Arizona Medical Malpractice Lawyer Blog

In addition to the previous recall the Nihon Kohden (NK) and GE Responder models are also affected. Additionally, on February 24, 2010 Cardiac Science issued a software upgrade for the devices' (Powerheart automatic external defibrillators, Models 9390A and 9390E) self tests and is planning on a similar software upgrade for other affected devices. FDA recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.

For the complete MedWatch 2010 Safety alert along with links to the original recall, go to: Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall

Amiodarone is used to treat significant or severe heart arrhythmias. Unfortunately it can result in serious pulmonary toxicity in 5 to 18 percent of patients. Symptoms of pulmonary toxicity include, chronic dry cough, acute or sudden onset of chest pain in or around the lungs, shortness of breath, bronchospasms, fever or an overall feeling of illness.

Unfortunately pulmonary toxicity is insidious and once diagnosed there is little, other than time, that can effectively reverse the toxicity because Amiodarone accumulates in the lungs and other organs and is not excreted in the liver or kidneys like most drugs. As such, it takes days or weeks before the drug dissipates from the body.

The most effective prevention for Amiodarone-induced pulmonary toxicity is to undergo a lung function test as well as a chest x-ray before taking Amiodarone and then continuing these tests periodically throughout the course of treatment.

According to the FDA the Physico-Control Lifepak 15 monitor/defibrillator manufactured between March 26, 2009 and December 15, 2009 is being recalled because of the potential for potential unexpected power issues, such as powering off then on unexpectedly, powering off unexpectedly or remaining on without the ability to be turned off.
Adverse events related to the use of the Physico-Control Lifepak 15 Monitor/Defibrillator should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Online: FDA.gov/MedWatch/report.
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms2" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

A Boxed Warning is being added to the label for propylthiouracil, to include information regarding reports of severe liver injury and acute liver failure in adult and pediatric patients using propylthiouracil.
The FDA is encouraging patients and physicians to report adverse events or side effects related to the use of propylthiouracil to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Online. FDA.gov/MedWatch/report.
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178
For the complete MedWatch 2010 Safety summary go to:
Propylthiouracil

Federal Law requires hospitals to report disciplined physicians to the National Practioner Data Bank. Unfortunately, for nearly twenty years many hospitals have failed to comply with this law. The Data Bank was developed to protect the public from incompetent physicians who move to other hospitals or states and fail to disclose their disciplinary history. Hospitals access the Data Bank before hiring a physician to confirm their history and disciplinary history, allowing them to access one centralized database as opposed to contacting each state's medical board. According to Public Citizen 49 percent of hospitals failed to report any physician disciplinary actions to the Data Bank from 1990 through 2007.
Despite law, many U.S. hospitals aren't reporting disciplinary action to a national database

Once again, the FDA is warning the public about an increased risk of neural tube and craniofacial defects occurring in infants whose mothers take Depacon (valproate sodium injection), Depakene (valproic acid), Stavzor (valproic acid), and Depakote (divalproex sodium) during pregnancy. Although patients taking folic acid before becoming pregnant and during their first semester can decrease the risk of neural tube defects, healthcare professionals should advise patients of childbearing age to consider alternative therapies.

FDA warns of birth defects with valproate sodium, valproic acid, and divalproex sodium

FDA has received reports of altered kidney function, such as acute renal failure and renal insufficiency, in patients treated with Byetta. Physicians should warn patients taking Byetta to look for signs and symptoms of altered kidney function (e.g., changes in urination, unexplained swelling, increases in blood pressure, lethargy, or dull ache in the mid to lower back). Should the patient's kidney function decline while taking Byetta, then the physician should consider discontinuing Byetta.

FDA Patient Safety News: USFoodandDrugAdmin

Adolescents taking Zyprexa are at an increased risk of weight gain and increased total cholesterol, LDL cholesterol, triglycerides, prolactin, and hepatic transaminase levels. Additionally, adolescents may experience sedation, more so than adults.

FDA Patient Safety News: USFoodandDrugAdmin

A recent study by Shadid Beheshti University of Medical Sciences in Tehran, Iran found that the use of nonsteroidal anti-inflamatory drugs does not increase the incidence of false-negative results as previously believed. Accuracy of rapid urease test in diagnosing Helicobacter pylori infection in patients using NSAIDs

Data from a nationwide, population-based study indicates that there is an increased risk of adverse pregnancy outcomes (i.e., low birthweight (LBW), preterm birth, infants born small for gestational age, caesarean section (CS) and pre-eclampsia) for women suffering migraines. Although the causative link is unclear, perhaps further studies will address this and lead to preventive measures to reduce adverse pregnancy outcomes with migraine sufferers. Increased risk of adverse pregnancy outcomes for women with migraines: A nationwide population-based study

According to the FDA, it will no longer allow third-parties to participate in the approval process of radiotherapy devices (e.g., CT scanners). Instead, the FDA will head up the approval process which is expected to be more aggressive. This comes after the FDA discovered that many of the radiotherapy device problems could be reduced by builiding in additional safeguards to prevent radiation overdoses.
F.D.A. Toughens Process for Radiation Equipment

According to meta-analysis data published by British Medical Journal (BMJ) Online, treatment aimed at controlling blood glucose levels reduces the risk of some perinatal or neonatal complications, such as shoulder dystocia and macrosomic babies (i.e., babies whose birth weight is above the 90th percentile).

With this new data, it might very well support screening for gestational diabetes and early, aggressive treatment.
Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis

Scottsdale Physician, Stewart C. Mann, recently pleaded guilty to billing Medicare $480,000 for excising malignant lesions that he never performed. Dr. Mann faces up to ten years in prison and/or a $250,000 find. He is sentencing hearing is set for June 21, 2010.

Associated Press
Scottsdale Doc pleads guilty to fraud

Data from the Nurse's Health Study demonstrate almost a 50% reduction in the risk of breast cancer death and metastasis for women who have completed treatment for early-stage breast cancer and who take aspirin.

Should these findings be confirmed in other clinical trials, aspirin may become a simple, low-cost, and relatively safe medication to help women with breast cancer survive longer and face a significant reduction in metastasis.

Although these are promising findings, the study's authors made it clear that women undergoing cancer treatment must avoid aspirin because of the potential for adverse reactions.

Journal of Clinical Oncology
Aspirin Use Linked to Reduced Risk of Death, Metastasis in Patients With Breast Cancer

Healthcare professionals and consumers were notified by the FDA about serious medication errors concerning Maalox. Maalox products contain bismuth subsalicylate which can cause bleeding. Individuals with gastrointestinal ulcers or people taking certain medications should avoid Maalox. Maalox Total Relief and Maalox Liquid Products: Medication Use Errors

The system that supplies power to blood pumps my shut down without warning. This may cause death or serious injuries. They were distributed between May 2003 and December 2009
Abiomed AB5000 Circulatory Support System: Class I Recall

Boxed warnings added to Plavix. Doctors advised by FDA to consider alternative doses or alternative medications for poor metabolizers. Doctors and patients should discuss whether the patient should be tested prior to taking Plavix.
Effient is recommended to patients undergoing open-heart surgery. This alternative drug also has boxed warning for bleeding risks.
2nd UPDATE: FDA Adds Boxed Warning To Plavix On Effectiveness

Healthcare professionals were notified of the Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. The devises are used to treat pediatric and adult patients with kidney failure. Serious injuries and at least one death have been reported.
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall