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Articles from Drug Injury Watch

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 ...

How Should Drug Companies And Their Ad Agencies Respond To Safety Signals? 2007-10-15 16:25:33 Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward (Posted by Tom Lamb at DrugInjuryWatch.com) The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor: What Do You Say?" which carried this intriguing sub-title: "The first safety signal is detected. Proof or disproof is literally years away. What has to happen so no patient will say, 'You hid the risk'?" For a lead-in on this piece, however, we draw from an October 15, 2007 post by Ed Feather "The Vioxx Moment" over at the ART + science: the PARTNERS+simons Blog:Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine, uses the terms “the Vioxx moment” and “the Avandia moment” in his September 2007 “From the Editor” column. He describes these as “the moment when a safety signal has been detected on a drug, and no one yet knows for certain whether it is real or not – the moment when pharma companie ...

How Should Drug Companies And Their Ad Agencies Respond To Safety Signals? 2007-10-15 16:25:33 Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward (Posted by Tom Lamb at DrugInjuryWatch.com) The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor: What Do You Say?" which carried this intriguing sub-title: "The first safety signal is detected. Proof or disproof is literally years away. What has to happen so no patient will say, 'You hid the risk'?" For a lead-in on this piece, however, we draw from an October 15, 2007 post by Ed Feather "The Vioxx Moment" over at the ART + science: the PARTNERS+simons Blog:Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine, uses the terms “the Vioxx moment” and “the Avandia moment” in his September 2007 “From the Editor” column. He describes these as “the moment when a safety signal has been detected on a drug, and no one yet knows for certain whether it is real or not – the moment when pharma companie ...

Health Canada Provides 2007 Update On Reports Of Suspected Meridia Adverse Reactions 2007-10-09 16:50:12 Meridia Can Increase Blood Pressure And Heart Rate Leading To Possible Serious Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) The Canadian Adverse Reaction Newsletter (CARN) released in October 2007 (Volume 17, Issue 4) includes an article about the anti-obesity drug Meridia (sibutramine), "Contraindicated use of sibutramine and cardiovascular adverse reactions".  This article updates us on the safety profile of Meridia, which is made for the Canadian market by Abbott Laboratories Ltd. As background, in March 2002 Meridia was the subject of a Health Canada investigation which resulted in this February 2003 report on the safety of Meridia. This October 2007 Canadian Adverse Reaction Newsletter article updates that Meridia safety profile report with this information:Health Canada continues to receive reports of ARs in patients using sibutramine who have contraindications. From Jan. 1, 2001, to May 31, 2007, Health Canada received 65 reports of card ... Health

Health Canada Provides 2007 Update On Reports Of Suspected Meridia Adverse Reactions 2007-10-09 16:50:12 Meridia Can Increase Blood Pressure And Heart Rate Leading To Possible Serious Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) The Canadian Adverse Reaction Newsletter (CARN) released in October 2007 (Volume 17, Issue 4) includes an article about the anti-obesity drug Meridia (sibutramine), "Contraindicated use of sibutramine and cardiovascular adverse reactions".  This article updates us on the safety profile of Meridia, which is made for the Canadian market by Abbott Laboratories Ltd. As background, in March 2002 Meridia was the subject of a Health Canada investigation which resulted in this February 2003 report on the safety of Meridia. This October 2007 Canadian Adverse Reaction Newsletter article updates that Meridia safety profile report with this information:Health Canada continues to receive reports of ARs in patients using sibutramine who have contraindications. From Jan. 1, 2001, to May 31, 2007, Health Canada received 65 reports of card ... Health

Bisphosphonate Safety Update: FDA Is Investigating Link With Atrial Fibrillation In October 2007 2007-10-04 13:13:42 Merck Addresses Cases Of Fosamax-induced Osteonecrosis Of The Jaw, And Three Reports Of ONJ Are Subject Of A Medical Journal Article (Posted by Tom Lamb at DrugInjuryWatch.com) This article is a review of recent reports about the safety of bisphosphonates, with an emphasis on Merck's Fosamax and its association with osteonecrosis of the jaw (ONJ). We start however with the emerging issue of a possible link between bisphosphonates and the heart condition atrial fibrillation. In October 2007 the FDA issued an Early Communication of an Ongoing Safety Review entitled "Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)" which is largely based on the following:An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of ser ...

Bisphosphonate Safety Update: FDA Is Investigating Link With Atrial Fibrillation In October 2007 2007-10-04 13:13:42 Merck Addresses Cases Of Fosamax-induced Osteonecrosis Of The Jaw, And Three Reports Of ONJ Are Subject Of A Medical Journal Article (Posted by Tom Lamb at DrugInjuryWatch.com) This article is a review of recent reports about the safety of bisphosphonates, with an emphasis on Merck's Fosamax and its association with osteonecrosis of the jaw (ONJ). We start however with the emerging issue of a possible link between bisphosphonates and the heart condition atrial fibrillation. In October 2007 the FDA issued an Early Communication of an Ongoing Safety Review entitled "Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)" which is largely based on the following:An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of ser ...

FDA Updates Exjade Adverse Drug Reaction Numbers In Its First Drug-Safety Newsletter 2007-09-25 17:00:00 FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at DrugInjuryWatch.com) In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox).  This medication is an orally active chelating agent that removes excess iron in patients undergoing regular blood transfusions. Marketed in the U.S. by Novartis AG (NVS), Exjade was approved by the FDA for sale in 1995. Adverse drug reaction reports associated with Exjade were the subject of a May 22, 2007 article in The Wall Street Journal, "FDA Warns Novartis's Exjade Could Cause Kidney Failure", which included this information:In a May 14 letter to health-care professionals posted Tuesday to the FDA's Web site, Novartis said it received reports of kidney failure, some with a fatal out ...

FDA Updates Exjade Adverse Drug Reaction Numbers In Its First Drug-Safety Newsletter 2007-09-25 17:00:00 FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at DrugInjuryWatch.com) In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox).  This medication is an orally active chelating agent that removes excess iron in patients undergoing regular blood transfusions. Marketed in the U.S. by Novartis AG (NVS), Exjade was approved by the FDA for sale in 1995. Adverse drug reaction reports associated with Exjade were the subject of a May 22, 2007 article in The Wall Street Journal, "FDA Warns Novartis's Exjade Could Cause Kidney Failure", which included this information:In a May 14 letter to health-care professionals posted Tuesday to the FDA's Web site, Novartis said it received reports of kidney failure, some with a fatal out ...

Sleep Disorder Narcolepsy Drug Provigil Associated With Serious Skin Reactions 2007-09-20 17:04:26 FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). This medication, made by the drug company Cephalon, Inc., is prescribed to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea / hypopnea syndrome (OSAHS), and shift work sleep disorder. Based on postmarketing reviews of adverse event reports made to the FDA, the serious skin reactions associated with Provigil are toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and erythema multiforme (EM), as well as drug rash with eosinophilia and systemic symptoms (DRESS). According to the Provigil article about serious skin reactions published ...

Sleep Disorder Narcolepsy Drug Provigil Associated With Serious Skin Reactions 2007-09-20 17:04:26 FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). This medication, made by the drug company Cephalon, Inc., is prescribed to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea / hypopnea syndrome (OSAHS), and shift work sleep disorder. Based on postmarketing reviews of adverse event reports made to the FDA, the serious skin reactions associated with Provigil are toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and erythema multiforme (EM), as well as drug rash with eosinophilia and systemic symptoms (DRESS). According to the Provigil article about serious skin reactions published ...

FDA To Finally Study Possible Increased Heart Risks Caused By Attention Deficit Medications 2007-09-18 08:54:21 The Safety Profile Of Adderall, Concerta, Ritalin, Dexedrine And All Other ADHD / ADD Drugs Will Be Reviewed (Posted by Tom Lamb at DrugInjuryWatch.com) In a September 17, 2007 FDA News article titled "AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications" we learned that the safety of Adderall, Concerta, Ritalin, and Dexedrine -- as well as all other attention deficit hyperactivity disorder (ADHD) and attention deficit disorder (ADD) drugs -- will be finally be reviewed reviewed. In more detail, the FDA will collaborate with the Agency for Healthcare Research and Quality (AHRQ) to examine clinical data regarding 500,000 children and adults who have used ADHD / ADD drugs in the past to determine these drugs cause an increased risk of heart attacks, strokes, or other serious cardiovascular problems.  The study is expected to take about two years to complete. As stated in the September 17 FDA News item:"Case reports have d ...

FDA To Finally Study Possible Increased Heart Risks Caused By Attention Deficit Medications 2007-09-18 08:54:21 The Safety Profile Of Adderall, Concerta, Ritalin, Dexedrine And All Other ADHD / ADD Drugs Will Be Reviewed (Posted by Tom Lamb at DrugInjuryWatch.com) In a September 17, 2007 FDA News article titled "AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications" we learned that the safety of Adderall, Concerta, Ritalin, and Dexedrine -- as well as all other attention deficit hyperactivity disorder (ADHD) and attention deficit disorder (ADD) drugs -- will be finally be reviewed reviewed. In more detail, the FDA will collaborate with the Agency for Healthcare Research and Quality (AHRQ) to examine clinical data regarding 500,000 children and adults who have used ADHD / ADD drugs in the past to determine these drugs cause an increased risk of heart attacks, strokes, or other serious cardiovascular problems.  The study is expected to take about two years to complete. As stated in the September 17 FDA News item:"Case reports have d ...

Natrecor Is Associated With Increased Risk Of Acute Renal Failure And Death 2007-09-14 11:15:00 Questions About Safety Of Natrecor Continue, With No Apparent Resolution Any Time Soon (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in June 2007 Scios, Inc. announced it had started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)".  At the time, Scios did not mention when this Natrecor safety trial would be completed nor when its results would be available. As background, the safety profile of Natrecor has been a matter of much debate since a prominent heart doctor, Dr. Jonathan Sackner-Bernstein, published two reports in 2005 warning that Natrecor use was possibly linked to significantly increased rates of kidney problems and death. Over time, we have monitored developments regarding the safety of Natrecor, including these two reports among other: Natrecor: Is Controversial J&J Hear ...

Natrecor Is Associated With Increased Risk Of Acute Renal Failure And Death 2007-09-14 11:15:00 Questions About Safety Of Natrecor Continue, With No Apparent Resolution Any Time Soon (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in June 2007 Scios, Inc. announced it had started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)".  At the time, Scios did not mention when this Natrecor safety trial would be completed nor when its results would be available. As background, the safety profile of Natrecor has been a matter of much debate since a prominent heart doctor, Dr. Jonathan Sackner-Bernstein, published two reports in 2005 warning that Natrecor use was possibly linked to significantly increased rates of kidney problems and death. Over time, we have monitored developments regarding the safety of Natrecor, including these two reports among other: Natrecor: Is Controversial J&J Hear ...