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December 2007 FDA "Patient Safety News" Videos For Doctors Online 2007-12-09 23:06:00 Covers Sprint Fidelis Cardiac Leads, Byetta, And Bisphosphonates Such As Fosamax (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences. Subjects covered in the December 2007 edition of the FDA Patient Safety News include the following: Recall of Sprint Fidelis Cardiac Leads Possibility of Pancreatitis in Patients Taking Byetta Possible Link between Bisphosphonates and Atrial Fibrillation Caution on Viracept in Children and Pregnant Women One can find more information about this December 2007 PSN edition and the series in general on the Patient Safety News secti ...

FDA Expected To Comment On Its Safety Evaluation Of Nexium And Prilosec In December 2007 2007-12-07 14:08:52 Agency's Follow-Up On Its August 2007 "Early Communication" About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in early August 2007 the FDA and Health Canada raised concerns about possible serious cardiac events in patients using Nexium and Prilosec, made by AstraZeneca (AZN), which are used for the treatment of gastroesophageal reflux disease (GERD) and esophageal erosions, as well as for maintenance of healing erosions of the esophagus. At that time the FDA had said it should have further guidance for doctors and patients concerning these two popular heartburn, or stomach-acid, drugs in approximately 90 days. Now, almost four months after the FDA released this so-called "early communication" about Nexium (esomeprazole) and Prilosec (omeprazole), we finally get an indication that the FDA may be getting close to providing its more definitive advice on these two drugs, w ...

Mixed Reactions To Avandia's Revised Warning In November 2007 About Risk Of Heart Attacks 2007-12-06 11:54:00 Drug Safety Experts And FDA Officials Discuss Avandia And The New Black-Box Warning (Posted by Tom Lamb at DrugInjuryWatch.com) On November 14, 2007 the FDA issued a news release entitled "FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia", which carried the sub-heading "Agency says drug to remain on market, while safety assessment continues".  By this means, the FDA announced that GlaxoSmithKline Plc (GSK), the manufacturer of Avandia (rosiglitazone), would add new safety information about a potential increased risk for heart attacks to the "black-box" warning part of the current Avandia package insert, or label. As pointed out in a November 15, 2007 Bloomberg article, "Glaxo's Avandia Gets Less Stringent Warning in U.S.", this action by the FDA was not as strong as that taken by drug regulators in Canada and the European Union a bit earlier:Health Canada withdrew approval for Avandia as a stand-alone therapy ...

November 2007 FDA Advisory Panel Recommends That Serevent And Advair Get Stronger Warnings About Use By Children 2007-11-29 16:29:34 Some Panel Members Want Serevent Withdrawn From Market; FDA And GSK Say Asthma Drug Recall Is Not Appropriate (Posted by Tom Lamb at DrugInjuryWatch.com) On November 28, 2007 an FDA pediatric advisory panel recommended that the safety warnings on Serevent and Advair needed to be strengthened in order to emphasize the increased risk of hospitalization and death for children using these two asthma drugs from GlaxoSmithKline PLC (GSK). For some information about the extent of use by children, we get this sales information about  Advair and Serevent from a November 29, 2007 article, "New Warnings Sought For Two Asthma Drugs", published by The Wall Street Journal:Advair, known as Seretide outside the U.S., is Glaxo's biggest-selling drug, with global sales of $6.1 billion last year. Serevent sales totaled $538 million. The company estimates 13.3% of Advair and 3% of Serevent prescriptions were for children. According to an FDA analysis of data from Verispan, 779,006 U.S. ... Children

FDA Report Says Popular Asthma Drugs Serevent And Advair May Have Deadly Side Effects For Some Children 2007-11-26 17:06:18 November 2007 Advisory Panel Meeting To Consider Safety of These Glaxo Drugs As Well As Novartis' Foradil (Posted by Tom Lamb at DrugInjuryWatch.com) An October 24, 2007 FDA staff report about Serevent (SUBJECT: 1-year Post-Pediatric Exclusivity Postmarketing Adverse Event Review) concluded that this inhaled beta-2 agonist asthma drugs as well as Advair "may have an unfavorable risk-benefit ratio" for children's asthma. The October 2007 FDA staff report was prepared in advance of a meeting of an advisory panel of pediatricians later this week being convened to consider the safety of Serevent and Advair (made by GlaxoSmithKline PLC), both of which contain the active ingredient salmeterol, as well as another asthma drug, Foradil (made by Novartis AG and marketed in the U.S. by Schering-Plough Corp.), which contains the active ingredient formoterol. In relevant part, for this asthma drug safety report FDA staff reviewed their adverse event reporting system database and fou ... Children

FDA Announces In November 2007 That It Will Investigate Possible Link Between Maxipime And Increased Risk Of Death 2007-11-20 09:18:00 A Medical Journal Article Published In May 2007 Suggested This Emerging Drug Safety Issue; Why Was There A Six-Month Delay In Starting This FDA Investigation? (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-November 2007 the FDA sent an MedWatch Email Alert to inform the public about an emerging drug safety issue involving Maxipime (Cefepime), an injectable antibiotic that was approved by the FDA in 1996.  In summary, the FDA announced the start of its investigation into a possible increased risk of death associated with Maxipime use, and said that their safety evaluation should take about four months to complete.  Maxipime is manufactured by Bristol-Myers Squibb Co. (BMY).  Maxipime is marketed in the U.S. by Elan Corp. PLC (ELN). More detail is set forth in the FDA's "Early Communication About an Ongoing Safety Review Cefepime (marketed as Maxipime)", which the agency issued in November 2007:An article in a recent issue of The Lancet Infectious Disease ...

Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market? 2007-11-09 11:03:44 One Wonders Whether GSK Might Do A "Soft" Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years (Posted by Tom Lamb at DrugInjuryWatch.com) Avandia (rosiglitazone) is a prescription drug from GlaxoSmithKline (GSK) approved by the FDA in 1999 to treat Type 2 diabetes.  As many people are aware now, while Avandia might have helped diabetic patients in some regards, it seems that this benefit comes at an increased risk of developing serious heart-related side effects including heart attacks and strokes. The Avandia safety story started for most of us in May 2007, as follows:On May 21, 2007 the Los Angeles Times published an Associated Press (AP) article entitled "Diabetes drug linked to heart attack risk" which broke the story about a new analysis of Avandia data that was published online earlier this same day by the New England Journal of Medicine (NEJM).  The new Avandia article, "Effect of Rosiglitazone o ...

Trasylol Sales In U.S. And Canada Suspended Temporarily By Bayer In Early November 2007 2007-11-05 11:29:29 Market Withdrawal Or Recall Of Trasylol Seems Possible As Bayer Waits For Final Data From Halted BART Study (Posted by Tom Lamb at DrugInjuryWatch.com) On November 5, 2007 the FDA announced and Health Canada announced that sales of Bayer AG' s anti-bleeding drug Trasylol (aprotinin) would be suspended temporarily in the U.S. and Canada while investigations continued about whether Trayslol is linked to a higher risk of death than competing heart surgery drugs. As we had reported previously, the FDA has been reviewing the safety of Trasylol since early 2006:In mid-February 2006 the FDA issued a Public Health Advisory informing doctors and patients that the agency was evaluating the safety of Bayer AG's heart surgery drug Trasylol (aprotinin injection) after new studies had linked it to higher risks of kidney problems, heart attacks, and strokes.  At the end of February 2006, a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect ...

New Information From FDA On Alleged Problems With Ketek Safety Study 3014 2007-11-01 10:20:00 October 2007 FDA Letter Says Aventis Did Not Follow Regulations And Statutory Requirements; Company Contends Study Conducted In Good Faith (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA posted on its web site a copy of an 11-page "Warning Letter" to Sanofi-Aventis (SNY) about problems with Ketek Study 3014. In her October 25, 2007 Wall Street Journal article, "FDA Says Aventis Failed To Act on Ketek Drug Fears", Anna Wilde Mathews provided this summary the FDA's Ketek letter: In yesterday's letter, the FDA said visits from an Aventis contractor and the drug maker's own audits documented "serious protocol violations and regulatory noncompliance by multiple clinical investigators." The agency said it was "unable to find evidence" that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified inve ...

Is This What Medtronic's March 21, 2007 "Dear Doctor" Letter Said About Sprint Fidelis Lead Problems? 2007-10-26 16:22:23 One Person Took The Impression That Medtronic Was Trying To Lay Blame For Lead Wire Failures On Those Physicians Who Were Doing The Defibrillator Implants (Posted by Tom Lamb at DrugInjuryWatch.com) To start, our thanks to a fellow in Florida who was kind enough to share with us what he found as a result of some investigation into that hard-to-find March 21, 2007 "Dear Doctor" letter about problems with Medtronic's Sprint Fidelis defibrillator leads. Unfortunately, his motivation came from the fact that he has one of the recalled Sprint Fidelis leads implanted currently.  The following material comes from an April 8, 2007 article posted on a somewhat obscure blog called Random Thoughts on Pacemakers & Personal Finance that this fellow found after some looking-around on the Internet:... On March 21st, Medtronic issued a "Dear Doctor" letter concerning higher than expected conductor fracture rates with the Sprint Fidelis lead. The Sprint Fidelis is Medtr ...

Cephalon Added Warning To Provigil Label About Serious Skin Reactions In August 2007 2007-10-24 16:01:44 A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA sent an email alert to inform doctors and other healthcare providers that the drug company Cephalon issued a revised package insert, or label, for Provigil (modafinil) in August 2007. According to this October 2007 FDA alert about Provigil: Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder....  Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Ra ...

Congressman Waxman Sends A Letter To FDA Requesting Medtronic Sprint Fidelis Information 2007-10-23 09:02:18 Committee on Oversight and Government Reform Wants To Know What The FDA Knew About Defibrillator Lead Wire Fractures And When They Knew It (Posted by Tom Lamb at DrugInjuryWatch.com) On October 22, 2007, as Chairman of the Committee on Oversight and Government Reform, Congressman Henry Waxman (29th District, CA) sent a letter to FDA Commissioner Andrew von Eschenbach about the recently recalled Medtronic Sprint Fidelis defibrillator lead wires. As characterized on the web site for this Committee, Waxman's letter is "requesting information about the Agency’s approval of Medtronic’s Sprint Fidelis leads, which are components used in implantable cardiac defibrillators." A reading of the October 22, 2007 Waxman letter to the FDA, however, reveals that the Congressman is equally interested in learning about when and what Medtronic, Inc. reported to the FDA about the failures of its Sprint Fidelis leads. In Waxman's October 22 letter we find these requests for information: Plea ...

Children And Young Adults Apparently Have A Higher Risk Of Their Sprint Fidelis Heart Wire Fracturing 2007-10-19 08:35:25 This Medtronic Defibrillator Lead Line Was Particularly Popular In Younger Patients Due To Its Smaller Size (Posted by Tom Lamb at DrugInjuryWatch.com) In an October 19, 2007 article, "Heart Wires May Pose More Risk for the Young", Wall Street Journal (WSJ) reporters Anna Wilde Mathews and Thomas M. Burton continued to develop the evolving story about the Medtronic Sprint Fidelis recall.  This latest news report concerns children and younger adults who have defibrillators with Sprint Fidelis leads. Here is what we learned from this WSJ article about pediatric patients and why their risk of experiencing a defibrillator malfunction is higher than older patients:[Medtronic Inc.] said that of the 268,000 Sprint Fidelis leads implanted, 2,085 were in patients under the age of 21.... Preliminary data from physicians at 32 institutions who specialize in treating pediatric patients and adults with congenital heart disease showed a fracture rate of 6.7% among 569 patients wit ... Children

FDA Alerts Doctors About Diabetes Drug Byetta And Acute Pancreatitis Reports 2007-10-19 07:14:00 Package Insert Will Be Changed To Include Stronger Warning About This Potentially Fatal Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) On October 16, 2007 the FDA issued an alert to doctors informing them that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. From this October 2007 FDA document, "Information for Healthcare Professionals - Exenatide (marketed as Byetta)", we get some breakdown of those 30 adverse reaction reports: FDA said there is evidence that suggests an association between Byetta and acute pancreatitis "in some of these cases." In six patients the pancreatitis symptoms began or worsened soon after Byetta dose was increased from 5 mcg twice daily to 10 mcg twice daily. 22 of the 30 reports indicated that the patients improved after discontinuing exenatide, i.e., "de-challenge". Details in three reports indicated that the symptoms of acute pan ...

Medtronic Sprint Fidelis Wire Leads Fracturing In Defibrillators May Have Caused Five Deaths 2007-10-16 15:57:33 Events Leading Up To October 2007 FDA Recall Include A Little Noticed March 2007 "Dear Doctor" Letter And July 2007 Medical Journal Article About Model 6949 (Posted by Tom Lamb at DrugInjuryWatch.com) An October 16, 2007 article in The Wall Street Journal about the Fidelis Sprint leads recall presented the current situation:In announcing the recall early yesterday, Medtronic said that its Sprint Fidelis leads have broken at a rate apparently higher than that of competing leads, including another from Medtronic.... When the lead fractures, it can have serious consequences: Some patients can receive unnecessary and massive shocks, sometimes compared to the jolt of sticking a fork in a light socket. Other patients don't get the shock when they do need it to save their lives after cardiac arrest. Overall, five patients so far have died in cases Medtronic says may be related to the flaw. So far, 2.3% of the implanted leads have malfunctioned over a 30-month period studied b ...