Arizona Medical Malpractice Lawyer Blog

According to the FDA patients in the long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), may be at an increased risk for developing prostate cancer. The FDA has yet to confirm this increased risk pending its review of available data from the study. At this time, however, the FDA has notified professionals of the possible risk and has recommended that they follow current guidelines for prostate cancer screening. Patients taking Stalevo should continue unless directed otherwise by their healthcare professional.
For more information go to: Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

Despite government warnings regarding the risks of routine CT scans used to screen patients for colon cancer, the FDA recently met with experts to discuss ways to protect patients from unnecessary radiation exposure. It is estimated that nearly 14,000 people die each year from radiation-induced cancer.
For more information go to: Scientists Say F.D.A. Ignored Radiation Warnings

Before December 2008 when the FDA began requiring a black box warning on OsmoPrep, many lawsuits were filed concerning the risk of kidney damage from the product's use. Recently, a number of lawsuits have been filed claiming that kidney damage occurred before the black box warning was issued. Included in many of these lawsuits, are the gastroenterologist and the endoscopy center.
The black box warning indicates that older patients are at a greater risk of hypovolemia, bowel obstruction, active colitis, and kidney disease. It also states that patients taking diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and in some cases, NSAIDs are at an increased risk level.
Since 2005, OsmoPrep has been associated with acute kidney injury. Between 2006 and December 2008, the FDA received 20 reports of kidney damage allegedly caused by OsmoPrep.
Is There a Rising Tide of Bowel Prep Lawsuits?

According to the FDA DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. Although PCV1 is not known to cause disease in humans, the is not evidence that this presents a safety risk.
There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. If a child has received one dose of Rotarix, CDC advises that clinicians complete the series with RotaTeq for the next two doses.
For the complete MedWatch 2010 Safety summary, including a link to the Update statement from FDA, go to:
Rotarix Vaccine: Update to Clinicians and Public Health Professionals

Specific lots of Cleviprex (i.e., antihypertensive injectable), manufactured by The Medicines Company, were recalled recently because they possibly contained inert stainless steel particles. Although no reports of adverse events have been reported, medical providers are being warned by the FDA to remove the suspect vials from their stock and to return them to the manufacuturer.

Boston Scientific has ceased shipment and began recalling all of its implantable cardioverter defibrillators as well as cardiac resynchronization therapy defibrillators (CRT-Ds) that are the supply chain and not already implanted in a patient.
According to the FDA these devices should not be implanted until the FDA completes its review and approves changes made by Boston Scientfic. At this time, there is no evidence warranting the explanting of these devices.
The entire safety summary can be viewed at:
Boston Scientific Implantable Cardioverter Defibrillators: Recall

According to the FDA's review of data from a large clinical trial and other sources, patients taking the highest approved dose of Zocor (80mg) are at an increased risk of muscle injury. Although not yet confirmed, it is possible that this risk is associated with simvastatin and as well as other drugs in the "statin" class. The FDA will continue to investigate this possible link and report its findings in the future.
To view the complete MedWatch 2010 Safety summary go to
Zocor (simvastatin): increased risk of muscle injury with high doses

Bisphosphonates (Actonel,Boniva, Fopsamax) have been linked to higher risk of hip fractures after long-term (i.e., more than five years) use. Studies show that the drugs can cause the bones to become brittle.

The FDA is reviewing these new findings and should publish its recommendations in the near future.
Long-term use of osteoporosis drugs linked to hip breaks

The One Touch Sure Step test strips may not provide accurate glucose results if levels are higher than 400 mg. They were distributed between August 2009 and January 2010.
It is encouraged for patients to contact their physician if levels are over 400 mg.
OneTouch SureStep Test Strips (LifeScan): Recall

A recent study found that three recommended treatments (i.e., [1] reducing blood pressure, [2] rasing HDL cholesterol and lowering triglycerides, and [3] modulating sharp upswings in glucose post meals) for Type 2 diabetics could increase rather than reduce their risk of heart attacks. Additionally, these regimens resulted in severe side effects.
Diabetes Heart Treatments May Cause Harm

There is danger during the procedure the tip may break and fragments would cause blockages to brain and organs. There is a possibility of death, stroke or heart attack. The devices were distributed from October 2006 through December 2009
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall

Prescription medical devises utilized to treat adult patients and pediatric patients with kidney failure have been associated with at least one death.
It is recommended to increase monitoring on children and adults that are not able to communicate verbally.
Contact the physician immediately and perform manual drain if sings of llPV.
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

FDA is investigating MicroMed Cardiovascular for failing to report the death of a 4-year-old patient. MicroMed has denied that its pediatric heart pump had anything to do with the child's death. According to MicroMed the device was working properly
Houston maker of heart pump under fire

Certain fish oils contain chemicals banned in 1979. Some of the tested supplements exceed California's daily limit for PCB's. A limit has not been set for risk of birth defects.
Tested Products

• Nature made cod live roil and odorless fish oil; manufacturer pharmavite LLC in Northridge


• Twinlab Norwegian cod liver oil and emulsified Norwegian cod liver oil; manufactured in American Fork, Utah.


• Now Foods shark liver oil, double strength cod liver oil and salmon oil; manufactured in n Bloomingdale,III.


• Solgar 100 percent pure Norwegian shark liver oil complex and Norwegian cod liver oil; manufactured in Leonia, N. J.


• GNC liquid Norwegian cod liver oil; manufactured in Pittsburgh.
  Lawsuit claims PCBs found in 10 fish oil supplements; product labeling sought,