, according to wire reports. Too many of the wrong people would use ...
Committee opposes use of Avastin for breast cancer.(Drug Safety)
Dec 17, 2007 ... An FDA advisory committee voted Dec. 5 that Genentech's Avastin should not be approved as a treatment for breast cancer. By a 5-4 vote, the committee decided that Avastin's ability to delay the worsening of cancer did not outweigh the drug's toxic side effects, especially since ...
Mayo clinic study links anemia drugs to leukemia risk.(Drug Safety)
Dec 17, 2007 ... Anemia drugs from Amgen and Johnson & Johnson may raise the risk that patients with a bone marrow disease will later develop leukemia, according to an analysis of 30 years of patient records, Bloomberg News reported Dec. 11. Mayo Clinic researchers reviewed records of 311 ...
FDA finds no evidence of increased cardiac events with Nexium or Prilosec.(Drug Safety)
Dec 17, 2007 ... FDA announced that it has completed a comprehensive, scientific review of known safety data for the proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), and concluded that the reported difference in the frequency of heart attacks and other heart-related problems seen in ...
ADHD drugs may boost ER visits.(Drug Safety)(attention-deficit/hyperactivity disorder )(Brief article)
Dec 17, 2007 ... The use of stimulants by children and teenagers with attention-deficit/hyperactivity disorder (ADHD) may be to blame for an increased number of visits to the emergency room or doctor's office because of heart-related symptoms, but deaths or serious heart complications are rare, Reuters ...
FDA eases access to Accutane.(Drug Safety)(Brief article)
Dec 17, 2007 ... Women seeking an acne medicine that can cause severe birth defects may find it a little easier to fill their prescription, after FDA announced changes designed to ease access to the drug. A program called iPledge was designed to ensure that every user of Accutane or its generic ...
Two U.S. health care providers drop Avandia.(Drug Safety)(Brief article)
Dec 17, 2007 ... Two U.S. pharmacy benefit managers said Dec. 6 that they had dropped GlaxoSmithKline's diabetes drug Avandia from their national formularies due to safety concerns, Reuters reported. The moves by Prime Therapeutics and HealthTrans mark the latest example of U.S. health care ...
AHRQ study compares efficacy, risks of osteoporosis drugs.(Drug Safety)
Dec 17, 2007 ... Many medications reduce the risk of bone fractures in people with osteoporosis, but the most commonly used drugs--bisphosphonates--have not been proven more effective than alternatives, according to a new report funded by the Agency for Healthcare Research and Quality (AHRQ. The ...
FDA strengthens warnings on certain epilepsy drugs.(Warnings)
Dec 17, 2007 ... FDA strengthened warnings on certain drugs used to treat epilepsy, bipolar disorder and nerve pain, discussing the possibility of rare skin disorders and recommending that patients with Asian ancestry undergo genetic testing before using the drugs, "The Wall Street Journal" reported Dec ....
Exjade label to warn of hepatic failure.(Warnings)(Brief article)
Dec 17, 2007 ... Novartis informed health care professionals Dec. 12 of changes made to the prescribing information for Exjade Tablets for Oral Suspension. The Warnings and Adverse Reactions sections of the labeling have been revised to include information about post-marketing reports of hepatic failure, ...
FDA issues alert for DDAVP nasal spray, usage could cause seizures.(Warnings)(Brief article)
Dec 17, 2007 ... FDA has requested manufacturers update the prescribing information for desmopressin, marketed as DDAVP Nasal Spray, to include important new information about severe hyponatremia and seizures, the agency stated in a release Dec. 4. Certain patients taking desmopressin are at ...
FDA issues alert on radio frequency ablation devices due to patient deaths.(Medical Devices)(Brief article)
Dec 17, 2007 ... FDA alerted health care professionals of reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation, the agency stated Dec. 12. Patient selection, subsequent treatment, and technical use of the RF device, including ...
FDA expects to toughen coated-stent guidelines.(Medical Devices)(Brief article)
Dec 17, 2007 ... FDA expects to issue new testing requirements in the next few weeks for drug-coated heart stents, the agency's device chief, Daniel Schultz, said Dec. 14, according to "The Wall Street Journal." The revised guidelines come after some researchers have expressed fears that ...
Dental devices can cause serious burns, FDA warns.(Medical Devices)(Brief article)
Dec 17, 2007 ... FDA informed health care professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns, which required plastic surgery. Burns may ...
Conferences.(Calendar)
Dec 17, 2007 ... ExpertBriefings: European Clinical Trials Regulations: Tracked Changes and Comments on GCP, Dec. 18, 2-3 pin (EST).Francis Crawley, Executive Director General of the Good Clinical Practice Alliance will guide the audience through the current regulatory frameworks for clinical trials on ...
Contraindications and warnings August--2007.
Dec 17, 2007 ... FDA listed the following drugs and drug products as having had modifications to the Contraindications and/or Warnings/Boxed Warnings sections. For additional information or to read the full labeling of the drug products, visit: httg://www.fda.gov/medwatch/ Actos (pioglitazone ...