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Pharmaceutical Litigation Archives | Farah & Farah

Proton Pump Inhibitors- Be Careful of Larry the Cable Guy

By Farah & Farah on February 27, 2017

You might want to think twice before taking medical advice from Larry the Cable Guy.

Larry tells you to take “One pill every morning” of Prilosec OTC (over-the-counter) medication to treat your frequent heartburn by decreasing the amount of acid in the stomach. Go ahead and eat that greasy plate of ribs.   

We are looking at new cases of kidney injury among Americans who take Prilosec and its next generation of Proton Pump Inhibitors (PPIs), Nexium, the little purple pill, both blockbuster drugs for global drug company AstraZeneca.

The kidneys are a pair of organs located in the back of the abdomen. Their job is to filter the blood.  PPIs may damage the kidneys by causing magnesium levels to drop. The use of PPIs may also cause acute kidney inflammation.

Prilosec still doesn’t have a warning about AIN (Acute Interstitial Nephritis), a drug-related kidney disease that can lead to organ failure. Nexium’s label does not have any specific warnings about these side effects even though the first report of Prilosec-induced AIN was published in 1992.

A published study in JAMA (Journal of the American Medical Association) Internal Medicine in February 2016 found using PPIs is associated with a 20-50% higher risk of developing chronic kidney disease, than among nonusers.

The drugs are actually intended for limited use up to 14 days, three times a year, so Larry has it all wrong with his “Pill a Day” prescription.  Still the ads continue.

To make matters worse, AIN can be asymptomatic and permanent leading to acute kidney failure or kidney injury. Stage 5 is the complete loss of kidney function leading to kidney dialysis and/or a kidney transplant.

Anyone taking these drugs long-term who suspects kidney damage might want to consider a series of blood tests which include BUN testing to measure blood nitrogen, used to diagnose kidney function. 

Doctors can measure the amount of blood creatinine, a waste product, to test the kidney function. Calcium tests screen for kidney disease as does a blood phosphorous test. 

Patients with kidney failure may have severe anemia from a lack of red blood cells.

AIN should be diagnosed early to avoid permanent kidney damage.

Besides kidney damage, plaintiffs have named AstraZeneca’s PPIs in defective product lawsuits accusing the company of failing to warn about an increased risk of bone fracture, heart attack, stroke and dementia.

The Judicial Panel on Multidistrict Litigation held a hearing late January 2017 to consider whether the growing number of PPI cases should be consolidated into one federal court for pretrial proceedings.

Questions Arise About Brain Supplements

By Farah & Farah on February 22, 2017

It’s a good idea to ask questions about supplements. After all, the U.S. Food and Drug Administration does not regulate the industry other than to clamp down on outrageous claims of muscle strength, sexual enhancement or heart health.

Brain boosters are the latest type of supplement that promise to keep your brain agile into your later years when Alzheimer’s disease threatens to wipe out memory and cognitive function. But are the benefits believable?

What is believable is that the supplement industry has enjoyed a ten-fold increase in the number of brain-boosting supplements marketed in the U.S. in the last twenty years.

According to Fair Warning, health product retailer GNC lists 354 products on its website with the word “brain.”

Sparked by the claims made by Quincy Bioscience of Madison, Wis. the makers of Prevagen, the Federal Trade Commission and New York State authorities sued the maker alleging the company makes false and unsubstantiated claims. 

New York Attorney General Eric Schneiderman believes the aggressive marketing is fraud that targets a vulnerable group – older Americans. A bottle of Prevagen can run as high as $69.

Prevagen’s ads say its key ingredient, the protein apoaequorin, was originally discovered in a rare jelly fish. In truth, the company makes the ingredient in a lab to save the cost of harvesting from jellyfish.

The Food and Drug Administration (FDA) says a supplement must be a food or all-natural, not made in a lab. Otherwise it is an unapproved drug. 

The Federal Trade Commission, in its complaint, believes there is no scientific truth that Prevagen will improve memory. It points to the company’s own clinical study that “failed to show a statistically significant improvement” in the treatment group when compared to a placebo group.

Quincy says the allegations are unfounded and points to its double-blind placebo-controlled study on brain performance.

The General Accounting Office is exploring whether brain supplement marketing claims are true.

Where does all this leave the consumer?

It may come down to who do you trust? Many consumers see supplements as a low-cost alternatives to drugs with fewer side effects and believe the FDA may be doing the bidding of the pharmaceutical industry which would love to market its own version of Prevagen for profit.

If vulnerable Americans were really being served, our regulators might require further proof of the claims made by the $37 billion a year dietary supplement business, rather than file actions to shut them down. 

Consumers should be suspicious of exaggerated or unrealistic claims whether made by the supplement industry or the pharmaceutical giants.

We’ve seen far too many examples of the FDA as a toothless tiger that has not done its due diligence to make sure that products on the shelf, whether a drug or supplement, are safe and effective.

EpiPen Scandal – Big Pharma, Big Greed

By on September 15, 2016

profitsThe CEO of Mylan Pharmaceuticals has become the latest poster woman for corporate greed–the kind of publicity that no one wants. This fierce consumer backlash was directed at Heather Bresch after her company, Mylan, bumped the price of its lifesaving EpiPen from $124 to over $600. That’s a 400 percent jump in just seven years. Bresch says it’s not the company’s fault, blaming it on the healthcare supply chain system, which she says is “broken” and in need of an overhaul.

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Price of Lifesaving EpiPen Soars; Mylan Accused of Prioritizing Profits Over People

By on August 26, 2016

epi-penEpiPen is the brand name for an epinephrine injector sold by pharmaceutical giant, Mylan NV. Epinephrine injectors are pen-sized devices allergy sufferers use to curb the effects of severe allergies that are often times fatal to the user if action isn’t immediately taken. Those suffering from allergies are advised to keep EpiPens handy at all times as a life-saving measure to stop the harsh effects of substances they’ve been exposed to.

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Injuries Related to Hernia Repair Mesh

By on May 5, 2016

Hernia repair mesh has been in use since the 1950s, but has never been without its risks. Hernia repair mesh is either made from animal sources like pig or cow, or is entirely synthetic. Animal-based mesh is absorbed by the body, while a synthetic mesh is medically considered a permanent implant. Use of hernia repair mesh has been on the rise in the last two decades, and so has the incidence of complications associated with it. Among the injuries associated with hernia repair mesh implants are the following: Read the rest »

Texotere and Permanent Hair Loss

By on April 14, 2016

The chemotherapy drug Taxotere (docetaxel) is commonly used to treat various types of cancer. While temporary hair loss is a common side effect associated with different types of chemotherapy drugs, Taxotere has been shown to cause permanent hair loss (permanent alopecia). Unfortunately, the drug’s manufacturer, Sanofi-Aventis, only began warning of this side effect on its labeling in the United States in December of 2015. What’s particularly disturbing is that Sanofi-Aventis may have known about this side effect as early as 2005 when the manufacturer issued a warning to the European Medicines Agency regarding permanent hair loss.

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Big Pharma Settlements Continue To Set Records

By on December 23, 2013

Jacksonville Pharmaceutical LawyersThe price of doing business continues to rise for Big Pharma.

Pharmaceutical companies have paid billions in settlements since 2010 — a trend that does not appear to be waning. The allegations against pharmaceutical and medical device companies include manufacturing defective devices, illegally marketing medications for off-label purposes and withholding information about the health risks of their drugs.

According to Public Citizen, a health care advocacy group, Big Pharma has paid some 10.2 billion in settlements since 2010. Pharmaceutical giant Johnson & Johnson alone accounted for over $5 billion of that amount.

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Lipitor Lawsuits Claim Pfizer Knew of Diabetes Connection

By on December 11, 2013

It is the best-selling drug in pharmaceutical history, but now the cholesterol-lowering medication Lipitor is under fire from patients who claim that the Pfizer-made drug changed blood sugar levels and seriously raised their risk of developing Type 2 diabetes.

Pfizer engaged in a massive advertising campaign when Lipitor was released; a campaign that urged patients to talk to their doctors about the benefits of the cholesterol medication. It obviously worked. It has been estimated that Pfizer generated some $125 billion in sales before Lipitor became available as a generic in 2011.

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The Fungal Meningitis Outbreak: One Year Later

By on November 4, 2013

Florida Pharmaceutical LitigationIt was a year ago that the largest outbreak of a healthcare-related infection ever reported in the U.S. was announced. Of course, we are referring to the tragic outbreak of fungal meningitis caused by contaminated lots of methylprednisolone acetate (MPA). The contaminated injectable steroid has been linked to 751 cases of fungal meningitis nationwide — and 64 patients died of the disease.

Frighteningly, a case of the infection cropped up as late as July of this year.

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U.S. Supreme Court Blocks Generic Drug Liability Suits

By on July 1, 2013

The pharmaceutical injury attorneys at Farah & Farah in Gainesville previously reported that the U.S. Supreme Court had taken on a case that could have large implications when it comes to bringing liability lawsuits against generic drug makers.

The Court has ruled on that case, and the Justices, in a 5-4 vote, sided with generic drug manufacturer Mutual Pharmaceutical Co., overturning a multimillion-dollar award issued by a New Hampshire jury in a generic drug liability case.

In its ruling, the majority of the Court said that a generic drug manufacturer cannot be sued under state laws for adverse reactions to their products because the prescription drugs they are based on have already been approved by the U.S. Food and Drug Administration (FDA).

The Supreme Court ruling stems from a case in New Hampshire in which a woman sued Mutual after she had a severe adverse reaction to suldinac, a non-steroidal anti-inflammatory generic drug the company produced. The woman’s skin peeled off, she was left nearly blind and she was severely disfigured.

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The attorneys of Farah & Farah in Jacksonville, Florida have experience with personal injury, medical malpractice, product liability, workers’ compensation, social security, injury and negligence lawsuits. Eddie Farah and our team of Jacksonville attorneys are proud to represent working people and families throughout the country.

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