Consumers File Lawsuits Alleging Actos is Dangerous

As obesity rates rise in America, so too do health problems such as diabetes.  Type 2 diabetes, once very rarely seen in America, is now a common problem, and one in which we have a variety of medications to treat. One such treatment is Actos (pioglitazone) which is manufactured by Takeda Pharmaceuticals and distributed in America by Eli Lilly.

Approximately 20% of the diabetes medication today is Actos (pioglitazone.)  As one of the most commonly prescribed medications, this drug has earned Takeda Pharmaceuticals over $5 billion in sales per year.  However, it has also been linked to some severe problems over the years.

The Alleged Dangers of Actos 

Since its introduction to the market in 1999, some researchers have been wary. Over the years, many reports have emerged that paint a grim picture of the drug.  Study after study has linked Actos (pioglitazone) to the following:

• bladder cancer
• heart failure 
• liver failure
• and even bone fractures.  

Studies such as Kaiser Permanente's 2008 decade long meta study concluded that taking Actos for a year or longer increased the risk of bladder cancer among patients.  This damning study was no isolated report, though.  Similar studies have emerged to allegedly confirm these suspicions such as France's Medicines Agency's 2006 to 2009 study, leading to their classification that this drug was dangerous. 

After enough of these reports have emerged, and enough consumers complained about allegedly unusual side effects, the U.S. Food and Drug Administration (FDA) stepped in to issue a safety alert in June 2001 claiming there is as much as a 40% chance that taking Actos (pioglitazone) for a year or longer is related to developing bladder cancer.

Actos Litigation

To date, over 1,000 patients across America have lawyered up and filed lawsuits against Takeda Pharmaceuticals, alleging the manufacturer knew or should have known that this drug would cause bladder cancer.  These patients are claiming that their bladder cancer is a direct result of taking their prescribed Actos medication. 

If you have taken Actos and have similarly developed bladder cancer, you may be entitled to compensation for your Actos injury.  Call an experienced product liability attorney today to discuss your rights. 

FDA Recommends Lowering Women's Ambien (Zolpidem) Dosages to Prevent Risk of Injury

America is one of the most frenetic countries in the world, or so you would believe. Millions of Americans suffer the effects of insomnia every year.  With increased stress, poorer diets, and increased responsibilities, it's no secret that people are feeling sleep deprived.  In a National Sleep Foundation poll, approximately 48% of Americans reported experiencing insomnia, 22% of which experience insomnia on a nightly basis.  

To combat insomnia, there are a variety of treatments out there, including the use of sleep aids such as the popular drug, Ambien.  Over 16 million Americans currently take Ambien per year.  This popular drug is also known as zolpidem, a hypnotic sedative that helps consumers fall asleep and stay asleep for more restful sleep.  

The Dangers Associated With Ambien (zolpidem)

Ambien has become quite the controversial drug.  Ambien sleep aids have been linked to a variety of strange parasomnia sleep activities.  These strange behaviors have led both consumers and federal regulators such as the U.S. Food and Drug Administration (FDA) to question whether dosages should be changed to prevent these complications. 

The FDA recently published recommendations that women should lower their dosages of Ambien (zolpidem) by half.  This recommendation is intended to account for a slower absorption rate than their male counterparts.  Their studies concluded that women who had taken Ambien the night before could still have the drug active in their system 8 hours later and be a risk to others. 

Ambien has been identified as a risk factor for the following:

• sleep driving, including 700 reported driving accidents while "asleep" on Ambien
• sleep eating
• sleep walking
• death

A group of researchers at Scripps Health in San Diego identified that in 2010, hypnotic sleep aids like Ambien were the cause for nearly a half a million "excess deaths".  These researchers  found that sleep aid users were three times more likely to die than people who did not use sleep aids.

This evidence echoes a similar study in Sweden where researchers in 2009 found that frequent users of sleep aids were between 2 and 4.5 times more likely to die early depending upon their gender. 

If You Have Been Injured 

Over 70 million Americans take prescription sleep aids every year.  According to a growing body of evidence, Ambien (zolpidem) may be responsible for a host of alleged risky behaviors. If you have been injured as a result of taking Ambien, you may be entitled to compensation for your injuries.  You should consult an experienced product liability attorney to determine whether or not you have a case.  When people are injured by products available on the market, it can be beneficial to report these injuries and to consult an attorney to determine the best course of action. 

Generic Cholesterol Medication Recalled for Containing Glass Shards

There have been many recent reports of dangerous drugs, tainted medications, and products that just don't meet the high standards required for human use and consumption.  But this newest report certainly takes the cake.  Scanning the news this morning, the Wall Street Journal had an article that nearly made me choke on my coffee.

Ranbaxy Laboratories Ltd. is recalling 40 batches of its generic version of Lipitor, Atorvastatin, for glass shards they believe may be present in the medication. This is rather shocking news but the company has taken swift and decisive action to investigate how this could have happened, and have removed lots of the drug they feel may contain these minute glass shards.

Are Consumers at Risk?

According to the Wall Street Journal article, Ranbaxy Laboratories Ltd. is no stranger to manufacturing problems.  In January, the U.S. Justice Department alleged very serious problems with the company's manufacturing processes and entered a consent decree of permanent injunction  at the request of the U.S. Food and Drug Administration (FDA).  Although facilities manufacturing the Atorvastatin line were not included in this complaint, the DOJ consent decree alleges very serious flaws with the company's manufacturing processes, including:

• failure to provide written evidence that drugs are being manufactured safely
• failure to follow up on whether drugs complied with their specifications
• failure to prevent cross- contamination of drugs such as anti-biotics, which could cause some people severe allergic reactions
• failure to prevent contamination of medications
• inadequate testing of medications
• alleged falsified data

According to this decree, the company is inable to produce certain medications in the U.S. market until these manufacturing problems have been fixed.  Could this recent voluntary recall prohibit the company from producing generic Lipitor as well?

If You Have Been Harmed

When consumers obtain medication from their pharmacy, they have a reasonable expectation that these medications are safe for consumption.  Ranbaxy Laboratories Ltd. proactively recalled batches they thought contained the glass shards, but if other batches were similarly contaminated, consumers could find themselves at grave risk of injury and even death.  If you have been injured by one of these medications, it is important to seek immediate medical attention.  Injured consumers may also want to contact a skilled personal injury and product liability attorney as well to obtain compensation for these injuries. 

Congressional Report Suggests Fungal Meningitis Outbreak Was Preventable

Congressional Hearing Releases Report that Suggests Fungal Meningitis Outbreak Could Have Been Prevented

For months we've been following the fungal meningitis outbreak.  We've watched this swell from 7 cases to nearly 440 nonfatal cases and 32 fatal cases.  The NECC, New England Compounding Center, has surrendered its license and recalled their tainted drugs.  Congress has initiated hearings into the outbreak to determine how this could have been prevented.  And many families are suffering as a result of this horrific outbreak.

Could this have been prevented?  Congress has compiled information on the NECC to answer this question.  Where did the NECC go wrong to cause such a frightening outbreak? In a 25 page report released by the House Energy and Commerce Committee, Congress has been able to trace back years of complaints, inadequate safety measures, concerns for hygeine and safety, and regulatory complaints.

The FDA Failed to Act

When it came down to it, the U.S. Food and Drug Administration (FDA) found the NECC lacking in health and safety violations. Instead of taking matters into its own hands, they deferred the decision of what to do with the NECC to their regulatory counterparts in Massachusetts.  A deal was likely struck and years later, 32 people have died and 440 people have fallen ill, at risk for death, from this compounding pharmacy's health and safety violations.

On multiple occasions, the NECC failed to uphold health and safety standards. In 2003, the FDA suggested that the NECC be "prohibited from manufacturing"  in order to avoid these problems. Based on multiple complaints, including one from Colorado, the NECC was accused of behaving more like a drug manufacturer than a pharmacy.  The NECC didn't provide prescriptions like pharmacies did.  Instead, they shipped thousands of drugs across the United States without a prescription.  Had the NECC been treated like a manufacturer, they would have had much stricter standards in place and the FDA could have shut them down.  Ironically, as a pharmacy, the FDA had limited power to act.  The grey area of regulatory power over compounding pharmacies has continued to plague FDA efforts.

What Kind of Violations Did the NECC Have

• 2011- Pharmacy Board cited NECC for providing doctors with blank prescription pads with NECC's information
• March 2002 complaints of patient adverse reactions due to steroids led to an FDA investigation, in which NECC felt it did not have to provide records, barring proper inspection.
• October 2002 patients reported symptoms of bacterial meningitis which led to another FDA investigation where the FDA found 4 of 14 infected samples. The FDA let Massachusetts regulators take the lead.
• October 2004 the Pharmacy Board sent the NECC a proposed agreement which would have included formal reprimands publicly available on their license and 3 year probationary periods. The Pharmacy Board ended this without discipline in another 2006 action.

Congress will be looking into specifically whether or not the FDA and the Massachusetts Pharmacy Board acted appropriately to protect the public.

If you have suffered the effects of fungal meningitis as a result of the NECC's tainted steroids, you could be entitled to compensation.  You should seek a skilled personal injury and product liability attorney.  Call us today so we can help you.

FDA Warns of Dangerous Online Pharmacies in BeSafeRx

U.S. Food and Drug Administration announces BeSafeRx campaign

Do you shop for your prescription medicines online?  Are you sure you’re getting what you bargained for?  The U.S. Food and Drug Administration (FDA) announced today their new national BeSafeRx campaign.  BeSafeRx was launched to warn Americans of the dangers of purchasing their prescription drugs online.

According to the National Association of Boards of Pharmacy, only 3% of online pharmacies actually followed state or federal pharmaceutical regulations.  This means 97% of online pharmacies did not.  In an age where the internet offers increased convenience and rock bottom prices, this is disturbing news.  In response, the FDA wants to encourage people to shop at pharmacies they can trust. 

"Our goal is to increase awareness," FDA Commissioner Dr. Margaret Hamburg told the Associated Press, "not to scare people away from online pharmacies. We want them to use appropriate pharmacies."

The dangers associated with using online pharmacies are great.  There is no guarantee that the drugs you intend to purchase are actually what you’ll receive.  Instead, you may find the following:

·         Fake drugs

·         Contaminated drugs

·         Drugs past their prescription

·         Drugs with the wrong active ingredients

·         Drugs with too high or too low an active ingredient

·         Toxic or poisonous drugs containing arsenic, rat poison

Purchasing these potentially dangerous drugs could lead to death.

Who purchases their drugs online?

Given the inherent dangers of purchasing mystery drugs from mystery purveyors, one has to wonder who purchases drugs online.  According to the FDA, of over 6,000 Americans surveyed, 1 in 4 admitted to purchasing their drugs online. If the sample size is indicative of larger American trends, that means roughly 25% of Americans purchase their questionable medications online.

Interestingly, when asked about their confidence level and trust, only 3 in 10 responded they weren’t confident the purchase was safe.  That means 70% of respondents felt purchasing drugs online was safe.  This is the target group for the BeSafeRx campaign.  The FDA would like to educate that 70% of Americans who are unaware of the severe risks of purchasing their medications online.

How to spot a potentially dangerous online pharmacy

There are some common warning signs that can help you as a consumer spot a potentially dangerous pharmacy:

·         Site allows you to purchase medication without a prescription

·         Prescriptions are administered after answering a series of questions online (this is illegal!)

·         Prices are rock bottom and the discounts are steep if you purchase now

·         Located outside of the United States

·         Not licensed in the United States

If you’ve been injured by harmful/ fake medications

If you’ve been injured after purchasing questionable medications on the internet, seek immediate medical attention.  Do not wait.  Go straight to the emergency room.  Bring the prescription medication with you and be honest with your doctor about where you obtained the medication.  Explain the symptoms you have experienced in great detail.

If an online pharmacy has injured you, you may be entitled to compensation.  Consult an attorney to review your legal rights.