FDA Patient Safety News: Show #70, December 2007

First Rapid Test for Bacterial Contamination in Platelets

FDA recently cleared for marketing the first rapid test to detect bacterial contamination in blood platelets before transfusion. The test, called the Platelet Pan Genera Detection (PGD) Test System, was developed by Verax Biomedical Inc.

Bacterial contamination of platelets is the leading infectious cause of patient deaths from transfusions. To reduce the risk of transfusing contaminated platelets, blood centers typically culture samples of the platelets 24 hours after donation and then read the cultures within another 24 hours to determine if the units are contaminated. But in some cases, the number of bacteria present at the time of the culture may be so low that they cannot be detected.

Using the new test, a sample can be prepared, processed and read in 30 minutes, so the platelets can be retested closer to the time they will be used. That way, if bacteria are present, they will have multiplied and be easier to detect. This provides additional assurance that the platelets are free from bacterial contamination.

Additional Information:

FDA Press Release. FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets. September 18, 2007.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108986.htm


Recall of Sprint Fidelis Cardiac Leads

Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients.

Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured.

The affected products are Sprint Fidelis Models 6930, 6931, 6948, and 6949. They are used with implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D).

Medtronic is advising physicians to stop implanting the leads and to return unused leads to the company. FDA and Medtronic are not recommending prophylactic removal of the leads in most patients, because the risk of removing the lead exceeds the small risk of a fracture.

In addition, the company recommends reprogramming the device to monitor the patient more effectively for potential problems, and to provide an audible alert if a lead does fracture.

Patients who have the Sprint Fidelis lead should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should also recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients think they have a Sprint Fidelis lead, or if they do not know the model of their lead, they should contact their doctor.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Sprint Fidelis Defibrillator Leads. October 16, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152658.htm


Recall of Sprint Fidelis Cardiac Leads

Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients.

Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured.

The affected products are Sprint Fidelis Models 6930, 6931, 6948, and 6949. They are used with implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D).

Medtronic is advising physicians to stop implanting the leads and to return unused leads to the company. FDA and Medtronic are not recommending prophylactic removal of the leads in most patients, because the risk of removing the lead exceeds the small risk of a fracture.

In addition, the company recommends reprogramming the device to monitor the patient more effectively for potential problems, and to provide an audible alert if a lead does fracture.

Patients who have the Sprint Fidelis lead should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should also recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients think they have a Sprint Fidelis lead, or if they do not know the model of their lead, they should contact their doctor.

Additional Information:

Medtronic, Inc. Important Information About the Sprint Fidelis® Defibrillator Lead. October 2007.
http://www.medtronic.com/fidelis/


Possibility of Pancreatitis in Patients Taking Byetta

FDA is alerting healthcare professionals that Byetta (exenatide) may be associated with acute pancreatitis in some patients. Byetta is administered subcutaneously to treat type 2 diabetes.

FDA has reviewed 30 reports of acute pancreatitis in patients taking Byetta. Twenty-one were hospitalized, five of them with serious complications. Twenty-two of the patients improved after discontinuing the drug.

Practitioners should be alert to the signs and symptoms of pancreatitis in patients taking Byetta. If pancreatitis is suspected, discontinue the drug. If the diagnosis is confirmed, do not restart Byetta unless an alternative cause for the pancreatitis is identified.

Patients taking Byetta should be cautioned to promptly seek medical care if they experience symptoms of pancreatitis, such as persistent and severe abdominal pain, possibly accompanied by vomiting.

The manufacturer of Byetta, Amylin Pharmaceuticals, has agreed to include information about pancreatitis in the Precautions section of the drug's labeling.

Additional Information:

FDA MedWatch Safety Alert. Byetta (exenatide). October 16, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150839.htm


Severe Adverse Events with Ultrasound Micro-bubble Contrast Agents

FDA is alerting healthcare professionals about serious cardiopulmonary reactions from the ultrasound micro-bubble contrast agents Definity or Optison. These products are used during echocardiography to enhance a cardiac image.

Eleven deaths and about 200 serious reactions have been reported. Four of the 11 deaths were caused by cardiac arrest, either during administration of the contrast agent or within 30 minutes afterwards. Most of the serious but non-fatal reactions also occurred in this time frame. Many of these reports describe symptoms suggestive of anaphylactoid reactions, including dyspnea or urticaria. Other reports describe cardiopulmonary reactions such as cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias, cardiac ischemia, hypotension, respiratory distress and oxygen desaturation, without signs or symptoms of an allergic reaction.

Because of this, the labeling for Definity and Optison will now warn about the risks of both cardiopulmonary and hypersensitivity reactions. The labeling will recommend monitoring vital signs, cardiac rhythm and oxygen saturation, and having equipment for resuscitation and trained personnel readily available.

In addition, these products will now be contraindicated in patients with unstable cardiopulmonary status, such as those with unstable angina, acute myocardial infarction, respiratory failure, or congestive heart failure that's recently worsened.

Additional Information:

FDA MedWatch Safety Alert. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection). October 12, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152686.htm


Possible Link between Bisphosphonates and Atrial Fibrillation

FDA has issued an early communication to healthcare professionals about a possible association between bisphosphonate drugs, which are used to treat osteoporosis, and atrial fibrillation. This issuance is part of FDA's commitment to keep the public informed about ongoing safety reviews of drugs, even when the evidence isn't conclusive.

In this case, the communication is based on two studies of women treated with the bisphosphonates Reclast (zoledronic acid) and Fosamax (alendronate). They were reported in the May 3, 2007 issue of the New England Journal of Medicine.

In both studies, more women who received the bisphosphonates developed serious atrial fibrillation than those who received placebos. There was no significant difference between the two groups in the rate of non-serious fibrillation.

FDA has reviewed these studies, along with premarket studies and postmarketing reports on bisphosphonate drugs, and at this point, it is not clear how the data on serious atrial fibrillation should be interpreted. Because of this uncertainty, FDA is not recommending that healthcare providers or patients change the prescribing or use of these drugs at this time.

FDA is gathering additional data that will allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates. As soon as the evaluation is finished, which may take up to 12 months, FDA will inform the public about the results and any new recommendations on prescribing or using these drugs.

Additional Information:

FDA MedWatch Safety Alert. Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150837.htm


Preventing Meningitis in Children with Cochlear Implants

FDA is reminding healthcare practitioners about the importance of vaccinating children with cochlear implants against bacterial meningitis caused by Streptococcus pneumoniae. Two deaths from meningitis have been reported over the past year in children with cochlear implants. Neither of them had completed the recommended vaccinations against pneumococcus.

Many parents of cochlear implant patients are not getting the message about immunizing these children against pneumococcus. A recent survey at Johns Hopkins revealed that despite repeated efforts to educate parents, up to 40 percent did not know their child's vaccination status. This suggests that at least some cochlear implant patients are not getting vital preventive care that can reduce the risk of a potentially life-threatening illness.

To improve this situation, there are several recommendations that healthcare professionals should follow. Here are a few:

• When caring for patients who have or will be getting cochlear implants, review their vaccination records to be sure they are current on all the immunizations recommended by CDC for this special patient population. Note that CDC considers children with cochlear implants as a high-risk group when it comes to invasive pneumococcal infections.

• Teach parents and caregivers to recognize and report the signs of meningitis. It is important to identify and treat this illness promptly in order to avoid permanent neurological damage. Early signs of meningitis may include high fever, headache, stiff neck, nausea or vomiting, photophobia, somnolence, confusion, ear pain and ear infection. Young children with meningitis can be sleepy, cranky and eat less.

• Diagnose and treat middle ear infections promptly. In some of the cases reported to FDA, patients with meningitis had shown signs of otitis media prior to the implant surgery or before the meningitis developed. According to the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients.

• Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants.

Additional Information:

FDA MedWatch Safety Alert. Cochlear Implants. October 10, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152434.htm


Preventing Meningitis in Children with Cochlear Implants

FDA is reminding healthcare practitioners about the importance of vaccinating children with cochlear implants against bacterial meningitis caused by Streptococcus pneumoniae. Two deaths from meningitis have been reported over the past year in children with cochlear implants. Neither of them had completed the recommended vaccinations against pneumococcus.

Many parents of cochlear implant patients are not getting the message about immunizing these children against pneumococcus. A recent survey at Johns Hopkins revealed that despite repeated efforts to educate parents, up to 40 percent did not know their child's vaccination status. This suggests that at least some cochlear implant patients are not getting vital preventive care that can reduce the risk of a potentially life-threatening illness.

To improve this situation, there are several recommendations that healthcare professionals should follow. Here are a few:

• When caring for patients who have or will be getting cochlear implants, review their vaccination records to be sure they are current on all the immunizations recommended by CDC for this special patient population. Note that CDC considers children with cochlear implants as a high-risk group when it comes to invasive pneumococcal infections.

• Teach parents and caregivers to recognize and report the signs of meningitis. It is important to identify and treat this illness promptly in order to avoid permanent neurological damage. Early signs of meningitis may include high fever, headache, stiff neck, nausea or vomiting, photophobia, somnolence, confusion, ear pain and ear infection. Young children with meningitis can be sleepy, cranky and eat less.

• Diagnose and treat middle ear infections promptly. In some of the cases reported to FDA, patients with meningitis had shown signs of otitis media prior to the implant surgery or before the meningitis developed. According to the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients.

• Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants.

Additional Information:

CDC Website. Use of Meningitis Vaccine in Persons with Cochlear Implants: FACT SHEET for Healthcare Professionals. June 4, 2007.
http://www.cdc.gov/Vaccines/vpd-vac/mening/cochlear/dis-cochlear-faq-hcp.htm


Warning on Unapproved Antitussives Containing Hydrocodone

FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved.

Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been shown safe and effective for children under six, and yet some of these unapproved products have dosing instructions for children as young as two.

Also, FDA has received reports of medication errors associated with changes in the formulation of unapproved hydrocodone products, as well as name confusion between approved and unapproved ones.

There are seven FDA-approved antitussives that contain hydrocodone, and a variety of other approved cough suppressants without it. Providers should be certain that the antitussives they recommend to their patients are FDA-approved.

Additional Information:

FDA MedWatch Safety Alert. Hydrocodone in Unapproved Prescription Products. September 28, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152678.htm


Caution on Viracept in Children and Pregnant Women

Pfizer is advising healthcare professionals to avoid treating certain children and pregnant women with the antiretroviral drug Viracept (nelfinavir mesylate).

The company says that patients taking Viracept have the potential to be exposed to an impurity called ethyl methanesulfonate (EMS). EMS is formed during the drug manufacturing process and it is a potential human carcinogen.

Pfizer is refining the manufacturing process to further limit the amount of EMS in Viracept. In the meantime, FDA and Pfizer have agreed that the drug can continue to be used in patients where the benefits outweigh the potential risks. The company has also issued guidelines for treating children and pregnant women during this interim period.

The guidelines state that until further notice, children who are starting HIV treatment should not be given Viracept. However, children who are stable on regimens that contain Viracept may continue to receive the drug because the benefits are considered to outweigh the risks in these cases.

The guidelines also state that pregnant women starting antiretroviral therapy should not be given Viracept at this time. Pregnant women who are currently receiving Viracept should be switched to an alternative antiretroviral therapy, if possible. But if a pregnant patient has no alternative treatment options, the benefits of continuing to use Viracept are considered to outweigh the risks.

Additional Information:

FDA MedWatch Safety Alert. Viracept (nelfinavir mesylate). September 10, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152969.htm


Drug Safety Newsletter now Available

FDA is announcing a new quarterly publication for healthcare professionals called the Drug Safety Newsletter.

Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The new Drug Safety Newsletter is designed to keep the medical community - including physicians, dentists, nurses and pharmacists - up to date on important safety findings derived from these reports and other sources of information.

We hope the Drug Safety Newsletter helps you in making decisions about the drugs you use in your practice, and that it encourages you to report adverse events. You can get the newsletter and subscribe, free of charge, by going to the link below.

Additional Information:

Drug Safety Newsletter Home Page.
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/default.htm



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