Arizona Medical Malpractice Lawyer Blog

To view a complete list of drugs requiring revised labels during January 2011,
January 2011 Safety Label Changes

The FDA is requiring a label change to the Pregnancy section of all antipsychotic drugs to note potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal in newborns whose mothers received these drugs during the third trimester of pregnancy.
Symptoms may include agitation, increased or decreased muscle tone, tremors, sleepiness, significant difficulty breathing, as well as difficulty feeding.

To report an adverse event from antipsychotics:

By providing screening and treatment for common vaginal infections during antenatal care, preterm births were reduced significantly. Reducing the rate of preterm birth through a simple antenatal screen-and-treat programme: a retrospective cohort study.

The cancer drug, Avastin, has proven to be more effective than laser surgery in treating premature infants who are born before their eyes are fully developed. According to the study, one injection of Avastin into the eyes was more effective than laser treatment.

STUDY SAYS ROCHE'S AVASTIN COULD PREVENT BLINDNESS IN PREMATURE BABIES

Data show that those consuming over 29 grams of grain fiber daily were 22% less like to succumb to any illness, particularly cardiovascular, infectious and respiratory. Interestingly, fiber from other sources did not result in the same benefits as grain fiber.

Fiber-Full Diet Lengthens Life

Primary source: Archives of Internal Medicine
Source reference:

Dietary Fiber Intake and Mortality in the NIH-AARP Diet and Health Study

Additional source: Archives of Internal Medicine
Source reference:

Do the Health Benefits of Dietary Fiber Extend Beyond Cardiovascular Disease?

The flavonoid, anthocyamin, found in berries can reduce the risk of Parkinson's by as much as 22%. Researchers found that the more berries consumed the smaller the risk of Parkinson's. AAN:

Berries Keep Parkinson's at Bay

Primary source: American Academy of Neurology
Source reference:
Gao X, et al "Habitual intake of dietary flavonoids and risk of Parkinson's disease" AAN 2011.

Recent data demonstrate that deliveries before 39 weeks have an increased risk of respiratory issues and other complications despite establishing fetal lung maturity before delivery. SMFM:

Early Delivery Risky Even for Mature Lungs

Primary source: Society for Maternal-Fetal Medicine
Source reference:
Fang Y, et al "Elective delivery with known fetal lung maturity prior to 39 weeks is still associated with increased neonatal morbidity" Am J Obstet Gynecol 2011; Abstract 58.

Nitrous oxide fell out of favor in the U.S. several decades ago and was replaced by epidurals (nerve block accomplished by injecting a anesthetic mix into the spinal fluid via the lumbar spine). Recently, however, there is a renewed interest in its use of controlling pain during delivery. Although it is effective in reducing pain, it does not eliminate pain and sensation like epidurals. Nevertheless, it is significantly less expensive and safer than epidurals. Nitrous Oxide for Labor Analgesia

Laughing Gas For Childbirth: Is It Safe?

Women who require induction of labor for their first delivery can shorten their labor by two or more hours by undergoing amniotomy early on, according to recent study data.

SMFM: Early Amniotomy Shortens Labor

Primary source: Society for Maternal-Fetal Medicine
Source reference:
Macones G, et al "The efficiency of early amniotomy in nulliparous labor induction: a randomized controlled trial" Am J Obstet & Gynecol 2011; 204: Abstract 6.

According to recent study data tPA administered within one hour of an ischemic stroke results in reduced mortality and intracranial hemorrhaging. Additional findings suggest that for every additional quarter-hour delay, there is an additional 5% increased risk of mortality and hemorrhaging. ASA: Earlier tPA in Hospital Saves Lives

Primary source: Circulation: Journal of the American Heart Association
Source reference:
Fonarow GC, et al "Timeliness of tissue plasminogen activator therapy in acute ischemic stroke: Patient characteristics, hospital factors, and outcomes associated with door-to-needle times within 60 minutes" Circulation 2011.

After opening a bottle of Dabigatran it begins to degrade quickly due to humidity in the air. Despite a desiccant (drying agent) built into the bottle cap, the drug will lose its effectiveness 30 days after opening. Use Dabigatran Within 30 Days of Opening

Makena is an injection that is given once a week starting as early as the 16th week of pregnancy but no later than the 21st week. According to study data, Makena resulted in more than a 30% reduction in preterm deliveries. FDA Press Release

Recent study data support utilizing Propanol (Inderal) to effectively and safely treat hemangiomas in infants. Because of its promising results, Inderal will likely replace steroid as the drug of choice for treating infants with hemangiomas. PCCD: Beta-Blocker Safe for Hemangiomas
Primary source: Pediatric and Congenital Cardiovascular Disease meeting

Source reference:
Thampan A, et al "Propanolol for infantile hemangiomas: safety and efficacy" PCCD Meeting 2011; Abstract F22.

Once again the FDA is warning about the cardiovascular risks associate with Avandia and adding an admonition that only patients already treating with Avandia or whose glucose cannot be adequately controlled with other anti-diabetic medications.

For further information, go to: Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

After instituting a quality-improvement program in ninety-five Michigan hospitals' ICUs departments patients had a nearly 25% decrease in mortality risks. Improved communications between providers, hand-washing policies, full barrier precautions and avoiding femoral insertion for catheters, were some of the quality processes resulting in the significant improvement of patient safety.

Primary source: BMJ
Source reference: Impact of a statewide intensive care unit quality improvement initiative on hospital mortality and length of stay: retrospective comparative analysis

Patients who received Avastin during their cancer treatment experienced nearly 50% increased risk of death depending on what type of chemotherapy was utilized in conjunction with Avastin.

Primary source: Journal of the American Medical Association
Source reference: Treatment-Related Mortality With Bevacizumab in Cancer Patients

Additional source: Journal of the American Medical Association
Source reference: Bevacizumab Treatment for Solid Tumors

Recent study data from Harvard Medical School show that elderly individuals who performed aerobic exercise (e.g., walking) at least three times a week exhibited increased hippocampus volume which in turn resulted in enhanced memory.

Primary source: Proceedings of the National Academy of Sciences
Source reference:

Exercise training increases size of hippocampus and improves memory