Research Finds Female Lipitor Users Have Increased Risk of Diabetes

Three studies have determined women who take the cholesterol-lowering drug Lipitor have an increased risk of developing Type 2 Diabetes. In one study published by The Archives of Internal Medicine, the risk for older women was as high as 48 percent compared to women who do not take Lipitor.

As a result of the new research, the Food and Drug Administration issued a health warning in January 2012 requiring the labels of Lipitor and other statins to include the increased risk for diabetes.

“The announcement, medication label change and health advisory by the FDA were long overdue and have brought this important public health issue to light,” wrote Dr. Eric J. Topol, a professor of genomics at the Scripps Research Institute, in a New York Times article.

Lipitor works by preventing an enzyme in the liver from creating low density lipids (LDLs), a type of cholesterol that blocks the arteries. The drug essentially blocks the production of this cholesterol thereby reducing the user’s cholesterol level and risk of heart disease.

The attorneys at the Simmons Firm are currently investigating the legal rights of those who develop diabetes after taking Lipitor.

For more information about the research surrounding Lipitor and diabetes, click here. Comments (0)

Expert Testifies DePuy's Metal-on-Metal Hip Implant Has High Failure Rate

Dr. John A. Baron, a professor at Geisel School of Medicine at Dartmouth, testified Monday that the DePuy ASR metal-on-metal hip implants had a 22 percent failure rate within five years. He based his opinion on studies from Sweden, Australia and the United Kingdom, according to a LAW360 article about the trial.

He told the jury that this number is “striking” and “extraordinarily high” since the average rate of failure for hip implants is around 4 percent at five years.

The case is the first of thousands in the nation to go to trial. It alleges that Johnson & Johnson failed to warn consumers and their doctors about the dangers associated with the DePuy metal-on-metal hip replacements. Within five years, the implant has failed thousands of patients causing pain, swelling and problem walking.

More serious problems related to the medical device’s failure include:

• Metal poisoning from microscopic particles released by wear on the implant
• Loosening caused when the implant does not stay attached to the bone
• Fracture(s) where the bone around the implant may have broken
• Dislocation caused when the two parts of the implant that move against each other becoming misaligned

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntary recall of its ASR hip implant devices in 2010. For more information about the recalls and the legal rights of patients, click here. Comments (0)

The FDA’s Role in Dealing with Drug Shortages

When Ameridose, the company linked to the recent meningitis outbreaks and production of contaminated steroid injections closed its doors for the remainder of the year, many people worried about drug shortages. Since then, the FDA has been working to offset the drug shortages produced by the closing of Ameridose.

The FDA sees its role in dealing with drug shortages as a high priority, understanding that these medications are needed by people to stay healthy and treat illnesses. The administration reports the number of medications in short supply was 251 in 2011. In 2012, the FDA worked with drug manufacturers to deal with shortages of 145 drugs.

In regards to the closing of Ameridose and its lack of drug production, the FDA is taking the following steps:

• The administration is working with manufacturers of drugs previously supplied by Ameridose, requesting them to increase production if they are able.
• The FDA is offering assistance to any drug manufacturers that are having production problems to ensure production is of safe and high quality.
• The FDA will continue to expedite the reviews of any pending applications that may assist with addressing drug shortages.
• The FDA is identifying additional manufacturers willing to produce drugs in short supply.
• If needed, the FDA will explore overseas companies that are willing and able to import medications to aid in the shortage.

In an FDA Voice post by Margaret A. Hamburg, M.D. and Commissioner of the FDA, Hamburg writes, “[w]e at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.”

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Continued Meningitis Cases Have Doctors Baffled

More than one month ago, fungal meningitis cases began appearing from the use of tainted steroid injections, resulting in a total of 37 deaths. The 42-day risk period for contracting fungal meningitis from these injections ended on November 7, but new cases of meningitis and infections continue to develop. Some of these new cases appear to be in individuals previously treated and sent home.

Since December 12, the Centers for Disease Control have reported 39 new spinal infections that are not meningitis, five new cases that are meningitis, and three new joint infections. 

“Here’s the perplexing issue,” said Dr. Tom Chiller, deputy chief of the Centers of Disease Control and Prevention’s mycotic disease branch, in an ABC News article. “Why are we getting people that early on who are presenting with rip-roaring meningitis, but now, they’re presenting 100 days later with focal infections only? Why the difference? We don’t know.”

Previously, an investigation by the FDA revealed that about one-quarter of the steroid vials in an NECC bin contained a “greenish black foreign matter”, as disclosed in an FDA report released on October 26. This report also identified rooms where sterile products were produced that had mold or bacterial growth.

Approximately 14,000 people received injections that were tainted and produced by a New England Compounding Center in Massachusetts, which later recalled all of its products and shut down for the remainder of the year.

“We hope we’re nearing the end of this,” Chiller said.

Read the full ABC News article here: http://abcnews.go.com/Health/fungal-meningitis-cases-spinal-infections-baffle-doctors/story?id=17937366#.UNHNS6zqR4t 

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The Energy Drink Craze: Is It Safe?

Are energy drinks a hazard to our health? Recent news regarding a wrongful death lawsuit involving a 14-year-old girl who died after drinking two 24-ounce cans of Monster Energy within 24 hours suggests this may be a possibility. Should the Food and Drug Administration (FDA) step in and do more to regulate the use of energy drinks?

The New York Times reports a letter was released by the FDA on November 21 discussing the future plans of the administration regarding energy drink-related injuries and deaths. The letter states the FDA plans to “seek advice from outside experts to help determine whether energy drinks posed particular risks to teenagers or people with underlying health problems.”

Health Hazards Linked to Energy Drinks

Numbers show the amount of people visiting the emergency room for energy-drink related reasons has increased ten-fold since 2005. This year, the FDA reports 18 deaths related to the consumption of drinks such as 5-hour Energy and Monster Energy. The lack of awareness regarding the high volume of caffeine contained in the drinks could be a factor, especially in regards to heavy consumption.

Among the reports of injuries or deaths caused by energy drinks, which include 5-hour Energy, Monster Energy and Rockstar energy drinks, WebMD reports the following:

• Deaths due to heart attack or suicide linked to 5-hour Energy
• A miscarriage linked to 5-Hour Energy
• Convulsions, life-threatening fear, deafness and hemorrhage linked to Monster Energy
• Hospitalization due to irregular heartbeat, severe diarrhea, migraine, psychotic disorder, heart attack, and/or vomiting linked to Monster Energy
• Disability from irregular heartbeat or stroke linked to Rockstar Energy
• Hospitalization due to psychotic disorder, increased heart rate or loss of consciousness linked to Rockstar Energy drink

The FDA reports, however, that “there is no scientific literature that calls into question the safety of taurine and guarana, two ingredients often used in energy drinks” yet the AP reports the administration is now “studying energy drinks to see if they posed a risk when consumed by ‘vulnerable groups’ such as young people, or in excess,” but is not planning to take action against the energy drink manufacturers any time soon.

When consumed in moderation, energy drinks are as safe as consuming a few cups of coffee. It’s when heavy consumption comes into play that serious health hazards sometimes arise.

Explore more information on the most recent energy drink litigation and the link between energy drinks and serious health hazards from the Simmons Firm now.

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The Latest in Meningitis Outbreak News

The meningitis outbreaks that took place in October and November made headlines for much of the past month.  Following the death of 32 people from the outbreaks, the FDA discovered a link between the meningitis cases and contaminated medications, primarily injectable drugs manufactured by the company Ameridose.

Following the link to Ameridose, the company recalled all of its products, causing many hospitals to worry about a shortage of supply of these medications, which are commonly given as shots or intravenous drips during surgery. One of these drugs formerly produced by Ameridose, sodium bicarbonate, is used in emergency care to return the acidity in a patient’s blood to normal levels. Another of the primary Ameridose drugs is succinylcholine, a medication used by anesthesiologists during surgery to temporarily paralyze neuromuscular functioning.

Soon after the recall of the drugs linked to the meningitis deaths, Ameridose announced the lay-off of hundreds of employees. This was caused by an on-site investigation by the FDA that found the company needed to make vast improvements to its sterility testing process. 

By mid-November, the company had decided to remain closed for the rest of the year while the investigations by state and federal authorities continue. The reopening of the facility depends on whether further unsanitary conditions and questionable disinfectant practices are found.

The issue of drug shortages remains a concern, as the American Hospital Association declares in a Reuters article that “82 percent of hospitals said patients had experienced delays in treatment due to drug shortages”, with 50 percent of those hospitals saying the shortages prevented them from providing the proper treatment to patients in need. 

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Pradaxa and Chantix Account for the Most Drug Complaints to the FDA

The October 2012 QuarterWatch report from the Institute for Safe Medication Practices details the number of drug complaints received by the FDA over the past four years. Prescription medication complaints issued to the FDA have risen 90 percent between 2008 and 2012. This increase amounts to an additional 27,290 cases per quarter¹.

“All the increase was attributable to reports from drug manufacturers rather than cases submitted directly to the FDA,” the report claims¹.

Prescription medications Pradaxa and Chantix are said to make up 37 percent of the 90 percent increase of serious adverse drug event reports1. The FDA has been investigating Pradaxa and its dangerous side effects since December 7, 2011. The FDA has received hundreds of reports of deaths among Pradaxa users for the year 2011, more than any other prescription medication in that same year.

Pradaxa is a blood-thinning drug meant to treat atrial fibrillation and reduce risk of stroke, pulmonary embolism and other blood-clotting conditions. Contrary to this, Pradaxa has been linked to complicated and often serious health problems such as internal bleeding, heart failure and death.

Other Pradaxa side effects may include:

• Serious allergic reaction
• Chest pain
• Swelling of the face or tongue
• Trouble breathing or wheezing
• Feeling dizzy or faint
• Indigestion
• Stomach burning or pain
• Nausea

Pradaxa has been on the market since October 2010 and has been the center of FDA investigations for reports of association with serious injuries. Learn more about Pradaxa side effects, FDA warnings, and issues associated with the blood-thinning drug today.

_Source: 
¹ Institute for Safe Medication Practices. QuarterWatch: Monitoring FDA MedWatch Reports. Why Reports of Serious Adverse Drug Events Continue to Grow. October 3, 2012. PDF.http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf

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