FDA Warns Celexa May be Dangerous to the Heart

Posted on August 30, 2011 by Kay Van Wey

Dallas dangerous drug attorney talks about new dangers of Celexa

Celexa (generic name Citalopram Hydobromide) is a selective serotonin reuptake inhibitor (SSRI) that is commonly used to treat depression by increasing serotonin in the brain to improve mood. But based on recent studies showing that Celexa poses heart-related risks, the Food and Drug Administration (FDA) has restricted the dosage at which Celexa may be prescribed.

The FDA made the label change after studies showed that Celexa causes abnormal heart rhythms and has no therapeutic benefit when taken at a high dose.  Doctors will no longer be able to prescribe the drug at doses higher than 40mg.  Generics of Celexa are also included in the label change. 

Patients at risk for experiencing an adverse cardiac event while on Celexa include those with underlying heart conditions and those with low levels of magnesium and potassium in the blood.  Doctors are not to prescribe the drug to patients with congenital long QT syndrome (CQTS), a condition which affects the electrical system of the heart and can lead to cardiac arrest or sudden death.
 
The FDA recommends that patients taking Celexa consult their doctor before discontinuing the medicine, as serious side effects may occur after discontinued use.  If you are currently taking Celexa and are experiencing a shortness of breath, irregular heartbeat, or dizziness, the FDA recommends you see a doctor right away.  Report any adverse events experienced while on Celexa to the FDA's MedWatch Program at 800-332-1088.
 
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Girl Injured by Children's Motrin Still Suffering 10 Years Later

Posted on August 24, 2011 by Kay Van Wey

In 2000, three year-old Brianna Maya was given Children’s Motrin.  Shortly after, she developed a rash on her body and redness around her eyes.  Brianna was having an adverse reaction to the Motrin, and it was only going to get worse.

A few weeks later a painful and potentially fatal skin reaction had burned her body, blinded her in one eye, and sent her more than 1,000 miles from home to the Shriners Burn Hospital in Galveston, Texas.  Brianna had developed Stevens-Johnson syndrome in which the mucus membranes of the cornea, mouth, and rectum are broken down after blistering.  She also developed toxic epidermal necrolysis syndrome (TENS), which is a more severe form of Stevens-Johnson syndrome and affects a larger area of skin and mucus membranes.

Over 10 years later, Brianna is still suffering from the adverse reaction she had to the Children’s Motrin.  She has had to undergo eye surgeries and has developed seizures.  More than 84 percent of her skin is gone.  She has suffered brain damage due to the lack of oxygen to her brain over the years. She continues to develop lung infections, which affect her breathing.

Brianna’s mother never knew that a seemingly safe over-the-counter medicine could do so much damage to her daughter. No warning of the syndromes was given on the drug's label.

After finding that Brianna suffered an adverse reaction to the drug in 2000, a jury in Pennsylvania awarded Brianna $10 million.  Of course, no amount of money will ever compensate Brianna for the pain and suffering she has had to endure throughout her childhood.

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Safety of New Anti-Depressants Questioned for Seniors

Posted on August 22, 2011 by Kay Van Wey

Dallas dangerous drug attorney Kay Van Wey

Selective serotonin reuptake inhibitors (SSRIs) are considered the latest innovations in the treatment of depression.  Drugs like Prozac, Celexa, and Zoloft have become the second most-popularly prescribed drugs in the United States.

Last year, more than 254 million prescriptions were written for anti-depressants in the United States, for which consumers shelled out $10 billion.  
 
But are these drugs safe for everyone?
 
We know that certain SSRIs like Paxil can cause birth defects in children born to mothers who took the pills while pregnant.  Now a new study published in the British Medical Journal shows that these drugs may also be dangerous to patients ages 65 and older.
 
The study highlighted in the British Medical Journal found that patients on SSRIs who were 65 years or older were more likely to suffer adverse effects from taking the anti-depressants than their peers who were not taking them.  Furthermore, SSRIs were found to be more harmful than older anti-depressants known as tricyclics.
 
Researchers are not sure why SSRIs seem to pose more of a danger to seniors, but they believe it has something to do with the fact that many seniors who suffer from depression also suffer from other medical conditions like diabetes or heart disease.  Elderly patients with these other conditions may be taking several medications at once, contributing to an adverse reaction.
 
The effects of SSRIs on seniors are still largely unknown because seniors are usually underrepresented in clinical trials for anti-depressants.  Doctors say that as with any drug, the relative benefits of taking SSRIs must be considered along with the risks to the patient.
 
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Darvocet, Darvon and Propoxyphene Products Liability Update

Posted on August 19, 2011 by Kay Van Wey

On August 16, 2011, the United States Judicial Panel on Multidistrict Litigation “MDL Panel” created a new multidistrict litigation (“MDL”) for Darvocet, Darvon, and Propoxyphene products liability cases, finding that centralization of these cases is appropriate under 28 U.S.C. § 1407.  The MDL Panel decided to centralize the cases in the Eastern District of Kentucky (Covington Division).  With the consent of that court, the cases will be assigned to Judge Danny C. Reeves.  Accordingly, the MDL Panel ordered transfer of the seventeen actions before it for consideration to the Eastern District of Kentucky (Covington Division).

Defendant drug manufacturers and pharmaceutical companies opposed centralization of the cases.  However, the Panel sided with the plaintiffs, who argued for centralization on the grounds that all of these cases share complex questions of fact concerning the safety of Darvocet, Darvon and Propoxyphene.  According to the Panel, the cases share factual issues as to 1) whether Darvocet, Darvon, and other medications containing Propoxyphene were defectively designed and marketed, 2) which defendants manufactured, licensed, or sold Propoxyphene products during various times, and 3) whether defendants knew or should have known of the increased risk of cardiovascular injuries with these medications and failed to provide adequate warnings of them. 
 
The MDL concerns cardiovascular injuries associated with Darvocet, Darvon and other medications containing Propoxyphene.  However, the MDL Panel left open the question of what particular cardiovascular-related injuries are or are not appropriate for inclusion in this MDL. 
 
Darvocet, Darvon, and Propoxyphene products were removed from the U.S. market in December 2010 because the risk of cardiac complications and deaths related to the drugs outweighed the benefits that the drugs afforded for pain relief.  Since then, about thirty-five cases have been filed against the companies responsible for manufacturing the drugs.  Many more cases are expected to be filed in the future.
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Big Pharma Company Found Guilty of Deceptive Marketing

Posted on August 12, 2011 by Kay Van Wey

risperdal Pictures, Images and Photos

State governments are taking matters into their own hands when it comes to dangerous drugs.  Under the South Carolina Unfair Trade Practices Act, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has been ordered to pay the state $327 million for deceptively marketing its drug Risperdal.

Risperdal is an antipsychotic drug used to treat schizophrenia.  Known as a blockbuster drug, Risperdal made $1.5 billion in sales in 2010 alone.  South Carolina estimates that 620,000 prescriptions of Risperdal were written for residents on Medicaid and the state health plan.

Last March, a jury found that Janssen had violated the unfair trade law by sending misleading letters to 7,200 South Carolina doctors.  In the letters, Janssen downplayed the risk to patients of contracting diabetes while on Risperdal.  The company also claimed that the drug was safer than its counterparts manufactured by other companies.

Judge Roger Couch, who entered the order against Janssen, found that the company knew about the risks associated with taking the medicine, but intentionally concealed the studies from the public.  Of the deceptive act, Judge Couch said “There is absolutely no doubt in my mind that the desire to protect market share overshadowed the good judgment of those in control at Janssen.”

Can Texas consumers trust that Janssen did not do the same in this state?

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Primary Care Doctors Prescribing More Anti-Depressants

Posted on August 8, 2011 by Kay Van Wey

Depression Pictures, Images and Photos

Over the past few years, anti-depressants have become blockbuster drugs and have skyrocketed to become the second most-prescribed drug, after cholesterol-lowering drugs.  And more primary care doctors, or other doctors not trained in psychiatry, are prescribing these powerful and potentially dangerous drugs.

 
Nearly three-quarters of all prescriptions for anti-depressants are written without a specific diagnosis.  This has medical experts worried that anti-depressants are being prescribed too often to patients who may not need them.
 
According to IMS Health, an estimated total of 254 million prescriptions were written for anti-depressants last year alone, up from 231 million in 2006.  Each year, Americans spend $10 billion on anti-depressants. Additionally, seven percent of all visits to a primary care doctor end up with a prescription being written for anti-depressants.
 
Medical experts worry that this alarming new trend may be due to the direct to consumer advertising that so many pharmaceutical companies use to sell their drugs.  Advertisements that ask people whether they are sad or are having trouble getting out of bed in the morning are not just meant to get those who are depressed to ask their doctors for these powerful drugs, but are meant to make the general population question whether they are depressed and whether anti-depressants could make their lives better.
 
Studies show that many people on anti-depressants take them for minor complaints like nervousness, sleep problems, everyday stress, and an inability to quit smoking.  According to Dr. Ramin Mojtabai, the lead author of the most recent anti-depressant study published in Health Affairs and a professor of psychiatry at Johns Hopkins, “[a]lthough these drugs do not have many acute side effects, there may be more long-term adverse effects,” including withdrawal, weight gain, and diabetes.
 
Dr. William Narrow of the American Psychiatric Association says that most people with mild depression may do better with psychotherapy than with anti-depressants.  Dr. Mojtabai agrees, saying that there is scant evidence that anti-depressants offer relief from vague complaints like stress, relationship problems, or low self-esteem.
 
If your doctor is recommending you go on an anti-depressant, ask yourself “Do I fit the criteria” and “Will the medication be more effective than placebo?” before trying to find a "cure" in a pill.
 
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Tylenol Lowers Daily Recommended Dose

Posted on August 1, 2011 by Kay Van Wey

Tylenol! Pictures, Images and Photos

Do you take over-the-counter (OTC) pain medications daily at the maximum recommended dosage?  If so, you may be over-medicating yourself.  

Johnson & Johnson, the manufacturer of the popular OTC pain pill Tylenol recently announced that it would be reducing the recommended dose of its Extra Strength Tylenol from 4,000 mg or eight pills a day to 3,000 mg or six pills a day.  Tylenol contains acetaminophen, which is found in more than 600 medicines, including Alka-Seltzer, Nyquil, and Sudafed.   People mixing these medicines often unknowingly overdose on acetaminophen.
 
So why is Johnson & Johnson changing its dosing instructions now?  More than 56,000 Americans are hospitalized each year after overdosing on acetaminophen, which can cause liver failure.  In fact, acetaminophen overdoses are the leading cause of liver failure in the United States and lead to nearly 458 deaths each year.
 
Because acetaminophen is found in so many other OTC products, Johnson & Johnson thought it would be best for consumers if the company lowered the daily recommended dose.  New labels on Extra Strength Tylenol with the reduced dosage will start rolling out this fall.  Next year, Johnson & Johnson will also change the dosing instructions on its regular Tylenol.
 
While health experts are praising Johnson & Johnson for voluntarily changing the labels to reflect the lower recommended dosage, they are also worried that companies that produce similar OTC products are not informing consumers sufficiently about these medicines and how they may interact with other medicines.
 
Beginning as early as 2009, some medical experts called on Johnson & Johnson and the Food & Drug Administration (FDA) to lower the recommended dose to as little as 2,600 mg per day.  They also urged the major pharmaceutical company to require a prescription be written for Extra Strength Tylenol 500 mg.  Neither of these changes were made at the time, and Extra Strength Tylenol is still available as an OTC medication.
 
In recent years, Johnson & Johnson has suffered major setbacks in manufacturing several of its popular OTC drugs.  Just this year, the company recalled 43 million packages of Tylenol, Benadryl, Sudafed, and Sinutab products because the equipment used to produce the drugs was not sufficiently cleaned.
 
Even with “safe” OTC drugs on the market, pharmaceutical companies need to help consumers understand what ingredients are in the medicines they are taking, how those interact together, and the maximum dosage of each drug they should be taking per day.
 
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