Adverse Event Reporting News back issues from July 2007:
House votes to increase drug safety spending.(Legislation)
Jul 16, 2007 ... The House voted 403-16 July 11 to give FDA more money and power to police the safety of prescription drugs, "The Washington Post" reported. The bill gives FDA nearly $400 million, collected from user fees, which can be spent on drug safety over the next five years. The Senate ...
Lilly may face more Zyprexa lawsuits after FDA letter.(Litigation)
Jul 16, 2007 ... Lilly may attract more lawsuits alleging it failed to warn users that its psychiatric drug, Zyprexa, was linked to diabetes after the 'firm received a letter from FDA. FDA told Lilly in March it would delay the approval of Symbyax for hard-to-treat depression because the agency ...
Avandia adverse effect reports triple.(Drug safety)
Jul 16, 2007 ... In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled, The Associated Press (AP) reported July 13. The sudden spike is a sign that doctors probably were unaware of ...
Establishing policy and procedures for explorations into third-party data.(Pharmacovigilance Update)
Jul 16, 2007; ... Safety organizations must rely on numerous types of data sources to support their safety surveillance and pharmacovigilance efforts. Important safety questions require identification and selection of quality data sources with attributes that best address potential hypothesis and required ...
Electronic health records don't improve care.(Electronic records)
Jul 16, 2007 ... Electronic health records--touted by policymakers as a way to improve the quality of health care--failed to boost care delivered in routine doctor visits, U.S. researchers said July 9. Of 17 measures of quality assessed, electronic health records made no difference in 14 ...
Consumers continue to buy potentially risky drugs over the Internet, FDA says.(Drug Safety)
Jul 16, 2007 ... FDA continues to warn U.S. citizens about the dangers of buying medications over the Internet and is now noting that generic drugs exist for many of the medications Americans are trying to buy in Canada. New data collected by FDA show that consumers who are trying to save money ...
Antidepressant warnings associated with decreased prescription rates among Tennessee children.(Drug Safety)
Jul 16, 2007 ... Regulatory warnings regarding the risk of suicidal thoughts and behaviors appear to be associated with reductions in the number of antidepressant medication prescriptions among children and adolescents covered by Tennessee's expanded Medicaid program, according to a report in the July ...
Antidepressants linked to bone loss.(Drug Safety)(Report)
Jul 16, 2007 ... Older men and women who take selective serotonin reuptake inhibitors (SSRIs) for depression may have an increased rate of bone loss, according to a report by "HealthDay News." But the studies documenting this finding are preliminary and shouldn't be seen as a reason to change ...
Some diabetes drugs provide advantages in weight, cholesterol control.(Drug Safety)(Report)
Jul 16, 2007 ... Most oral medications prescribed for Type 2 diabetes are similarly effective for reducing blood glucose, but the drug metformin is less likely to cause weight gain and may be more likely than other treatments to decrease so-called bad cholesterol, according to a report funded by AHRQ. A ...
Former Chinese health official executed, second official sentenced.(International)
Jul 16, 2007 ... A former top Chinese government health official was executed after being found guilty of taking $850,000 in bribes and dereliction of duty, China's official Xinhua News Agency reported July 9. Zheng Xiaoyu was director of China's State Food and Drug Administration from June 1997 ...
China suspends sale of leukemia drug.(International)
Jul 16, 2007 ... In the aftermath of a series of scandals involving corruption in its drug industry and regulatory agency, China's State Food and Drug Administration announced it is suspending the sale of a drug used to treat acute leukemia and rheumatoid arthritis. The agency announced July 7 ...
Zambia bans use of AIDS drug, may seek compensation.(International)
Jul 16, 2007 ... Zambia has banned the use of an imported HIV/AIDS drug that was recently recalled in Europe due to contamination and might seek compensation from the company that manufactures it, a senior Zambian official said July 10, according to Reuters. Viracept, an HIV medication commonly ...
Nigerian court postpones Pfizer case.(International)(Brief article)
Jul 16, 2007 ... A Nigerian court has adjourned until October a criminal case between Pfizer and northern Kano state, which is seeking $2 billion over allegations that a 1990s Pfizer drug study led to deaths and disabilities in children, the AP reported July 10. Presiding judge Shehu Atiku said ...
Antibiotics don't prevent future urinary tract infections in children.(Antibiotic resistance)(Report)
Jul 16, 2007 ... After a first childhood urinary tract infection (UTI), daily antibiotics may not prevent another such infection, and may actually increase the risk that the next urinary tract infection is caused by resistant bacteria, according to a new study in the July 11 issue of the "Journal of the ...
Bone loss drugs may kill bacteria, research shows.(Antibiotic resistance)(Report)
Jul 16, 2007 ... Two drugs used to treat bone loss in old age may provide a new weapon against antibiotic-resistant bacteria blamed for nearly 100,000 hospital deaths across the country each year, researchers at University of North Carolina-Chapel Hill (UNC) discovered. The drugs both kill and ...
FDA adds black box to Xolair.(Warnings/Recalls)(Brief article)
Jul 16, 2007 ... FDA finalized a strong new label warning patients and doctors about a potentially deadly allergic reaction from Genentech's asthma drug Xolair. The agency had proposed the so-called black box warning about anaphylaxis in February, but announced final wording of the label on ...
FDA warns Roche antibiotic plus calcium may endanger babies.(Warnings/Recalls)(Brief article)
Jul 16, 2007 ... FDA warned July 5 that babies are at increased risk of death if they are given Roche's Rocephin along with products containing calcium. Roche sent doctors a letter on the danger of administering calcium within 48 hours of using Rocephin, an injectable antibiotic, after reports ...
Merck recalls some vials of Invanz following reports of broken glass.(Warnings/Recalls)(Brief article)
Jul 16, 2007 ... Merck recalled three lots of the injectable antibiotic Invanz after broken glass was found in the solution on two occasions, FDA stated in a release July 5. Doctors shouldn't administer any shots from the 75,000 recalled vials, FDA said in a notice. Invanz is mixed into an ...
Use of sirolimus-eluting stents in diseased vein grafts may increase mortality.(Medical devices)(Report)
Jul 16, 2007 ... Although use of sirolimus-eluting stents (SES) in diseased saphenous vein grafts may lower the short-term risk of repeat revascularization compared with use of bare metal stents (BMS), it may increase long-term mortality, according to a Reuters Health report. In an earlier ...
Opening kidney arteries brings dangers.(Medical devices)
Jul 16, 2007 ... Angioplasty and stenting can open blocked kidney arteries, but the procedure also throws off an immense amount of debris that can hurt kidney function, a new study shows, according to a report in "HealthDay News" June 29. It has been known that this procedure, done primarily to ...
Long-term selenium supplementation may raise risk of Type 2 diabetes.(Supplements)
Jul 16, 2007 ... In the largest and longest clinical trial to date comparing the effects of selenium supplements versus placebo, daily oral doses of the mineral failed to reduce the incidence of Type 2 diabetes and may have increased it, Reuters Health reported. Because of its anti-oxidant ...
Computerized ordering cuts medication errors.(Medication errors)(Brief article)
Jul 16, 2007 ... U.S. hospitals that switched from using doctors' handwritten prescriptions to computerized drug ordering systems had a 66% drop in medication errors, say the authors of a review that looked at the results of 12 studies, according to a report from "HealthDay News." The findings ...
Easing your pain when dealing with IT and Part 11 compliance - July 25, 2-3pm.(Upcoming Audioconference ...)
Jul 16, 2007 ... Frustrated with your computer department and their "help" with compliance? Would you like IT personnel that actually "get" compliance? Worried about the inspector's expectations around computer validation today? This presentation offers proven tactics to help you identify where the ...
EMEA satisfied with achievements, progress in risk management.(International)(European Agency for the Evaluation of Medicinal Products)
Jul 30, 2007; ... Reviewing the status of implementation of the European Risk Management Strategy (ERMS) during their meeting in Lisbon on July 10, the European Medicines Agency (EMEA) and Heads of Medicines Agencies (HMA) expressed their satisfaction with the progress made to date and had a first ...
Senators say FDA pulled scientist off Avandia review.(International)(Food and Drug Administration)(Brief article)
Jul 30, 2007 ... An unidentified senior FDA scientist has told congressional investigators that the agency removed him or her from work on Avandia after voicing concerns about the safety of the diabetes pill, two senators said July 24. The unnamed FDA medical officer at one time was the primary ...
FDA to convene panel to discuss anemia drug.(Drug Safety)(Food and Drug Administration)(Aranesp, Epogen and Procrit)
Jul 30, 2007 ... Safety questions surrounding anti-anemia drugs by Amgen and Johnson & Johnson (J&J) will be addressed by an FDA panel in September, "The Wall Street Journal" reported. In a Federal Register notice published July 20, FDA said that it would convene a joint meeting of its ...
Patient death leads FDA to suspend gene therapy study.(Drug Safety)(Food and Drug Administration)
Jul 30, 2007 ... FDA has suspended a Seattle company's gene therapy study after learning that a patient died, The Associated Press (AP) reported July 26. Targeted Genetics, which notified FDA of the patient's illness and subsequent death, had enrolled more than 100 people in a study of gene ...
Restricted use of Zelnorm allowed for qualifying patients.(Drug Safety)
Jul 30, 2007 ... FDA announced July 27 that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment IND protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines. ...
Vioxx's risks may begin earlier than thought.(Drug Safety)
Jul 30, 2007 ... The increased heart risk from Vioxx, Merck's withdrawn arthritis medicine, begins much earlier than after 18 months of use, according to a study that contradicts assertions by the drug maker and its scientists. Reuters reported. The 2,434-patient study, published July 25 in the ...
Panel recommends FDA approve osteoporosis drug to cut breast cancer risk.(Drug Safety)(Food ans Drug Administration)
Jul 30, 2007 ... Despite concerns over cardiovascular side effects, an FDA advisory committee recommended July 24 that the agency approve the osteoporosis drug Evista (raloxifene) for use in preventing breast cancer in certain high-risk groups of older women, "HealthDay News" reported. In a vote ...
New study confirms link between breast cancer and hormone therapy.(Drug Safety)
Jul 30, 2007 ... A sharp drop in breast cancer rates from 2003 to 2004 is linked to an even larger drop in women's use of hormone therapy that began around 2000, according to a Kaiser Permanente study in the Aug. 1 issue of the "Journal of the National Cancer Institute" that confirms the connection between ...
Suicide findings question link to antidepressants.(Drug Safety)
Jul 30, 2007 ... Two large new studies in "The American Journal of Psychiatry" suggest that treatment of depression, either with psychotherapy or drugs, reduces the risk of suicide attempts in all age groups, especially during the first months of treatment. The findings raise further questions about ...
EMEA recommends withdrawal of products containing veralipride.(International)(European Agency for the Evaluation of Medicinal Products)(Brief article)
Jul 30, 2007 ... The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorization for medicinal products containing veralipride. EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of veralipride in the treatment of hot flushes associated ...
EMEA toughens warning on Sanofi anti-obesity drug.(International)(European Agency for the Evaluation of Medicinal Products)(Sanofi-Aventis S.A.)(Brief article)
Jul 30, 2007 ... European drug regulators recommended that Acomplia, an anti-obesity pill from French drug maker Sanofi-Aventis, shouldn't be prescribed for patients with depression or taking antidepressants. The European Medicines Agency (EMEA) stopped short of suspending the drug but said July ...
Nigeria files new Pfizer claims.(International)(illegal drug trial case)(Brief article)
Jul 30, 2007 ... Nigeria has accused Pfizer of fraud in a fresh court case filed against the drug firm over its alleged role in the deaths of Nigerian children, BBC News reported July 20. The government earlier withdrew the case, just as it was due to begin in the capital Abuja, to add new ...
Recall of AIDS drug hits world's poor.(International)
Jul 30, 2007 ... A total recall of an important AIDS drug widely used in developing countries has disrupted treatment for tens of thousands of the world's poorest patients, with no clear word from the manufacturer on when shipments will resume, "The New York Times" reported July 21. The recall ...
Inappropriate prescribing for older patients a growing problem.(Labeling/prescribing)(Brief article)
Jul 30, 2007 ... Too many older people are being prescribed too many medicines or the wrong drugs, and more research needs to be done to find out how to fix the problem, say two papers published in "The Lancet" medical journal, "HealthDay News" reported July 12. The complexities of the ...
Medical illiteracy deadly for seniors.(Labeling/prescribing)
Jul 30, 2007 ... New research indicates that difficulty understanding medical information can be deadly, especially in older patients, The Associated Press reported July 23. A study of patients 65 and older found that those who couldn't understand basic written medical instructions were much ...
Thoratec recalls VADs.(Recalls/warnings)(Ventricular Assist Device )(Brief article)
Jul 30, 2007 ... Thoratec Corporation and FDA notified health care professionals and consumers of a Class I Recall of Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver, Catalog No. 20010-0000-032. A Ventricular assist device is a mechanical pump that helps a person's heart that is too weak to ...
Baxter recalls infusion pumps.(Recalls/warnings)(Brief article)
Jul 30, 2007 ... Baxter and FDA notified health care professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or ...
FDA warns Medtronic over its drug-infusion pumps.(Recalls/warnings)(Brief article)
Jul 30, 2007 ... Medical device maker Medtronic has been issued a warning letter by FDA over problems at the company's Minneapolis plant that makes implantable drug infusion and nerve stimulation devices according to "Yahoo News". In a warning letter posted on FDA's Web site on July 17, the ...
Bayer Healthcare recalls glucose monitoring system.(Recalls/warnings)(Brief article)
Jul 30, 2007 ... Bayer Healthcare and FDA notified health care professionals and consumers of a Class I Recall of Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A, the agency stated July 13 in a release. This system is used by diabetic patients to measure the amount of ...
Boston Scientific will settle all pending federal suits.(Litigation/Medical Devices)
Jul 30, 2007 ... Boston Scientific said it agreed to settle all pending federal lawsuits against the company alleging harm from faulty defibrillators and pacemakers for $195 million, well below the sum the company had estimated as its likely liability, "The Wall Street Journal" reported July 14. ...
Fewer stents implanted in June, signaling impact of new studies.(Litigation/Medical Devices)(Survey)(Brief article)
Jul 30, 2007 ... U.S. doctors implanted fewer coronary stents in June than any other month in the last year, according to information from Goodroe Healthcare Solutions, which surveys 75 U.S. hospitals with catheterization facilities for stenting. The survey results indicate that medical studies ...
FDA bonuses to be reviewed; critics say funds not used well.(FDA Management)
Jul 30, 2007 ... FDA is giving workers more than $8 million in bonuses to keep them from defecting to pharmaceutical and other regulated industries, at the same time congressional critics say the money would be better spent on improving safety, "The Washington Post" said July 17. The retention ...
Safety labeling changes approved by CDER--April 2007.(Center for Drug Evaluation and Research)
Jul 30, 2007 ... Below are listed drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. ...