Drug Defects Attorney

Dangerous drugs are fast tracked by the FDA all the time.  Trouble is, often many of the dangerous side effects of these drugs aren't known for years to come.

NEWS ALERT:

Tuesday, June 15, 2010: In another burst of drug recalls for Johnson & Johnson (JNJ.N), the company on Tuesday said it has recalled four additional lots of Benadryl allergy tablets and one lot of Extra Strength Tylenol gels.

The diversified healthcare company, in a press release, said it was recalling the lots after inadvertently failing to include them in a wider recall of over the counter drugs on January 15.

The company's McNeil Consumer Healthcare unit said the latest action is a "follow-up" to the recall in January. On that occasion, 53 million bottles of a range of products were recalled after consumers complained of musty or moldy odors.

The brands included Tylenol and Motrin painkillers, Rolaids, Benadryl and St. Joseph's Aspirin. All told, the J&J unit has issued four product recalls in the past year due to quality control problems at its plants, sparking a Congressional investigation and ongoing scrutiny by the U.S. Food and Administration.

"This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson," Edolphus Towns, chairman of the U.S. House of Representatives Oversight and Government Reform Committee Chairman, said in a statement.

"I am troubled by what we have learned so far in our investigation and this latest development adds to my concern."

J&J declined to comment on Towns' statement.

The drugmaker said the odor that prompted its Jan. 15 recall was linked to traces of a chemical called TBA, caused by the breakdown of a chemical applied to wood used to build pallets that transport and store product packaging materials.

"Further analysis confirms that the risk of serious adverse medical events is remote," J&J said on Tuesday.

J&J said the newly recalled lots -- made at a plant in Las Piedras, Puerto Rico -- were sold in the United States, Trini

The recall affects all unexpired lots of liquid Tylenol, Motrin, Zyrtec and Benadryl formulated for youngsters - more than 43 products. Parents rely on the medications to ease their children's aches and pains, fevers and allergy-associated runny noses and sneezes.

The U.S. Food and Drug Administration advised families to stop using the products, noting some may contain "tiny particles" while others have too many active ingredients or inactive ingredients that don't meet specifications. McNeil Consumer Healthcare, the manufacturer, and federal officials said the prospect of serious medical problems is "remote."

McNeil did little to calm parents' fears with a hotline (888-222-6036) that featured a verbal rendition of the company's press release on Sunday. That release, including a list of all affected products and their lot numbers, is available at www.mcneilproductrecall.com. McNeil is a unit of Johnson & Johnson.

The Paxil Problem

Paxil® (paroxetine) is a type of antidepressant, known as a selective serotonin reuptake inhibitor (SSRI), that works to relieve depression by blocking the re-absorption of serotonin within the brain. Paxil® is prescribed to treat depression, generalized anxiety disorder, social anxiety disorder, panic disorder, and obsessive-compulsive disorder.

Paxil  is manufactured by GlaxoSmithKline and used in the treatment of depression. 

Paxil and other SSRIs have been implicated in a heightened risk of suicide for depressed patients and the FDA recently recommended that the drug not be prescribed for children under the age of 18.

Other Paxil side effects include weight gain, dependency symptoms and difficult withdrawal, other psychological symptoms including panic attacks, anxiety and aggressiveness.  Paxil should not be used in pregnant women, as it has been linked to birth defects. 

Paxil fast facts

Name:  Paxil

Generic:  Paroxetine HCI

Manufacturer:  GlaxoSmithKline

Date approved:  1992

Status: Prescription only

Approved uses:  Treatment of depression, obsessive compulsive disorder (OCD), panic disorder, and social anxiety disorder

Off-Label uses:  Treatment of depression symptoms in children

Side effects:  Homicidal and suicidal tendencies, difficult withdrawal with marked dependency symptoms, psychological symptoms including anxiety attacks and mood swings. A marked risk of suicidal thoughts and suicide attempts has been noted in children under 18.

Paxil is available in tablet and liquid form.  Paxil liquid is orange-flavored and orange-colored.  Each 5mL dose contains the equivalent of 10mg of Paxil.  The liquid should be shaken well before using, and stored at or below 77 degree F (25 C).  Paxil tablets are oval-shaped and film-coated to make swallowing easier.  They are available in various strengths and come in different colors according to their strength.

• Yellow: 10 mg, marked on the front with "PAXIL," on the back with "10."
• Pink: 20 mg, marked on the front with "PAXIL," on the back with "20."
• Blue: 30 mg, marked on the front with "PAXIL," on the back with "30."
• Green: 40 mg, marked on the front with "PAXIL," on the back with "40."

Paxil dangers

There are many dangers of Paxil that patients should be aware of before they begin a treatment regiment that includes the use of Paxil. Paxil is a Selective Serotonin Reuptake Inhibitor (SSRI) that was approved by the FDA to treat a variety of emotional conditions including depression, general and social anxiety disorder, post traumatic stress disorder, and obsessive compulsive disorder.

There are some people for whom the dangers of Paxil outweigh its intended benefits. The dangers of Paxil may make the following patients poor candidates for Paxil treatment: people with a history of seizures, glaucoma, poor circulation, kidney, and liver problems, women who are pregnant or breastfeeding, people who have had problems with similar medications, people under the age of eighteen or older than sixty, and people who are taking or have recently taken MAO inhibitors or other drugs that interact with Paxil. People who consume alcohol might also experience the dangerous side effects of Paxil.

Doctors with patients who take Paxil also warn about the adverse side effects of a Paxil overdose. In the last decade there have been nearly 500 accounts of Paxil overdose; 49 of which resulted in fatality. The largest reported overdose of Paxil that was survived was thirty-three times the maximum recommended dose of Paxil (at 2000 milligrams). There are several dangers of Paxil overdose including the following health symptoms: somnolence, coma, rapid heart beat, tremors, convulsions, vomiting, confusion, nausea, aggression, renal failure, and much more.

Paxil side effects

Patients have reported many troubling side effects after taking Paxil.  These side effects include:

• Birth Defects including;
  • Congenital Heart Defects, Atrial or Ventricular Septal Defects (hole in heart)
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Abdominal Birth Defects / Omphalocele
  • Cranial Birth Defects / Craniosynostosis

In recent studies, the most common side effects of Paxil included:

• Suicidal thoughts or behavior
• Anxiety, agitation, or panic attacks
• Hostility or aggressiveness
• Engaging in unusual or dangerous activities
• Extreme elation or feeling of happiness that may switch back and forth with a depressed or sad mood
• Other unusual changes in behavior
• Signs of serotonin syndrome (a rare but dangerous problem associated with certain medications), such as:
  • Confusion or other mental changes
  • A rapid heart rate
  • Nausea, vomiting, or diarrhea
  • Hallucinations
  • Blood pressure changes
  • An irregular heart rhythm
  • Overactive reflexes
  • Fever, sweating, or shivering
  • Shakiness
  • Agitation
  • Seizures
  • Coma

Signs of an allergic reaction to Paxil include:

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Unexplained rash

• Hives
• Itching
• Unexplained swelling
• Wheezing
• Difficulty breathing or swallowing.

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Less Common Side Effects of Paxil

Rare side effects of Paxil were reported in 2 to 5 percent of people taking the drug. Some of these side effects include but are not limited to:

    * Abdominal pain (stomach pain)

    * Flushing (redness of the skin, especially the face)

    * Gas

    * Increased appetite (see Paxil and Weight Gain)

    * Muscle pain

    * Abnormal dreams

    * Trouble concentrating

    * Sore throat

    * Vision changes

    * Chest pain

    * Back pain

    * Personality changes

    * Muscle spasms

    * Runny or irritated nose

    * Bladder problems

    * Vomiting

    * Heartburn or indigestion (dyspepsia)

    * Feelings of a rapidly or forcefully beating heart (palpitations)

    * Memory loss (amnesia)

    * Taste changes

Paxil drug interactions

Many people begin taking Paxil because they have thoughts about suicide especially when they are younger than 24 years old. After first prescribing Paxil most doctors check regularly with patients for at least the first 12 weeks of treatment.

Doctors are on the lookout during this time period for any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if the patient feels impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting themselves. Paxil may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, patients may have a relapse of depression if they stop taking the Paxil antidepressant during pregnancy.

Doctors warn patients not to take Paxil together with pimozide (Orap), thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with Paxil. Doctors tell their patients to wait at least 14 days after stopping an MAO inhibitor before taking Paxil. After patients stop taking Paxil, it is advised to wait at least 14 days before taking an MAOI.

Before taking Paxil, patients should tell their doctor if they are allergic to any drugs, or if they have liver or kidney disease, a bleeding or blood clotting disorder, seizures or epilepsy, bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.

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Paxil birth defects

While the dangerous effects of off-label use Paxil on children and adolescents and its dangerous withdrawal symptoms have been the main focus in the news, there is also growing concern regarding the use of Paxil among pregnant women. Although there is no actual controlled study showing the effects of Paxil on a developing baby, some evidence has showed dangers can occur more often when Paxil is taken in later stages of the pregnancy.

In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil. As a consequence of these studies, GlaxoSmithKline and the FDA reclassified Paxil as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown that the drug poses a risk to the fetus.

Health Canada warned in August 2004 that Paxil during late pregnancy might be putting babies at risk after international and Canadian reports indicated some newborns, especially if the mother used a newer antidepressant like Paxil during the final three months of pregnancy, developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding.

The reported symptoms in the babies included feeding and/or breathing difficulties, seizures, muscle rigidity, jitters and constant crying. Since there is also a lack of information regarding the safety of breastfeeding while taking Paxil, many women and obstetricians are frustrated with the lack of guidelines available to make informed decisions.

Paxil heart defects in infants

In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil. As a consequence of these studies, GlaxoSmithKline and the FDA reclassified Paxil as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown that the drug poses a risk to the fetus.

Researchers have been concerned about selective serotonin reuptake inhibitors (SSRIs)—Paxil is in this category—on fetuses for some time, but the FDA's announcement now indicates significant risk, particularly since a large number of pregnant women (estimated as high as 20 percent) suffer from depression and are readily prescribed antidepressants, including Paxil.

The most common Paxil heart problem birth defect is ventricular septal defect (VSD). VSD is a heart problem in where a hole develops between the right and left pumping chambers of the heart. Babies with large VSDs will do well the first few weeks after birth; however, if the VSD heart problem is left untreated it will become dangerous and can lead to congestive heart failure.

VSD is the most common infant heart problem, occurring in 0.1% to 0.4% of all births. VSD makes up 20–30% of all infant heart problems.

The signs of VSD heart problems in a child include:

    * Abnormal growth

    * Lower energy levels compared to children the same age

    * Difficulty Eating

Medication can be used to cure VSD and a feeding tube may be needed to assist eating. Surgery may be necessary to close the hole if the medication is not properly working.

Atrial Septal Defect (ASD) is a heart problem where a hole develops between the two upper chambers of the heart. The hole may eventually close but many times it needs to be surgically repaired. An ASD heart problem may be diagnosed at birth but very often ASD symptoms will not be realized until the person is in their 20s, 30s and even their 40s.

ASD symptoms in infants include poor appetite, abnormal growth, and signs of heart failure. Adult ASD heart problem symptoms include:

    * Shortness of breath

    * Fatigue

    * Swelling of legs, feet, or abdomen

    * Excessive heart beating.

Large ASDs also increase the risk of other heart problems, including heart attacks and stroke.

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Paxil and mental health

Paxil has many dangerous side effects related to specific mental disabilities.  A recent study outlines some of the most common side effects by diagnosed disorder:

Major Depressive Disorder

The most commonly observed adverse events associated with the use of Paxil were: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

Obsessive Compulsive Disorder

The most commonly observed adverse events associated with the use of Paxil were: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

Panic Disorder

The most commonly observed adverse events associated with the use of Paxil were: Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

Social Anxiety Disorder

The most commonly observed adverse events associated with the use of Paxil were: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawning, abnormal ejaculation, female genital disorders, and impotence.

Generalized Anxiety Disorder

The most commonly observed adverse events associated with the use of Paxil were: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

Posttraumatic Stress Disorder

The most commonly observed adverse events associated with the use of Paxil were: Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Paxil physical addictions

Paxil is also associated with withdrawal symptoms that could occur when dosages are dramatically decreased or patients are discontinuing treatment. It is estimated that approximately four to ten percent of Paxil users will experience extreme adverse Paxil withdrawal symptoms, though others may experience more mild Paxil withdrawal symptoms.

The onset of Paxil withdrawal symptoms usually occurs between one to three days following the discontinuation of treatment and can last for many months in more severe cases. A period of two to six weeks is the average time patients experience Paxil withdrawal symptoms. For some people, the symptoms of Paxil withdrawal are among the most horrifying experiences imaginable.

If you are diagnosed as suffering from withdrawals that may be linked with your use of Paxil, contact the Paxil attorneys at the Ammons law firm now.

The pain and nausea some people feel when they stop taking certain antidepressants is spurring controversy over whether these drugs should carry explicit warning labels about withdrawal.

Your Claim

Paxil was approved by the FDA for treating depression, obsessive-compulsive disorder, panic disorder, and social anxiety disorder in 1992. The FDA later approved the use of Paxil for treatment of posttraumatic stress disorder, in 2001. At that time, however, the FDA also required that Paxil’s manufacturer increase the level of warnings to deal with the fact that the manufacturer had never adequately warned of the serious side effects many people suffered when attempting to withdraw from Paxil. In fact, Paxil had, at that point, been marketed for years as being non-habit forming when, in fact, many patients continued to use it simply to avoid the severe withdrawal symptoms.

If you or your loved one suffered serious side effects from withdrawal or were unable to discontinue using Paxil, you may have a case against the manufacturer for not sharing with you this information. Depending on when you started taking Paxil, you may also have a case against your doctor if, in fact, the warnings had been changed before you started taking Paxil and your doctor never adequately warned you about the problems with withdrawing from Paxil.

If your child suffered from birth defects or persistent pulmonary hypertension (PPHN) after the mother took Paxil during pregnancy, you may have a cause of action against the manufacturer for failing to adequately warn you or against the treating doctor for not warning about the dangers of using Paxil during pregnancy.

Another issue arises in that the FDA never approved Paxil for use in treating depression and other mental disorders in children. Nonetheless, Paxil’s manufacturer promoted the use of Paxil for children for many years. Paxil does not appear to adequately treat children suffering from depression. In addition, the use of Paxil has been linked to increased suicidal tendencies in children and adolescents. If your child used Paxil and attempted or committed suicide, you probably have a cause of action for damages against the manufacturer. You may also have a cause of action against your child’s doctor. Although Paxil was promoted as helping children, the FDA did not approve it for that use and your child’s doctor should have been aware of that.

Finally, Paxil has been linked with increased suicidal and homicidal tendencies in adults. Again, this appears to be a tendency that the manufacturer was aware of but chose to downplay or ignore. If your loved one committed or attempted suicide while taking Paxil, you may have a claim against the manufacturer.

If you have suffered harm from taking Paxil, call an experienced Paxil attorney at the Ammons law firm today.

Settlements

GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to court records.

The London-based company hasn’t disclosed the settlement total in company filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), according to its latest annual report. This included all legal matters, not just Paxil.

The drugmaker has reduced its insurance coverage to contain costs, “accepting a greater degree of uninsured exposure,” the annual report states. “Recent insurance loss experience, including pharmaceutical product-liability exposures, has increased the cost of, and narrowed the coverage afforded by, insurance for pharmaceutical companies generally,” Glaxo said.

Paxil Is Different

Experts say the fact that Glaxo has had three major personal injury litigations over one drug, Paxil- the suicide, the birth defect and the withdrawal cases is really unusual.

The company had $11.7 billion in U.S. Paxil sales for nine years starting in 1997, according to documents made public this year in a Pennsylvania trial. In 2002, the year before Paxil faced generic competition in the U.S., sales of the drug there were $2.12 billion. Last year, U.S. sales had fallen to $129 million. Through September of this year, sales were $52 million, down 52 percent from the same period in 2008.

Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil users were subjected to an undisclosed, higher risk for suicide and birth defects.

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