Archive for the ‘Drug Side Effects / Complications’ Category

People’s Pharmacy warns of the Dangers of Reglan

September 2009

Big banner headline in my local newspaper on Tuesday morning, page 5E:
“Long-term side-effects warning on metoclopramide”, it exclaimed in no uncertain terms.

It was the King Features Syndicate Column People’s Pharmacy, written by Joe and Teresa Graedon, devoted to the subject of alternative health care. A woman had written a letter in order to warn readers about the dangers of Reglan. She begins:

“A dear friend was put on Reglan for acid stomach and left on the drug for nine years. The therapy is only supposed to last a few weeks. She now has tardive dyskinesia. Her tongue is enlarged, and she can no longer speak properly. The side effects did not go away when the drug was stopped. Is there anything that can help her? Please warn your readers about Reglan.”

My first thought was, she needs to find herself a good lawyer.

Here is the People’s Pharmacy reply to the letter:

“Answer: Reglan (metoclopramide) was first approved for use in the U.S. in 1980. It is prescribed for digestive-tract problems such as reflux, delayed stomach emptying, and nausea. Although doctors were warned early on that this drug could cause a neurological disorder, it took the Food and Drug Administration almost 40 years to issue a black-box warning about this complication.

On Feb. 26, 2009, the agency cautioned about metoclopramide: “Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment has stopped.”

That friend needs to know about her legal options; if I had been there I would have cleared my throat and said, well, there is Mulligan Law…

The Mulligan Law Firm is a national law firm located in Dallas, Texas, providing information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995.

The Mulligan Law Firm is currently investigating injury claims involving the possible link of Reglan® to Tardive Dyskinesia. If you or a loved one has been seriously injured or even died after taking Reglan ®, it is important that you consult with a legal professional immediately. The Mulligan Law Firm has experienced lawyers standing by to help you.

We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not delay, as your rights and compensation may be lost forever if you wait.

Zimmer Durom Cup: Quotes from the FDA Recall Packet

September 2009

Zimmer Holdings suspended sales of the Durom® Cup in July 2008, after the alleged failure of the implant required additional surgeries.

The same product had been very successfully used in hip replacement surgeries since 2001, in international markets.

So what happened?

Zimmer alleges that the problem was that the doctors installing the cup were not properly trained, and needed additional workshops.

I would like to call your attention to the FDA Durom Cup Recall Packet, dated September 26th, 2007, 162 pages, PDF readily available online, loaded with information.

The recall packet starts with another problem, and it is an interesting one:

Page One
The recall packet begins with a product recall dated September 26th, 2007 – it states,
“Zimmer GmbH is initiating a product recall of the DUROM Femoral Component 54 Code T and the Femoral Component 46 Code L…. This action is being conducted because some products of the above mentioned lot have been mixed up during packaging. The packaging for the 54 mm implant from this lot may contain a 46 mm implant and vice versa.”

Page Five
“Description of event: The packaging contains the incorrect device. In packages labeled for the 54mm, there is a 46 mm and vice versa.”

“…it was determined that inadequate work instruction and line clearance activities were the primary root causes. A risk analysis from this investigation was developed leading to a corrective and preventive action plan.”

Page Fourteen – Fifteen (from the Health Hazard Analysis Section)

“Discoverability: There is a very high degree of probability that a misidentified femoral component can be discovered by the end user when opened in surgery. The size difference for the two components is 8mm for both the outer diameter and the inner diameter of the sphere. The misidentified product would be removed from the package after the femoral bone cuts have already been made…

“… a 46mm implant coming out of the 54 mm packaging would be discovered as it has an inner dimension of 39.4mm and would not fit on a bony stump prepared for a 54mm implant.

…a 54mm implant coming out of the 46mm packaging would be discovered as it has an inner dimension of 47.4 and would be grossly loose if placed on bony stump prepared for a 46mm implant.”

Page Seventeen
“To upsize or downsize 2mm the femoral head. To downsize he would have to remove more femoral bone. To upsize he would have to apply a thicker cement mantle to fit the bone cut for a 46mm. In either case, the fit in the natural acetabulum would not be ideal.”

At the bottom of the page,
“Outcome 4: It is an extremely remote probability that an end user would not notice the 8mm difference in the implants. A large mismatch between the femoral head and the acetabular surface (natural or implant) would occur leading to instability, patient pain, compromised leg length, and certain revision surgery. Again, this is considered remote in probability.”

On page 21 the FDA says it agrees with Zimmer’s action to recall because of mislabeling, because otherwise they’d have to start legal action to remove it from the market. They go on to say:

“These recalls have been classified by the FDA as Class II recalls, since FDA considers these devices to be adulterated and/or misbranded. This device presents a moderate risk of adverse health consequences. Our evaluation indicates that your submitted recall plan is adequate.”

Press releases from Zimmer immediately follow, and never again do we hear about a mislabeled, mispackaged, or wrong sized product.

Suddenly it’s all about training doctors.

Page Twenty-Eight
“All monoblock metal-on-metal acetabular cups are recognized as technically challenging devices to implant.”

Page Twenty-Nine
“However, Zimmer does recognize this is a challenging procedure and thus is strongly recommending surgeons seek further training before attempting further Durom Cup implantations.”

If you have any questions or concerns about problems you or a loved one may have experienced with the Zimmer Durom Hip Replacement Cup, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

Contraceptive Yaz® /Yasmin® Usage Could Lead to Hyperkalemia

September 2009

Yaz® /Yasmin® is a relatively new contraceptive manufactured by pharmaceutical giant Bayer Corp. The pills became very popular in the US, at least partly due to aggressive marketing strategies. Besides contraception, this drug is also being prescribed to treat conditions like premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).

Yaz® /Yasmin® are fourth generation combination birth control pills. Yaz® is to be taken on a 24/4 day cycle, a departure from the usual 21/7 day cycle. Yasmin® is taken on the more traditional 21/7 cycle.

Yaz® /Yasmin® Side Effects

The composition of Yaz® /Yasmin® includes a new type of synthetic progestin called drospirenone. This could cause a dangerous increase in the potassium levels, a condition known as hyperkalemia.

Hyperkalemia could cause heart arrythmias which means the irregular beating of the heart, cardiac arrest which can prove fatal and changes in the nerves or neuromuscular system. Possible side effects of using Yaz® /Yasmin® also include strokes, blood clots, pulmonary embolisms, liver failure, kidney failure, organ failure, pancreatis and so on.

Yaz® /Yasmin® & the FDA

The FDA has sent Bayer a warning letter referring to the misleading claims it has made in its promotional material. It states that they make references and /or suggestions about the efficacy of Yaz® but fail to communicate any risk information associated with the use of these drugs.

Yaz® /Yasmin® Lawsuits
If you or a member of your family have taken Yaz® and have been affected by side-effects due to hyperkalemia (high blood potassium), you might be entitled to compensation. This is the right time to find out whether you will be eligible or not. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245

Hyperkalemia and Yaz®: Additional Risks Explained

September 2009

Some of the most serious side-effects of Yaz®/Yasmin® deal with heart problems.
What follows is a discussion of how medication-induced levels of high potassium (a condition known as hyperkalemia) can cause cardiac arrhythmia or arrest.

“Moreover, YAZ has additional risks because it contains the progestin, drospirenone. Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems.”
From the 2008 FDA Warning letter to Bayer Pharmaceuticals, the manufacturer of Yaz® and Yasmin®.

What is Hyperkalemia?

Hyperkalemia is the scientific term for high potassium levels in the blood. Potassium is a vital contributor to muscle contractions, regulating muscle activity. It also plays an important role in digestion, metabolism, and homeostasis (the electrical/chemical balance of the body).

Main causes of elevated blood potassium are:

• Ineffective elimination, due to kidney or adrenal problems.
• Excessive production, as in taking a medication that increases Potassium levels.
• Potassium held in the cells sifting into the blood

Normally potassium comes in through the food we eat, and the kidneys remove the excess potassium from the body through urination. When the kidneys don’t work well, potassium builds up, and hyperkalemia occurs. Potassium can also build up from an excessive release of potassium from the cells into the bloodstream, triggered by other factors such as tissue traumas (burns are an example.).

Hyperkalemia can be very temporary, or it can be an ongoing, very serious condition. In some people it causes deadly complications; in others it is tolerated and barely noticed.

Heart Problems and Hyperkalemia
The heart is our main muscle, beating with regular contractions, and potassium plays a vital role in the regulation of heartbeat. Too much potassium (hyperkalemia) is a medical emergency because it can throw the heart rhythm off, and cardiac arrest can occur as a result.

Cardiac arrhythmia is defined as is abnormal electrical activity in the heart. The heart beat may be too fast or too slow, regular or irregular. Often hyperkalemia is detected after the fact, once the person is hospitalized with cardiac arrhythmia or has died.

When to Seek Medical Help
Hyperkalemia can have no symptoms at all; some patients report

• Fatigue
• Nausea
• Muscle weakness
• Tingling sensations

More serious symptoms include:

• Breathing pattern changes
• Unconsciousness
• Arrhythmia
• Cardiac arrest

If you suspect you may have hyperkalemia, please consult with your physician immediately so that your blood potassium can be checked and risk assessed.
If you or a loved one have taken Yaz® or Yasmine® and have experienced any of these heart problems, contact Eric W. Gruenwald, Attorney/Lawyer for more information at 866-529-0001, Extension 245.
The Mulligan Law Firm is a national law firm located in Dallas, Texas who provides information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995, and they are currently investigating injury claims involving Yaz® and Yasmin®.

When to See a Doctor: The Beginning of Stevens Johnson Syndrome

September 2009

First described in 1922, Stevens Johnson Syndrome is named for its ‘discoverers’, M. Stevens, and F. C. Johnson, who published A new eruptive fever associated with stomatitis and ophthalmia; report of two cases in children. American Journal of Diseases of Children, Chicago, 1922, 24: 526-533.

SJS is thought to arise due to a disorder of the immune system, described as a reaction to medication or infection. It tends to occur in winter and early spring, and affects twice as many men as women.

“Missed diagnosis is common.” – Emedicine.

Most authors and experts consider Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) to be different levels of severity for the same disease. Because of this, most Medical sources use the term “SJS/TEN”.

How Does it Start?
SJS typically begins with an upper respiratory tract infection, like a cold or flu.

It then behaves like flu for up to two weeks, including fever, sore throat, chills, and headache; in some people there is also vomiting and diarrhea.

Then suddenly, there are blisters in the mucous membranes – especially nose, mouth and eyes. These clusters of blisters last from two to four weeks and are not itchy.

Fever is reported in 85% of cases.

When Should I Get Medical Help?
These are some early warning signs of Stevens Johnson Syndrome:

• Skin pain over large areas of the body
• Blisters, especially on the mucous membranes
• Hives
• Swelling of the tongue and face
• A red or purple rash that spreads
• Shedding skin

Shedding Skin – How Stevens Johnson Syndrome is Classified
The number of people who die from Stevens Johnson Syndrome is related to the amount of skin lost in the sloughing process in the later stages of the disorder. The simplest of the classifications have three stages:

Stevens Johnson Syndrome – less than ten percent of the body surface skin is lost. Between 1% and 5% of patients die.
Stevens Johnson / toxic epidermal necrolysis (SJS/TEN) - 10% to 30% of the skin is lost.
Toxic epidermal necrolysis – More than thirty percent of the body surface area is detached. Mortality is between 25% and 35%.

If you have developed the Stevens Johnson Syndrome (SJS), and have taken the epileptic drug Dilantin®, please speak with us now. You may be entitled to compensation! Contact Eric W. Gruenwald, Attorney / Lawyer, for more information. You can reach him at 866-529-0001, Extension 245.

Reglan® Can Cause Tardive Dyskensia

September 2009

Every year millions of Americans suffer from stomach disorders like diabetic gastroparesis and gastroesophageal reflux disorder (GERD) and get prescribed Reglan® routinely. In a bid for relief, most patients follow their medical practitioner’s prescription blindly, not knowing what may lie in store ahead. Reglan® or metoclopramide can have terrible side effects like Tardive Dyskinesia which can be a very debilitating disease.

Reglan® is available in the form of Reglan® Tablets, Reglan® Oral Disintegrating Tablets, Metoclopramide® Oral Solution and Reglan® Injection.

Reglan® Side Effects
Tardive Dyskinesia is not a dismissible side effect by any count and can alter the health and quality of life of a person as this affects the neurons, nerve cells. The symptoms of this are like drug induced movement disorders and the most alarming thing is that most are rarely reversible.

Tardive Dyskinesia symptoms are uncontrollable movements of the tongue, lips or jaw, facial grimacing, tongue protrusion, lips puckering, involuntary movements of arms, legs, fingers and toes and swaying movements of the trunk or hip. These movements are usually repetitive and jerky.

Tardive Dyskinesia is almost incurable and most victims have to put up with the symptoms for the rest of their lives. Usually, the first symptoms are not noticed by the patients themselves but by family or friends. These may manifest long after Reglan® usage has been stopped.

FDA & Reglan®
On February 26th, 2009, The U.S. FDA announced that manufacturers of metoclopramide must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

The Law & Reglan®
If you or your loved ones have been injured through the use of Reglan®, waste no more time. You are potentially entitled to compensation. Contact Eric W. Gruenwald, Attorney/Lawyer for more information at 866-529-0001 Extension 245.

The FDA Dilantin® Alert: What does it Mean for You?

September 2009

Last year the Federal Food and Drug Administration came out with an alert for Dilantin® (phenytoin), one of the oldest and still most commonly prescribed anti-epileptic, anti-convulsion drugs.

There are a number of other drugs out there for epilepsy and seizure disorders (14 counted on WebMD alone), but the Stanford Hospital and Clinics website says that Dilantin® is the most popular for treatment of partial and secondarily generalized seizures in the United States.

A lot of epileptics and people with other seizure disorders take Dilantin®.

The side-effect being studied in relation to Dilantin® in this alert is an allergic skin reaction that goes by the name of Stevens Johnson Syndrome, or SJS. (TEN, Toxic Epidermal Necrolysis, is also considered to be part of SJS. The really bad part of SJS).

Here’s the Alert, verbatim from www.fda.gov:
FDA ALERT [11/24/08]: FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais.

OK, in plain english, what does this mean?

An allele is half of a genetic pair. The HLA-B*1502 allele is only present (with rare exception) in people of Asian ancestry. At this time it looks like there may be a link between the HLA-B*1502 allele and Stevens Johnson syndrome (SJS) and also Toxic Epidermal Necrolysis (TEN).

The FDA alert does not mean that SJS and TEN don’t occur in other populations; it means that if you are of Asian ancestry, and you do have this genetic marker, there appears to be heightened risk for a rare, life-threatening allergic disorder.

Maybe yes, maybe no…

The FDA Alert continues: The possible risk of SJS from phenytoin and fosphenytoin in patients with HLA-B*1502 is still being studied; however, there is not yet enough information to recommend testing for HLA-B *1502 in Asian patients for whom phenytoin treatment is contemplated.

The FDA point of view seems to be that’s there’s room to worry but nothing conclusive. The SJS/Dilantin® link is important enough to devote money to the study of the HLA-B*1502 allele, but not important enough at this time to mandate routine genetic tests for those taking Dilantin® who are of Asian descent.

The bottom line: if you take Dilantin®, there’s the risk of the Stevens Johnson Syndrome (SJS) side effect, whether you are of Asian descent or not. If you need representation, you’ve come to the right website!

The Mulligan Law Firm is a national law firm located in Dallas, Texas who provides information and resources for injured individuals and their families in all 50 states. The firm has successfully resolved over $600,000,000 in claims for its clients since 1995, and they are currently investigating injury claims involving Dilantin® and Stevens Johnson Syndrome (SJS).

Levaquin Tendon Injuries Now Being Evaluated By Texas, California, & Florida Attorneys At The Mulligan Law Firm

July 2009

Levaquin:
 
Levaquin is a brand-name of Levofloxacin, a synthetic chemotherapeutic agent that belongs to a class of broad-spectrum antibiotics called fluroquinolones. Levaquin is a prescription-based drug that can be used by adults in the treatment of pneumonia, skin-infections, sinusitis, bronchitis, kidney infections, bladder infections, prostate infections, and inhaled-anthrax.

Levaquin Side-Effects:
 
A number of serious side-effects have been associated with the use of Levaquin. Those side effects include Achilles tendon ruptures, ruptures to the shoulder, hand, biceps and thumb. In addition, serious tendon damage has also been reported in patients prescribed Levaquin.
 
Levaquin and the FDA:
 
In October 2008, the Food and Drug Administration issued an alert that stated: “Fluoroquinolones, including Levaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants.”
 
The FDA added: “Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levaquin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their health-care provider regarding changing to a non-quinolone antimicrobial drug.”
 
Levaquin Lawsuits:
 
If you or a loved one has been seriously injured after taking Levaquin, contact us right now. We have experienced lawyers standing by right now to help you. You may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not Delay. Your rights and compensation may be lost forever if you wait.  Please contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001  Extension 245

Accutane® Potential Claims Now Being Investigated Nationwide By California, Texas, & Florida Attorneys At The Mulligan Law Firm

July 2009

Accutane®:
 
Acctutane® (a marketed name of Isotretinoin) is used in the treatment of severe nodular acne. It is generally used in patients who fail to significantly respond to other forms of acne treatments, such as antibiotics. Accutane works by reducing the amount of oil released by oil-glands in the skin, and helps the skin to renew itself.
 
Accutane Side-Effects:
 
Individuals taking Isotretinoin may experience side effects including severe headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, and muscle weakness. Additionally, serious mental health problems, such as depression and suicide, have been reported with Isotretinoin use.
 
Accutane and the FDA:
 
According to the Food and Drug Administration: “Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your health-care professional and pharmacist. If you are pregnant or may get pregnant, Isotretinoin can cause birth defects, miscarriage, premature births, and death in babies. Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, Isotretinoin can cause serious and harmful side effects.”
 
Accutane Lawsuits:
 
If you or a loved one has been seriously injured after taking Accutane, contact us right now. We have experienced lawyers standing by right now to help you. You may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not Delay. Your rights and compensation may be lost forever if you wait.  Please contact Eric Gruenwald, Attorney / Lawyer at 1-866-529-0001, Extension 245.    

 

The Texas, California, & Florida Attorneys / Lawyers Of The Mulligan Law Firm Are Now Evaluating Nationwide Accutane® Injury Cases

June 2009

 The Mulligan Law Firm is evaluating injuries related to the use of the prescription drug Accutane®.  Accutane ® is a registered trademark of Hoffman – La Roche, Inc.

If you or a loved one knows of someone potentially injured by Accutane®, please contact The Mulligan Law Firm immediately. The Firm is very interested in speaking with you as soon as possible, and evaluating and investigating your potential claim at no cost.

Accutane® is an acne treatment drug. 

Accutane® was pulled from the US market in June, 2009.  It is allegedly associated with several serious side effects including Inflammatory Bowel Disease (IBD), Colitis, and Crohn’s Disease.  If you or a loved one suffered any serious side effects after taking Accutane®, the lawyers at The Mulligan Law Firm would like to speak with you concerning your potential case.  Such investigatory consultations are confidential and free.  

Statutes of limitations require potential plaintiffs to act within established time-frames. Any failure or delay in contacting an attorney may result in a potential claimant losing his or her rights.

Do not delay: contact The Mulligan Law Firm today if you have questions and concerns about alleged injuries from the use of Accutane®.

The Mulligan Law Firm:

Since its formation in 1995, The Mulligan Law Firm has successfully represented thousands of individuals in a wide variety of practice areas in federal and state courts throughout the United States, and has achieved recoveries for its clients exceeding well over $600,000,000.00  (Six Hundred Million) U.S. dollars. The firm obtained an AV rating with Martindale-Hubbell which indicates very high to preeminent legal ability and very high ethical standards as established by confidential opinions from members of the Bar.

For more information on potential alleged Accutane® injuries and The Mulligan Law Firm, please see our website.

The Mulligan Law Firm’s Texas, California, and Florida Lawyers / Attorneys are evaluating nationwide claims involving Accutane® injuries. 

The Mulligan Law Firm represents clients throughout the United States in conjunction with local counsel licensed in other jurisdictions.

Contact:

PATRICK J. MULLIGAN, Attorney, Lawyer*
ERIC W. GRUENWALD, Attorney, Lawyer**
The Mulligan Law Firm
866-529-0001, EXT. 245
214-219-9779, EXT. 245
Email:  help@mulliganlaw.com
For details about our attorneys and areas of practice, see:
http://www.mulliganlaw.com

*   Licensed in Texas & Georgia.
** Licensed in California only.