Recent 'Product Safety'

Avandia Safety – review by FDA

Sunday, July 11th, 2010

Previously on the Important Lawsuits website we reported that lawsuits regarding the diabetes drug Avandia were being filed by consumers.  Now there is new information from the FDA regarding the safety of Avandia.

FDA scientists have reviewed information provided by the drug’s maker GlaxoSmithKline in anticipation of a meeting being held starting on Tuesday.  A panel of physicians will be meeting and voting on a wide range of recommendations regarding Avandia including:

  • Adding warning labels in addition to the ones already included with the product,
  • Putting a limit on what doctors will be able to prescribe the drug, or even
  • Pulling the drug from the market altogether.

The panel of doctors who will be voting on the recommendations are outside experts.  The FDA is engaging these outside experts because there has been some disagreement among FDA scientists regarding Avandia.  Dr. Janet Woodcock, head of the FDA’s drug center, stated that there was not “complete unanimity within the FDA” regarding interpretation of data on this drug.

In June of 2010 there was an article published that suggested Avandia is more likely to cause strokes and heart related deaths than a rival drug, Actos.  However, some experts will say that people who take Avandia (those suffering from Type 2 Diabetes) have an increased risk for heart problems.

It will be interesting to see what the FDA does after hearing the recommendation from this outside panel of experts.  The FDA is not required to follow their suggestions.

UPDATE 7/15/2010:  The panel convenied by the FDA has voted to allow Avandia to remain on the market.  However, the panel stated that stronger “black box” warnings were needed.  Read more about this on the Wall Street Journal’s website by clicking the link here.

Rotarix Vaccine Potential Issues and Problems

Wednesday, April 7th, 2010

In March of 2010 the Food and Drug Administration (FDA) notified health care professionals that it was the recommendation of the FDA to temporarily suspend the use of the Rotarix vaccine Rotarix is a vaccine given to children to prevent rotavirus disease. 

The FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix.  Right now there is no known evidence that the PCV1 virus causes disease in humans nor that there is a safety risk with the vaccine.  The recommendation to suspend the use of the Rotarix virus was a precaution by the FDA while it investigates the situation.  It is expected that the FDA will make further recommendations regarding the use of this vaccine in the next four to six weeks.

Rotavirus is a virus that causes severe diarrhea and dehydration in young infants.  There are two vaccines for rotavirus available currently in the US – Rotarix and RotaTeq.  If your child received his or her first vaccine of Rotarix the Centers for Disease Control (CDC) have indicated that the vaccine series can be completed using RotaTeq (two additional doses).

Since available evidence supports the safety of Rotarix the FDA has stated that no medical follow up is necessary for patients who have received this vaccine.

Can Zocor, Vytorin and Simcor cause serious muscle damage in patients?

Saturday, March 20th, 2010

Zocor, the popular cholesterol lowering drug manufactured by Merck & Co. already carries warnings about muscle pain and weakness as a serious side effect of the drug.  However, on Friday the Food and Drug Administration (FDA) issued its own warnings to health care providers and patients about a serious risk of muscle injury and kidney damage for some patients who take Zocor.

Zocor is the brand name of the drug simvastatin.  It is found as a component in the cholesterol lowering drug Vytorin (manufactured by Merck) and Simcor (manufactured by Abbott Laboratories). 

The warning issued by the FDA is for patients who take the highest approved dose of the medication (which is 80 milligrams).  Patients who take lower doses of the drug Zocor and possibly other drugs in this class (known as statins) appear to be at a lower risk for such injury.

The potentially deadly side effect that the FDA is warning about is known as rhabdomyolysis.  This is a form of muscle damage that can lead to kidney damage and possibly kidney failure and even death.  The FDA based their warning on information gathered from clinical trials and studies, reports of side effects by users, and prescription data.

Statins are a type of drug that is taken to reduce the body’s levels of LDL cholesterol by limiting the amount of cholesterol that can be produced in the body.  Other drugs that fall under the class of statins include the popular medications Lipitor (manufactured by Pfizer) and Crestor (manufactured by Astra Zeneca).

Is there a link between Fosamax and femur fractures?

Tuesday, March 9th, 2010

Can Fosamax (the popular osteoporosis drug) cause more harm than good?  That’s a question viewers of ABC’s Good Morning America are asking themselves after watching a report on the show this morning.  A new study set to be released this week says that the drug Fosamax, designed to help strengthen bones, could cause a weakening of the bones as a side effect when taken for an extended period of time (meaning over the course of more than five years).

In 2008 the FDA contacted the manufacturer of the drug about reports of femur fractures happening in women who took this popular drug.  Merck (the maker of Fosamax) has added femur fractures as a possible side effect in the literature included in the patient information in the drug package.

Fosamax is part of a class of drugs known as bisphosphonates.  These drugs have been proven to help prevent hip and spine fractures in many patients.  Doctors do agree that the possible dangers of fractures of the hip and spine that can occur in patients with osteoporosis are a problem and the chance of these fractures and the associated side effects of them (including death) must be weighed against any potential side effects of the drugs.  While there is no conclusive research on the length of time a patient can safely take this class of drugs, doctors recommend that patients not take it for more than five years.

US CPSC declares Zhu Zhu pets safe

Tuesday, December 8th, 2009

Previously in this blog we reported that there were concerns about the safety of Zhu Zhu pets.  The US Consumer Product Safety Commission has reported that the toy is not out of compliance with the mandatory US toy standards.  While the CPSC stated they will still do their own independent testing, they are confident that the toy is safe and does not violate the antimony standard for all toys in the US.

The consumer group GoodGuide who initially brought up concerns about the safety of the toy released a statement Monday that clarified its testing methods and apologized for comparing their results to federal  standards.  In the statement they report that after issuing the warning about Zhu Zhu pets they have since learned that the methodology they used for testing Mister Squiggles (the toy in question) was not the same as the methodology used by the federal government.

Zhu Zhu pets claimed unsafe by GoodGuide

Sunday, December 6th, 2009

CNN’s website, CNN.Com , is reporting that a consumer group is claiming that Zhu Zhu pets are dangerous for children.  The makers of Zhu Zhu Pets, Cepia LLC, has denied these claims.

The consumer group GoodGuide has stated that the light brown version of the popular hamster toy named Mister Squiggles has unsafe levels of the chemical antimony.  The web site for GoodGuide (www.goodguide.com) reports that this chemical, along with tin, was found during their testing of this product.  This web site states that the chemical antimony has been linked to such medical problems as cancer, lung and heart disorders.   

The testing done by GoodGuide showed that the chemical antimony was found to be 90 parts per million in Mister Squiggles, while the industry standard for this chemical is 60 parts per million.

Cepia CEO Russ Hornsby defends the safety of the toy and in a written statement assures customers that the company performs rigorous safety testing on all their toys.  He further states that the results of all these tests show that Zhu Zhu pets and all their products are in compliance with government and industry safety standards.

Zhu Zhu pets are one of this season’s hottest toys.  They simulate a real hamster, giving children the opportunity to have a pet without all the mess and stink associated with real hamsters.