Archive for the ‘Drug Side Effects / Complications’ Category

Avandia® linked to Congestive Heart Failure, Heart Attacks & Fractures

September 2009

Avandia® or rosiglitazone maleate is a prescription drug for diabetics. Manufactured by GlaxoSmithKline, this is specifically used to treat Type II diabetes or non-insulin dependent diabetes. The drug works by helping to control blood sugar levels.

Side Effects of Avandia®
Some of the common side effects resulting from the use of Avandia® are headaches, weight gain, back pain, anemia, broken bones, and increased susceptibility to bruising. The more severe side effects are congestive heart failure and heart attacks. Congestive heart failure can be fatal as the heart will be unable to pump well enough to meet the body’s demand for oxygen. Heart failure symptoms include breathlessness, difficulty in breathing, chest pain, and swelling of the extremities. Heart attacks can also be caused by this drug.

Those who have increased vulnerability to side effects arising from Avandia® use are patients with cardiovascular disease, diabetes-related eye problems, liver disease, and stroke.

FDA & Avandia®
An FDA Alert on 19th November, 2007 called for Avandia®’s manufacturer to modify the prescribing information for rosiglitazone (Avandia®) including a new Boxed Warning. It also called for changes to the label stating the potential increased risk of myocardial ischemia. FDA also requested the manufacturer to create a Medication Guide for patient use that would contain guidelines on the use of rosiglitazone.

On 14th August,2007, FDA announced yet another alert. It called for a new Boxed Warning on Avandia®. It also asked them to update the content under Warnings, Precautions and Contraindications stressing that rosiglitazone could cause or exacerbate heart failure, especially in certain patients. Never stop any medication, including Avandia®, unless under the specific directions of your fully informed and licensed physician / medical doctor

The Law & Avandia®
If you or your loved ones have used Avandia and suffered from side effects like congestive heart failure or heart attacks, you could be entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Fen-Phen Years Ago equals echocardiogram now: Subtle symptoms, hidden damage

September 2009

Fen-Phen was everywhere in the mid nineties. It was the gold standard for obesity treatment, prescribed by weight-loss clinics and M.D.s alike, and widely available through mail order.

The patented drugs used in the Fen-Phen “off label” combination were Pondimin® and Redux®; in 1996 the two drugs made $300 million for their manufacturer, American Home Products, now Wyeth Pharmaceuticals.

As more people used Pondimin® and Redux®, the list of negative reports and studies of serious side effects began to grow longer, and in 1997 both drugs were withdrawn from the US market.

This was over ten years ago.

The problems caused by the drugs were very significant; in the New England Journal of Medicine article that broke the story, Dr. Heidi Connelly of the Mayo Clinic published a study where valvular heart disease and primary pulmonary hypertension (PPH) were identified in 24 women treated with Fen-Phen who had no previous history of heart problems.

Then the FDA became involved, and in a further study 30 percent of the patients being evaluated had significantly abnormal echocardiograms.

These patients reported a total lack of physical symptoms. They had suffered damage, significant damage, but there was no sign.

What was true then could also be true today – heart disease is known as the ‘silent killer’ – and for many people, especially women, the first sign of heart disease from whatever cause might be a massive heart attack.

If you took Fen-Phen back when, for any amount of time, and you have not been evaluated for heart damage, it is important to have an echocardiogram done. The damage done by the drug combination may not be detectable by physical symptoms.

The other major Fen-Phen side-effect, Primary Pulmonary Hypertension (PPH), does have reported symptoms, though they can be subtle in that they are also the symptoms of obesity.

The American Heart Association’s PPH website says that: “One of the great difficulties in treating PPH is that the diagnosis is often delayed due to the slowly progressive and insidious onset of the symptoms.”

Look for tiredness and fatigue, breathing difficulty, fainting spells or dizziness. In later stages of primary pulmonary hypertension there is swelling of the lower extremities, a bluish cast to the skin, chest pain, and coughing up blood.

Take Note

If you or a loved one have taken the Fen-Phen combination weight loss drug, contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com. The consultation is free of charge, and all cases are taken on a contingency-fee basis – you do not pay for any services unless you receive an award or compensation.

Fen-Phen linked to deadly primary pulmonary hypertension (PPH)

September 2009

Fen-Phen was an anti-obesity medication that became very popular in the 1990`s. In fact, in 1996 and 1997, over 6 million people were on this drug which was a cocktail of two drugs fenfluramine and phentermine. It claimed to be a wonder drug that curbed appetite by significantly altering the glucose (sugar) consumption by body tissues.

Side Effects of Fen-Phen

The usage of Fen-Phen can lead to a serious and potential life threatening cardiovascular disorder called primary pulmonary hypertension (PPH). In PPH the blood pressure in the pulmonary artery rises enough to put strain on the heart. The heart has to work much harder, and the result can be symptoms like dizziness, breathlessness, fainting, fatigue, chest pain, and even heart failure.

A study published in the New England Journal of Medicine in August 1996 revealed that the use of Fen-Phen® for a period of three months or longer can result in a twenty-three fold increase in the risk of developing primary pulmonary hypertension (PPH).

Fen-Phen & FDA

In July 1997, 24 cases of rare valvular disease were identified in women who took Fen-Phen by researchers at the Mayo Clinic and Mayo Foundation. The FDA immediately alerted medical doctors since it had received nine more reports to the same effect.

Following this, the, FDA received 66 additional reports of heart valve disease linked mainly to Fen-Phen usage. The reports flowed in continuously and in September 1997, this drug was recalled by the FDA.

Fen-Phen & the Law

If you or your loved ones have used Fen-Phen and faced PPH problems, you could be potentially entitled to receive compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

The Chronicles of Avandia®: Heart Disease Warnings in May of 2007, and thereafter

September 2009

Avandia® has been on the market since 1999, and it has been a hugely popular diabetic drug, controlling blood sugar by the increase of insulin sensitivity. Usually used in tandem with other diabetes drugs, Avandia® was heavily marketed and netted $3.4 billion for manufacturer GlaxoSmithKLine in 2006.

Then came an article published in the New England Journal of Medicine in May of 2007, estimating that Avandia® users faced a 43 percent higher risk of heart attack or cardiovascular event. The article made a huge impression. GlaxoSmithKLine disputed the findings, which were also the subject of much internal dispute within the FDA.

The Food and Drug Administration convened a special meeting to monitor Avandia’s safety risks on July 30, 2007 in Gaithersburg, Md. The finding of the panel was to leave the drug on the market, and on November 14, 2007 a boxed warning was added to Avandia®. The press release says, “Agency says drug to remain on market while safety assessment continues”.

Patients with diabetes already have increased potential for heart disease; it’s a known result of the condition. The American Diabetes Association says that 2 out of 3 people with diabetes die from heart disease and stroke. If you were prescribed Avandia you have been potentially subjected to even higher risks of heart disease.

If you or a loved one have taken Avandia® and have experienced heart attacks or heart disease, or a significant worsening of an already existing cardiac condition, or if someone you know has died as a result of taking Avandia®, contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com The consultation is free of charge.

Excerpts from the November 14 Warning:

FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia
Agency says drug to remain on market, while safety assessment continues
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia…

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Persistent Pulmonary Hypertension of the Newborn: The Ongoing Study of the role of Paxil® and the other SSRIs

September 2009

A baby in the womb does not need to breathe.
Oxygen comes in through the umbilical cord, and while in the uterus, a baby’s circulation bypasses the lungs. When the birth is normal, the baby is born and begins to breathe air and the until-then unused circulatory system ‘wakes up’ and quickly adapts to the new conditions outside the womb. The air is breathed in and the lungs inflate. 

Persistent Pulmonary Hypertension (PPHN): The circulatory system of the baby does not switch to “Breathe” mode.
What happens with Persistent Pulmonary Hypertension is that the circulatory system of the baby does not switch over to now take oxygen from the lungs, and the baby’s blood flow continues to bypass the lungs. The baby breathes, but the oxygen does not reach the bloodstream, and the organs quickly become stressed from lack of oxygen.

What are the Symptoms of Persistent Pulmonary Hypertension?

  • cyanosis – the skin has a blue tinge even with additional oxygen
  • difficulty breathing; flared nostrils of grunting
  • tachypnea – rapid breathing
  • elevated heart rate

PPHN is not common; it occurs in an estimated one out of each 700 births, often as an isolated condition appearing from the time of birth until about twelve hours after birth.

How is the depression/anxiety medication Paxil® implicated in Persistent Pulmonary Hypertension?
As the result of clinical studies, the FDA issued an alert:

Paroxetine (marketed as Paxil®)
FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet)… Neonatal PPHN is associated with significant morbidity and mortality … The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

Considerations: (also from the alert) Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.

SSRI Drug Names: Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine), Symbyax (olanzepine/fluoxetine), Zoloft (sertraline).

Never stop any medication unless under the specific directions of your fully informed and licensed physician / medical doctor.  As the FDA alert above says, this is a work in progress; the FDA will provide more information as it becomes available and more studies are done. In the meantime, if you or someone you know took Paxil® or one of the SSRI drugs listed above while pregnant, and the baby developed Persistent Pulmonary Hypertension, you may be entitled to compensation. Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245 or by email at help@mulliganlaw.com

Paxil® could cause congenital defects in newborns!

September 2009

Paxil® is the trade name for Paroxetine. This can be considered a drug in the class of a selective serotonin reuptake inhibitor (SSRI), in simple terms, an anti-depressant. It was the first anti-depressant in the USA that received formal approval to treat panic attacks. Pharmaceutical giant GlaxoSmithKline started marketing this drug in 1992 to treat acute depression, Obsessive Compulsive Disorders (OCD), social phobia, panic, anxiety and so on.

Paxil® Side Effects

Paxil® side effects have been linked to heart problems in newborns. Two studies by the American College of Obstetricians and Gynecologists published in 2006 pointed out that that use of Paxil® during pregnancy could cause cardiac fetal heart defects, some of which require surgical intervention.

A ventricular septal defect (VSD) affects the ventricular septum, the wall that separates the left and right ventricles of the heart.  Atrial septal defects (ASD) affect the interatrial septum of the heart, the critical tissue separating the right and left atria. A defect in the septum or lack of it makes it impossible for blood to flow from the left to the right of the heart or vice versa. This results in unhealthy mixing of arterial and venous blood. Using Paxil® during pregnancy can also affect fetuses with PPHN (Persistent Pulmonary Hypertension of the Newborn), a dangerous lung disease that can cause heart failure.

FDA & Paxil®

Two studies the FDA had reviewed showed that women who had taken Paxil® in the first trimester of pregnancy increased their risk of giving birth to a child with a heart defect by one and a half to two times. In response, FDA is advising health care professionals to discuss potential risk of birth defects with patients taking Paxil® both those who intend to become pregnant or in their first trimester of pregnancy. It also urges them not to prescribe Paxil® unless other treatment options are inappropriate.

We Can Help

If you were one of those prescribed Paxil® in the first trimester, and if your newborn has a heart defect, you are potentially entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Levaquin® can lead to severe tendon injuries!

September 2009

Levoflaxin is available under the brand name Levaquin® and manufactured by Ortho-McNeil-Janssen Pharmaceutical. This is a powerful quinolone antibiotic prescribed in the treatment of bacterial infections of the sinus, skin, kidney, lungs or urinary tract.

Side effects of Levaquin®

Levaquin® is routinely prescribed, but it can lead to severe side effects.

The major side effect of Levaquin® usage is that it can severely affect tendons. This includes tendonitis, an inflammation of the tendon which is not restricted to any particular part of the body but can occur anywhere and is extremely painful. The most common are Achilles tendonitis, which affects the heel, and patellar tendonitis, which affects the knee. A torn tendon is another possible side effect, causing extreme levels of pain that may even leave a patient permanently disabled. Tendon side effects may not cease once usage of the drug is stopped, and they can last for months after.

The other side effects that could appear are skin rash, hives, skin allergies, heartbeat irregularities, problems with swallowing or breathing, and swelling of areas like the face, lips, tongue or throat. It can affect the nervous system too, manifesting as nerve pain, numbness, weakness, tingling sensations and so on.

FDA & Levaquin®

The FDA has insisted on a boxed warning. It also released the following health alert in October 2008, “Fluoroquinolones, including Levaquin, are associated with an increased risk of tendonitis and tendon rupture in all ages. 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 tendonitis or tendon rupture, and to contact their health-care provider regarding changing to a non-quinolone antimicrobial drug.”

Contact Us

If you find that you and your loved ones have had serious tendon injuries linked to the usage of Levaquin®, you could be legally entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information, at 866-529-0001, Extension 245.

Accutane can cause severe bowel disorders!

September 2009

The drug isotretinoin is marketed under the brand name Accutane. This drug is usually prescribed for those suffering from severe acne. Discovered in 1979, this produced dramatic results on acne-affected skin making it popular amongst patients. However, what they failed to realize was that this drug also brought with it a share of potentially dangerous side effects. This drug which was once the second largest seller amongst drugs from Roche was withdrawn from the market after the large number of cases filed against it on grounds of personal injury.

Accutane Side Effects

Recent studies have also identified that Accutane could have side effects like Crohn’s disease and ulcerative colitis. Crohn’s diseases shows up with symptoms like abdominal discomfort, cramps and diarrhea. Ulcerative colitis involves side-effects such as abdominal discomfort, cramps, rectal bleeding, and bloody diarrhea. These side effects could continue even after usage of Accutane is discontinued.

Accutane has also been known to sometimes cause severe headaches, vision problems, vomiting, dizziness, nausea, seizures, stroke and muscle weakness as well. Depression and serious mental health problems have also been experienced by some patients. And what’s even worse is that this could take one to the brink of suicide.

FDA & Accutane

The FDA has launched a web page that warns users against buying isotretinoin online. It also states that ` All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.’.

The Law & Accutane

If you or your family have fallen victim to Accutane side effects, it is important that you consult with a legal professional immediately. You may be entitled to compensation. Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001, Extension 245.

Levaquin, Flouroquinolones and Seeing Double: New Research

September 2009

A father and son research team has published an article in this month’s journal Opthamology that examines a possible causal link between flouroquinolone antibiotics and double vision.

Noting a pattern of eye problems associated with the drugs, Dr. Frederick W. Fraufelder and Dr. Frederick T. Fraunfelder compiled ‘spontaneous’ event reports related to the drugs from a variety of sources, including the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, and the FDA.

171 event reports of diplopia (double vision) were linked to flouroquinolones, drugs widely used to treat infections, and with a list of side effects that gets longer by the day – the most oft-noted one being tendinitis and tendon rupture, linked with the flouroquinolone Levaquin.

At this point the reason why the diplopia occurs is not proven; the researchers said it could be that the drug affects the tendons controlling the eye, interfering with the ability to focus.

However, “According to the World Health Organization criteria, the relationship between flouroquinolone therapy and diplopia is possible.”

The total number of cases may seem small, but in Thomas Maugh’s L.A. Times blog entry he says “…experts note that fewer than 10% of such complications are routinely reported to monitoring bodies.”

Here are the stats on the cases studied: 75 were related to Cipro, 9 to Tequin, 20 to Levaquin, 16 to Avelox, 11 to Noroxin, and 40 to Floxin, with the numbers across the board in proportion to the prescriptions written.

The flouroquinolone drug was stopped in 53 of the cases, and in all of these the double vision stopped and normal vision came back. There were, additionally, five subjects where the patient was given the drug a second time and experienced double vision a second time.

The outcome of all this?

“Doctors need to be aware of this potential reaction when prescribing these antibiotics and consider stopping therapy if diplopia occurs,” Dr. Fraunfelder said.

If you have any questions or concerns about side-effects you or a loved one may have experienced with the flouroquinolone drug Levaquin, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

Why Accutane was Withdrawn: The Bloomberg Article

September 2009

On June 26, 2009, Roche Holding AG pulled Accutane, the acne drug, from the U.S. market. Bloomberg reporters Jef Feeley and Sophia Pearson filed an article that day that has been cited many times and is excerpted here.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.”

The article goes on to say that Accutane went on the market in 1982, and until the patent expired (in 2002) it was taken by approximately 13 million people and netted the drug firm its second-highest sales.

The boom is over; a company representative told Bloomberg that Roche’s market share for Accutane by prescription is now below 5 percent.

Bloomberg communicated with Shelley Rosenstock, a spokeswoman for Roche’s Nutley, New Jersey-based U.S. unit, who said in an e-mailed statement that Accutane’s safety wasn’t part of the decision to yank it off the U.S. market. She said Accutane has also been withdrawn in 11 other countries, including France, Denmark, Austria, Germany, Portugal, Norway and Spain.

“Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” she said in the statement.

At the time the Bloomberg article was written, Roche faced as many as 5,000 personal-injury claims over Accutane.

If you have any questions or concerns about side-effects you or a loved one may have experienced with Accutane, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com