FDA Patient Safety News: Show #46, December 2005

Risk of Suicidality in Children Treated with Strattera

FDA recently alerted health care providers that treatment of children and adolescents with Strattera increases the risk of suicidal thinking. Strattera (atomoxetine) is approved to treat ADHD in patients 6 years and older.

The increased risk of suicidal thinking was identified in a combined analysis of 12 placebo-controlled trials lasting six to eighteen weeks. This analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no reports in children treated with placebo. A similar analysis in adults treated with Straterra for either ADHD or major depressive disorder found no increased risk of suicidality with use of the drug.

A new boxed warning will point out that children who are started on Strattera therapy should be observed closely for suicidal thinking or behaviors, clinical worsening, or unusual changes in behavior. This is especially important during the initial months of therapy or when the dose is changed.

Families should contact their child's doctor if they observe any of these signs.
Eli Lilly, the drug's manufacturer, will also be developing a Patient Medication Guide to provide this information directly to patients and their caregivers.

Additional Information:

FDA MedWatch Safety Alert - Strattera (atamoxetine).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152628.htm


Recall of Enteryx Injections for Gastroesophageal Reflux Disease

FDA recently issued Public Health Notification about serious adverse events, including death, occurring with Enteryx, a product made by Boston Scientific that's used to treat gastroesophageal reflux disease (GERD). Enteryx is a liquid copolymer that's injected into the muscle layer of the lower esophageal sphincter. Shortly after injection, it solidifies into a spongy material that acts as a physical barrier to help prevent reflux. Once injected, the material can not be removed.

The serious adverse events involved unrecognized transmural injections of Enteryx i.e., cases where the injection needle may have penetrated the esophageal wall, injecting the material into the wall of the aorta, the mediastinum and the pleural cavity. In some cases, this was not recognized until several weeks after the injection took place. There were other cases where injury occurred even though the Enteryx was not injected transmurally. These injuries included serious mediastinal events and esophageal stenosis.

The manufacturer of Enteryx, Boston Scientific, has recalled all Enteryx products. Physicians should stop using the products immediately and return unused product to the company.

If it’s suspected that a patient had a transmural injection, then the patient should be carefully monitored for for chest or epigastric pain, flu-like respiratory symptoms, syncope or flank pain at least 30 days.

Even if transmural injection isn’t suspected, patients should still be told keep up with their regularly scheduled appointments and to watch for and report symptoms. If symptoms do occur, x-ray or CT exams should be done to rule out transmural injection. Patients should be told to go to an emergency room immediately if they experience chest pain or syncope.

Additional Information:

FDA Preliminary Public Health Notification: Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM064523


Recall of Enteryx Injections for Gastroesophageal Reflux Disease

FDA recently issued Public Health Notification about serious adverse events, including death, occurring with Enteryx, a product made by Boston Scientific that's used to treat gastroesophageal reflux disease (GERD). Enteryx is a liquid copolymer that's injected into the muscle layer of the lower esophageal sphincter. Shortly after injection, it solidifies into a spongy material that acts as a physical barrier to help prevent reflux. Once injected, the material can not be removed.

The serious adverse events involved unrecognized transmural injections of Enteryx i.e., cases where the injection needle may have penetrated the esophageal wall, injecting the material into the wall of the aorta, the mediastinum and the pleural cavity. In some cases, this was not recognized until several weeks after the injection took place. There were other cases where injury occurred even though the Enteryx was not injected transmurally. These injuries included serious mediastinal events and esophageal stenosis.

The manufacturer of Enteryx, Boston Scientific, has recalled all Enteryx products. Physicians should stop using the products immediately and return unused product to the company.

If it’s suspected that a patient had a transmural injection, then the patient should be carefully monitored for for chest or epigastric pain, flu-like respiratory symptoms, syncope or flank pain at least 30 days.

Even if transmural injection isn’t suspected, patients should still be told keep up with their regularly scheduled appointments and to watch for and report symptoms. If symptoms do occur, x-ray or CT exams should be done to rule out transmural injection. Patients should be told to go to an emergency room immediately if they experience chest pain or syncope.

Additional Information:

Advice for Patients with ENTERYX® for Gastroesophageal Reflux Disease.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064748.htm


Possible Connection between Menactra Meningococcal Vaccine and Guillain Barre Syndrome

Update: CDC MMWR October 20, 2006. "Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. "This report summarizes nine additional GBS cases reported to VAERS during March--September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

...original story...
FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur.

At this point, it isn't known whether these cases of GBS were caused by the vaccine, or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis.

This vaccine has been given to several million people and the number of reported cases so far is about what would be expected in a patient population of this size, even without the vaccine.

However, the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So, FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System.

Additional Information:

Report to the Vaccine Adverse Event Reporting System (VAERS).
https://secure.vaers.org/VaersDataEntryintro.htm


Possible Connection between Menactra Meningococcal Vaccine and Guillain Barre Syndrome

Update: CDC MMWR October 20, 2006. "Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. "This report summarizes nine additional GBS cases reported to VAERS during March--September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

...original story...
FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur.

At this point, it isn't known whether these cases of GBS were caused by the vaccine, or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis.

This vaccine has been given to several million people and the number of reported cases so far is about what would be expected in a patient population of this size, even without the vaccine.

However, the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So, FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System.

Additional Information:

FDA MedWatch Safety Alert - Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135).
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Menactra


New Caution on Using Paxil During Pregnancy

GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil (paroxetine hydrochloride).

The new information summarizes a retrospective epidemiologic study performed by the company. This study suggests that the risk of major congenital malformations in infants born to women who take Paxil during the first trimester may be approximately twice as high as the risk for women taking other antidepressants.

The company is recommending that physicians carefully weigh the potential risks and benefits of using Paxil during pregnancy, and that they discuss these latest findings, along with treatment alternatives, with their patients.

Additional Information:

FDA MedWatch Safety Alert - Paxil (paroxetine) and Paxil HCl CR Controlled Release Tablets.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152310.htm


Preventing Errors with Neuromuscular Blocking Agents

ISMP recently issued a Safety Alert called "Paralyzed by Mistakes," which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren't receiving ventilator support. This can lead to respiratory arrest. Some patients have died or incurred permanent injuries as a result of these errors.

ISMP notes that some of the errors are due to look-alike packaging and labeling. In one case, an ED nurse administered pancuronium instead of flu vaccine because the vials and labeling looked very similar. Look-alike drug names have also caused problems. In one case vancomycin was misread on a faxed medication record as vecuronium.

Giving the neuromuscular blocking agent after the patient is extubated has resulted in serious problems, too. In one case, an infusion bag of vecuronium was left in a patient's room after ventilator support had been removed. The bag was later mistaken as potassium chloride infusion and administered to the patient.

Serious patient injuries have also been caused by the opposite problem i.e., administering the neuromuscular blocking agent too soon, before the patient is intubated.

Some errors have resulted from preparing syringes from a multiple-dose vial and neglecting to label them. In one case, an unlabeled syringe of vecuronium ended up in a supply of saline flush syringes and was given to a 3-year old child.

Unsafe storage is another cause of serious mistakes. Seven infants in a hospital nursery received atracurium instead of hepatitis vaccine after an anesthesiologist placed a vial of atracurium in the nursery refrigerator near vaccine vials of similar appearance.

Not knowing enough about the drug's action can also contribute to errors. In one case, a nurse mistakenly administered vecuronium to an oncology patient who was not being ventilated, and the patient died. Had the nurse realized that the drug would paralyze the respiratory muscles, the error might have been avoided.

ISMP reminds health care practitioners that neuromuscular blocking agents are high-alert drugs and should receive your highest attention. Their alert suggests twelve ways to prevent these kinds of errors. Here are some of them:

• Limit access to the drugs, allowing floor stock only in the OR, ED and critical care units.

• Segregate storage, keeping boxes containing these agents separate in refrigerators and on shelves.

• Place warning labels on vials, syringes, infusion bags and boxes that say "Warning: paralyzing agent, causes respiratory arrest."

• Before dispensing and administering these drugs, require an independent double check of the drug against the actual order.

• And after the patient has been extubated or the drug has been discontinued, promptly isolate vials, syringes and infusion bags containing the drug in a sequestered bin for pharmacy pickup.

Additional Information:

ISMP Medication Safety Alert - Paralyzed by mistakes - Preventing errors with neuromuscular blocking agents. September 22, 2005.
http://www.ismp.org/MSAarticles/20050922.htm


Drug Name Confusion: Toprol-XL, Topamax, Tegretol and Tegretol-XR

Medication errors can sometimes occur when drug names look or sound alike. For example, FDA has received reports of mix-ups between several drugs that all begin with the letter "T": Toprol-XL, a beta-blocker, Topamax, which is used to treat epilepsy and prevent migraine, and Tegretol or Tegretol-XR, another anti-epileptic.

These mix-ups have occurred when prescriptions for these products were poorly written, misinterpreted, or incorrectly labeled or dispensed. Computer selection errors also played a role. In a number of cases, patients suffered adverse events because of these errors, and in some cases they had to be hospitalized.

The similarity between the product names was reported to be a key factor in these errors. Also, these drugs are often stored close to each other on pharmacy shelves and there's some overlap between the available dosage strengths of these products.

The manufacturers of Toprol-XL, Topamax, and Tegretol/Tegretol-XR recently sent letters to healthcare professionals and pharmacists, alerting them to this name confusion and suggesting ways to reduce the potential for dispensing errors. For example, prescribers should use both brand and generic name, as well as indication, when writing prescriptions. Pharmacists could physically separate the products on stock shelves and use "shelf talkers" as needed.

Additional Information:

FDA MedWatch Safety Alert - Toprol-XL (metoprolol succinate) extended release tablets/Topamax (topiramate) tablets/Tegretol (carbamazepine)/Tegretol (carbamazepine extended release).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152631.htm


New Caution on Using Paxil During Pregnancy

GlaxoSmithKline has notified healthcare professionals that new precautionary information is being added to the labeling for the antidepressant Paxil (paroxetine hydrochloride).

The new information summarizes a retrospective epidemiologic study performed by the company. This study suggests that the risk of major congenital malformations in infants born to women who take Paxil during the first trimester may be approximately twice as high as the risk for women taking other antidepressants.

The company is recommending that physicians carefully weigh the potential risks and benefits of using Paxil during pregnancy, and that they discuss these latest findings, along with treatment alternatives, with their patients.

Additional Information:

FDA MedWatch Safety Alert - Paroxetine HCl - Paxil and Generic Paroxetine.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152062.htm


Possible Connection between Menactra Meningococcal Vaccine and Guillain Barre Syndrome

Update: CDC MMWR October 20, 2006. "Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. "This report summarizes nine additional GBS cases reported to VAERS during March--September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

...original story...
FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur.

At this point, it isn't known whether these cases of GBS were caused by the vaccine, or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis.

This vaccine has been given to several million people and the number of reported cases so far is about what would be expected in a patient population of this size, even without the vaccine.

However, the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So, FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System.

Additional Information:

CDC MMWR October 20, 2006 / 55(41);1120-1124 Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States. June 2005--September 2006.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5541a2.htm?s_cid=mm5541a2_e


Possible Connection between Menactra Meningococcal Vaccine and Guillain Barre Syndrome

Update: CDC MMWR October 20, 2006. "Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. "This report summarizes nine additional GBS cases reported to VAERS during March--September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

...original story...
FDA and CDC are alerting health care providers and consumers about six reports of Guillain-Barre Syndrome following administration of Menactra, a Meningococcal vaccine manufactured by Sanofi Pasteur.

At this point, it isn't known whether these cases of GBS were caused by the vaccine, or were just coincidental. At the present time, there are no changes in the recommendations for vaccination against meningitis.

This vaccine has been given to several million people and the number of reported cases so far is about what would be expected in a patient population of this size, even without the vaccine.

However, the timing of these six events causes some concern. And since vaccine adverse events aren't always reported, there may be additional cases that we don't know about. So, FDA and CDC are asking anyone who knows of GBS occurring after Menactra administration to report this to the Vaccine Adverse Event Reporting System.

Additional Information:

FDA MedWatch Safety Alert - Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135). October 23, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152369.htm



FDA Patient Safety News is available at www.fda.gov/psn