Arizona Medical Malpractice Lawyer Blog

According to the FDA they have received reports of children experiencing premature puberty after coming in contact to the Evamist through skin contact with women using the spray.
The FDA warns that patients should take precautions to avoid unintentionally exposing children Evamist by wearing long sleeves to cover where they applied the Evamis.
If you experience an adverse event related to Evamist, or any other medication, you should report this to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Online: www.fda.gov/MedWatch/report.htm
• 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 complete details on this, go to:

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Cubicin (IV antibacterial drug) Associated with Eosinophilic Pneumonia (7.29.10)
The FDA recently reported the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug used to treat serious skin infections and bloodstream infections. Although rare, Eosinophilic pneumonia is a serious condition where a type of white blood cell (eosinophil) fills the lungs. Fever, shortness of breath, cough, and compromised breathing are some of the symptoms. If not timely treated, Eosinophilic pneumonia can progress to respiratory failure and death.
For further information, go to: Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

The FDA advisory panel recently narrowly recommended approval for Medtronic's new spine stabilization device, Amplify. According to the FDA, there was insufficient data to establish that the benefits outweighed the risks. One of those risk includes cancer. This Panel's recommendation is non-binding and is still subject to final approval by FDA.

FDA Panel Split on Medtronic Spine Device

According to researchers at the University of Texas Southwestern Medical Center, pregnant women that are positive for antithyroid peroxidase antibodies are three times more likely to experience placental abruption. The study data are not considered reliable, so further data is required to establish this link. Pregnancy Outcomes in Women With Thyroid Peroxidase Antibodies

According to recent study data cricoid pressure compromises laryngoscopic view, reduces bag-valve-mask ventilation efficiency, and does not prevent aspiration (Ann Emerg Med 2007; 50:653). These findings bring into question the long-standing belief that cricoid pressure during intubation is necessary to protect the pulmonary tree from aspiration of vomitus.
Harris T et al. Cricoid pressure and laryngeal manipulation in 402 pre-hospital emergency anaesthetics: Essential safety measure or a hindrance to rapid safe intubation? Resuscitation 2010 Jul; 81:810.

According to a recent study reported by BMJ overweight and obese women are more likely to encounter preterm delivery.
Nearly 1 million women were examined to determine the effects of maternal weight on pregnancy outcomes. Data indicate that overweight and obese women have a significantly higher likelihood than normal-weight women to deliver singletons spontaneously before 33 weeks' gestation. Additionally, there was an increased risk of induced deliveries before 37 weeks' gestation.

Overweight and obesity in mothers and risk of preterm birth and low birth weight infants: systematic review and meta-analyses

BMJ 2010;341:c3428

The FDA is conducting a review of a class of drugs (ARBs) commonly used to control blood pressure. This comes after a recent study demonstrated an increased risk of cancer associated with patients taking ARBs.

For additional information, go to: FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer

The FDA has issued a warning about specific lots of Advair Diskus inhalers that were stolen from a distribution warehouse in 2009 and have since turned up in some pharmacies. According to the FDA, the safety and effectiveness of the stolen inhalers cannot be assured so they should not be used.

The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

• Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
• Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)

If you have these lot numbers immediately stop using them and contact GlaxoSmithKline's Customer Response Center at 888-825-5249. You should then follow up obtaining a replacement inhaler from your physician. For additional information, go to: Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

According to the FDA Arava has been associated with severe liver injury. As such, the new Boxed Warning will now note this. Data show that 49 patients suffered severe liver injury. Of those, 14 resulted in death.
The new Boxed Warning will state:

Patients with pre-existing liver disease should not receive leflunomide.

Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.

Caution should be used in patients who are taking other drugs that can cause liver injury.

Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.

If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide - leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.

For additional information, go to:

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

Que She is sold as a herbal weight-loss supplement and contains fenfluramine, a drug that was withdrawn from the market because it caused heart valve damage. In addition to fenfluramine, Que She also contains propranolol (beta blocker), sibutramine (weight-loss drug), and ephedrine (stimulant). Propranolol is known to cause serious complications with asthmatics. Whereas sibutramine and ephedrine may cause cardiac complications.

According to the FDA, those taking Que She should stop and seek advice from a healthcare professional.

For further information, go to: FDA NEWS RELEASE

The FDA has issued a warning regarding the off-label use of Qualaquin for nighttime cramps because of continued reports of hemorrhaging due to thrombocytopenia and hemolytic-uremic syndrome which may result in permanent kidney

damage or death.

To report adverse reactions to Qualaquin or any other medications, contact the FDA's MedWatch Safety Information and Adverse Event Reporting Program at:

• Online:
FDA Med Watch
• Phone:
• 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 further information on Qualaquin, go to: Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

According to data from recent studies, CT scans may cause cancer in patients decades later. The concern is ever increasing because CT scans have increased by over 300% since 1993. Moreover, data demonstrate that CT scans vary dramatically depending on the procedure and the CT's settings. Many CTs provide improperly high amounts of ionizing radiation which is known to cause cancer. According to Amy Berrington de Gonzalez, researcher at the National Cancer Institute, a chest CT scan on a baby increases the baby's chance of developing radiation induced cancer to 1 in 200 chance.

For more information, go to: CT Scan Radiation May Cause Cancer Decades Later, Study Finds

Recent data from a nationwide, population-based study indicate that UTIs during pregnancy are not associated with increased risk of low birth weight (LBW) or small for gestational age (SGA) babies.

Acta Obstet Gynecol Scand. 2010 Jul;89(7):882-8.

These devices were manufactured from July 31, 2002 to September 19, 2007.
For complete information, including a link to the FDA Class I Recall Notice, go to: LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

For over a decade thiazolidinediones (TZDs) have been used for glycemic control for diabetic patients. During that time studies and clinical findings demonstrated that TZDs resulted in adverse cardiovascular events. Now additional studies point to increased risks of stroke, AMI (acute myocardial infarct), heart failure and death.
It is hoped that in light of these findings the FDA will reconsider the continued marketing of rosiglitazone.

More Bad News for Rosiglitazone

This deserves a drink: according to the University of Missouri moderate patients who suffered heart attacks (Myocardial Infarct) and drank moderately at the time of their MI experienced less adverse effects and better physical functioning than those who had quit consuming alcohol.

Comparison of Outcomes Among Moderate Alcohol Drinkers Before Acute Myocardial Infarction to Effect of Continued Versus Discontinuing Alcohol Intake After the Infarct

According to CNN, a Missouri VA hospital possibly exposed more than 1,800 veterans to viruses such as hepatitis and HIV. More than 1,800 letters were mailed out to veterans alerting them to the possibility that they could contract hepatitis B, C, or HIV if they visited the hospital for dental work.

CNN

For additional information, go to: VA hospital may have infected 1,800 veterans with HIV