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ANTIDEPRESSANTS ALTHOUGH THESE POWERFUL DRUGS SERVE A USEFUL PURPOSE, THEIR EXTREMELY SERIOUS SIDE-EFFECTS MUST NEVER BE MINIMIZED ZYPREXA SETTLEMENT UPDATE INFORMATION INCLUDEDJun 1, 2005 Introduction
When Prozac was approved by the FDA in 1988, it immediately gave hope to millions of people who suffered from depression. As a result of the drug’s incredible success, there was a race to develop and approve other powerful drugs to treat the symptoms of depression, anxiety, schizophrenia, dementia, and other serious psychological disorders.
Although there now seems to be a drug for every psychological problem, concerns over the safety of these drugs have been steadily growing with respect to both adults and children. Many experts say that the benefits of antidepressants clearly outweigh the risks and people who legitimately need them should have access to them. Others argue that these powerful drugs are being over-prescribed especially to teenagers and children with disastrous results. Critics also claim that these drugs are being unnecessarily prescribed to patients with only mild or borderline-moderate depression.
The information in this Newsletter pertains primarily to the antidepressants Prozac, Paxil, Zoloft, Zyprexa, Effexor, Serzone, Wellbutrin, Lexapro, and Seroquel. (Serzone was removed from the U.S. market in May 2004 after being linked to 26 deaths from liver damage.)
If you are currently taking an antidepressant and have any concerns about the safety or side effects of the drug you should consult your physician immediately. Since there are risks associated with the sudden withdrawal from many of these drugs, you should only stop taking them under medical supervision.
Antidepressants are approved to treat depression and sometimes depression can include preexisting suicidal tendencies. However, new studies have shown that some antidepressants may actually raise the risk of suicide. A large-scale study of 702 controlled clinical trials involving 87,650 patients helped to shed light on the suicide risk by looking at patients being treated for a variety of conditions such as sexual dysfunction, bulimia, panic disorder, and depression.
The examination of these trials indicated that adults taking popular antidepressants such as Prozac, Paxil, and Zoloft are more than twice as likely to attempt suicide patients in the placebo groups.
This study, conducted by Dr. Dean Fergusson, an epidemiologist, and his colleagues at the Ottawa Health Institute, is considered to be a breakthrough as it examined patients receiving treatment for a variety of conditions. There was evidence of an increased risk of suicide attempts for patients with various psychological disorders including depression.
In an interview, Dr. Fergusson said: “The biggest concern is these drugs are widely prescribed. There are millions of people on the drugs, so even a risk of one in a 1,000 when you amplify it to the millions, it becomes a public health issue.”
The increased suicide risk does not only apply to adults. Studies released prior to the Ottawa Health Institute study indicated that some antidepressants, specifically Prozac, may actually cause an increased risk of suicide or attempted suicide in children and teenagers. There have been several court cases in the last five years relating to suicidal or violent behavior carried out by children or adolescents who were placed on anti-depressants. While Prozac has been approved for treatment in children and adolescents, parents must be extremely cautious when considering any antidepressant as an option for a child younger than 18.
To understand the extent of the risks and precautions associated with antidepressants, one need only read the follow excerpts from the patient handout for Wellbutrin XL and SR:
SIDE EFFECTS: Dry mouth, nausea, vomiting, stomach/abdominal pain, flushing, headache/migraine, loss of appetite, trouble sleeping, increased sweating, strange taste in mouth, weakness, drowsiness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, fainting, chest pain, fast heartbeat, severe headache, tremor, unusual weight loss or gain, ringing in the ears, mental/mood changes (e.g., hallucinations, anxiety, nervousness, agitation, confusion, restlessness), decreased sex drive, difficulty urinating.
Seek immediate medical attention if the following infrequent but serious side effect occurs: seizures.
Bupropion should be stopped permanently if you have a seizure during treatment.
An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing, muscle aches, joint pain, fever.
This medication should not be used if you are suddenly stopping regular use of sedatives (e.g., benzodiazepines such as diazepam) or alcohol, which can cause a higher risk of seizures.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: head injury, brain tumor, liver problems, heart problems, high blood pressure, kidney problems, any mental conditions, diabetes, alcohol/drug dependence, intention to quit smoking.
This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery.
Limit or avoid consumption of alcoholic beverages. Alcohol can increase your risk of seizures.
Do not take this medicine with any other product containing bupropion (e.g., drugs to help quit smoking) since large doses of bupropion are more likely to cause seizures.
Though uncommon, depression can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, worsening depression, or any other mental/mood changes (including new or worsening anxiety, agitation, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, rapid speech). Keep all medical appointments so your healthcare professional can monitor your progress closely and adjust/change your medication if needed.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
If this medication is used during the last 3 months of pregnancy, infrequently your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness, or constant crying. However, do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor promptly.
Bupropion passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug.
Newborns and Elderly Patients
A recent study published in the Journal of the American Medical Association (JAMA) indicated that women who take Prozac or certain other antidepressants late in pregnancy raise the risk that their babies will suffer jitteriness, irritability, and serious respiratory problems during their first couple of weeks. (See Wellbutrin patient handout above.)
The drugs in question include Prozac, Paxil, and other antidepressants that belong to a group known as selective serotonin re-uptake inhibitors (SSRIs), and also Effexor, serotonin norepinephrine reuptake inhibitors. (Wellbutrin, an antidepressant of the aminoketone class is not an SSRI yet these same risks exist.) At least 80,000 women yearly take these drugs during pregnancy. Doctors are now saying that women may want to take a closer look at these risks before continuing or beginning treatment with an antidepressant during pregnancy.
Elderly patients with dementia taking certain anti-psychotic drugs were significantly more likely to die prematurely. The FDA is asking manufacturers of atypical anti-psychotic drugs to add a warning noting these risks.
An analysis of 17 studies covering several drugs including Seroquel and Risperdel showed the rate of death for the elderly patients taking these types of drugs was about 1.6 to 1.7 times the rate of death for placebo users.
Antidepressants in the SSRI group can cause internal bleeding. A study of 549 patients admitted to hospitals for acute gastrointestinal bleeding found that continuing use of SSRI antidepressants caused a risk of bleeding similar to that caused by the habitual use of painkillers like aspirin, ibuprofen, and naproxen.
To put things in perspective, gastrointestinal bleeding from painkillers such as aspirin, ibuprofen, and naproxen, known as non-steroidal anti-inflammatory drugs, has been blamed for 16,000 deaths per year in the United States.
Zyprexa and Zyrtec Mix-up
ZyPREXA, manufactured by Eli Lilly, is a powerful drug used to treat depression, schizophrenia, and bipolar disorder. Recently, the FDA notified healthcare professionals of a number of serious dispensing or prescribing errors in which ZyPREXA and Zyrtec (an allergy medication marketed by Pfizer) have been mistakenly confused. This has lead to unnecessary adverse events including potential relapses in patients suffering from schizophrenia or bipolar disorder.
In October 2004, the FDA ordered pharmaceutical companies to add strong warnings to antidepressants saying that these drugs could cause suicidal thoughts and actions in some children and teenagers. These “black-box” warnings accompany hundreds of drugs but in this case, the FDA also directed the manufacturers to distribute medication guides with every antidepressant prescription, a guide which is required for fewer than 30 drugs.
Children and teenagers taking antidepressants appear twice as likely to become suicidal than those in a placebo group. Yet the pharmaceutical companies and many medical experts maintain the overall risk of suicide is extremely low and for some, the benefits far outweigh the risk of side effects.
The black-box warning clearly states that “antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents.” The warning goes on to say that patients who are given the pills should be closely observed and notes that few antidepressants have proved effective against depression in children and teenagers.
The warning was added to several drugs including Prozac, Paxil, Zoloft, Effexor, and Wellbutrin. After the new warning labels were instituted, the number of children and adolescents using antidepressants fell significantly. There was a 10% decrease in prescriptions for patients 18 and younger in 2004 while there was an increase by almost the same amount in 2003. In fact, during the time period from 2000 to 2003, Medco Heath Solutions Inc. said that antidepressant use in children had jumped by 20% and use by preschoolers rose by 49%. This incredible increase was due to these antidepressants being used to treat attention-deficit hyperactivity disorder (ADHD), a use many experts believe was and is highly questionable and dangerous.
Diabetes – ZYPREXA SETTLEMENT UPDATE
Zyprexa, like two of the other antipsychotic drugs, Risperdal (Jannsen Pharmaceuticals) and Seroquel (AstraZeneca), has been found to cause serious side effects in patients, especially those who have already been diagnosed with diabetes and related illnesses. Knowledge of the dangers of Zyprexa was discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug. One of these cases resulted in death due to necrotizing pancreatitis, a condition in which cells in the pancreas die. In May 2003, forty additional reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.
An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug.
In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and other anti-psychotics and their link to the development diabetes6. The article estimated that somewhere around 11 million people have taken Zyprexa. An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died. Although the FDA was aware of these cases, it did not require Lilly (and the manufactures of similar antipsychotic drugs) to add a significant warning regarding these risks until September 2003.
Zyprexa has been prescribed to more than 17 million people worldwide since it was first marketed in 1996. It became Lilly’s best selling medication, after Prozac lost U.S. patent protection in 2001, with annual sales of $4.4 or almost 33% of Lilly’s total sales of $13.86 billion.
ZYPREXA SETTLMENT UPDATE
(Parker & Waichman in the News)
In a surprising move on June 9, Eli Lilly agreed to pay up to $690 million into a settlement fund designed to dispose of some 8,000 claims by patients who claimed that prior to September 2003, Lilly failed to adequately warn those taking Zyprexa of an increased risk of developing diabetes, hyperglycemia, and related illnesses thereby causing them to suffer a variety of related injuries.
While Lilly did not admit its best-selling drug caused the injuries in question, its potential exposure in the litigation far exceeded the settlement figure thus making this resolution of about 75% of the claims the company a prudent business decision.
Jerrold S. Parker, senior partner of Parker & Waichman, told reporters that: “It’s really remarkable to arrive at a settlement of this magnitude so far in advance of trial.” Mr. Parker said that the plaintiffs’ litigation team, made up of some of the foremost products liability attorneys, “was able to convince Lilly that plaintiffs’ case was a strong one, with a good likelihood of success, if it proceeded to trial. Parker & Waichman represents several plaintiffs in this litigation. More of Mr. Parker’s comments can be found at the online version of the Indianapolis Star at http://www.indystar.com/apps/pbcs.dll/article?AID=/20050610/BUSINESS/506100509 and at the online news service newsinferno.com at http://newsinferno.com/storypages/6-10-2005%7E001.html.
The fund will allocate compensation to the plaintiffs based primarily on the extent of their injuries which range from weight gain to death. The plaintiffs will be permitted to opt out of the settlement and pursue their claims individually.
Cases Many Experts Believe Are Linked to Antidepressants
While many argue the risk of suicide or violence towards others is not enough to prevent antidepressants from being prescribed, there many are families who have dealt with suicides or murders of loved ones which several experts believe were directly linked to the use of antidepressant medication.
• In the spring of 2005, teenager Jeff Weise shot nine people before shooting himself in what headlines called the worst school shooting rampage since Columbine. A debate ensued over whether his antidepressant, Prozac, rather than depression itself was the cause of this suicidal behavior towards himself and his classmates. Relatives say that doctors kept “upping” Weise’s dosage until as recently as three weeks prior to the shooting. Previously, Weise had been hospitalized for three days following an unsuccessful suicide attempt.
• In the late 1980s, when Prozac had just been approved by the FDA, Joseph Wesbecker shot and killed himself and eight others and wounded 12 while taking the medication. Wesbecker’s relatives sued manufacturer Eli Lilly for damages. Although the case was settled, it began to raise serious questions concerning the pre-approval research connected with Prozac.
• Former San Diego Deputy Sheriff Hank Adams shot his wife and himself to death in front of his seventeen-year-old daughter. Adams, who was taking Prozac, had no history of violence
• Rock and Roll legend Del Shannon (Charles Westover) was attempting a comeback in 1990. After seeing a psychiatrist, he committed suicide by shooting himself in the head with a .22 caliber rifle. He had been taking Prozac for 15 days.
• A 60-year-old man named Donald Schell began taking Paxil to treat depression. He took his first two pills before shooting and killing his wife, his daughter, his 9-month old granddaughter, and himself. Family members sued manufacturers GlaxoSmithKline and won a total of $6.4 million.
• In 2001, Christopher Pittman, 12, killed his grandparents. Despite his age, local prosecutors decided to try him as an adult and portray him as a troubled killer. The defense, however, claims that the killings occurred due to a reaction from his antidepressant, Zoloft, which Christopher had started taking not long before the incident. Although a jury rejected the defense, many experts believe there was a link between Zoloft and the killings.
The “Other” Side of the Controversy
Despite all the debate over the harmful side effects linked to the use of antidepressants, especially in young patients, a new study suggests that the lifesaving benefits of these drugs far outweigh the risks. This study, based on reviews of decades of data from Europe and the United States, revealed that there was a close correlation between a substantial decline in suicide and the initial approval of SSRIs.
Gail Griffiths of the FDA voted “yes” to the black-box warning for antidepressants. Now, however, she states that had she known that the warning would cause people to become fearful of antidepressants, she would have voted against the warning. Although Griffith’s son actually attempted suicide while on antidepressants, she still she believes that these drugs “are so often the life jacket preventing us from being sucked under by depression’s powerful undertow.”
A Recent “Discovery”
Eli Lilly received some bad publicity when it was revealed that original documents from pre-approval tests relating to Prozac which contained crucial information about side effects, such as suicidal behavior, had been missing for the past 11 years. New York Congressman Maurice Hinchey is currently reviewing these documents to determine whether Eli Lilly knowingly withheld important health and safety information from the public at the time of Prozac’s approval and subsequent market release. The FDA has agreed to review these documents that went “missing” during the controversial Joseph Wesbecker (above) products liability lawsuit.
A Marketing “Loophole”
Although a drug can only be marketed for specific indications endorsed by the FDA, federal law permits doctors to prescribe an FDA-approved drug for any use. This has led to many antidepressants being prescribed to children despite the fact that only Prozac has FDA approval to be marketed for that use. It has also led to all of the antidepressants being used to treat patients with disorders for which the drugs are not approved for marketing. Experts also argue that this loophole has led to over prescribing of antidepressants to patients with mild levels of psychological disorders for which the drugs were never intended.
Recently, the FDA rejected an application by Forest Laboratories to market the antidepressant Lexapro for the treatment of social anxiety disorder. An application to market Lexapro for panic disorder was previously rejected by the FDA. These rejections may prohibit Lexapro from being marketed for anxiety or panic disorders but it cannot prevent it from being prescribed for them. There are many critics of the FDA who see this as an anomaly which must be corrected in order to avoid potentially serious consequences to patients who believe a drug is approved for their illness simply because their doctor has prescribed it.
The debate over antidepressants is a complicated one because there is strong evidence on both sides of the argument. Clearly, many people with serious psychological disorders have been helped by these drugs to live happier, more stable, and more productive lives.
On the other side, however, is the very ominous possibility that the drugs are making many people (especially children) more suicidal and violent. Other serious side effects must also be considered by those taking the drugs.
One of the problems faced by medical experts is the difficulty in determining if some of the most serious behavioral problems associated with the drugs are truly caused by them or whether they are simply manifestations of the underlying disorder for which the drug was prescribed in the first place.
Eli Lilly has this to say about their best-selling antidepressant: “Prozac has helped to significantly improve millions of lives. It is one of the most studied drugs in the history of medicine, and has been prescribed for more than 50 million people worldwide. The safety and efficacy of Prozac is well studied, well documented, and well established.” Many highly qualified experts and critics of the drug would argue that, while this may technically be true, there is a dark side to the drug which makes its use a deadly game of Russian roulette.
Clearly, much more research is needed before either side can claim a clear-cut victory. As a result, antidepressants are certainly here to stay for the foreseeable future and they will continue to be prescribed to millions of people annually. If you or a loved one has been diagnosed with any disorder for which one of these drugs has been suggested, you should discuss the matter fully with your doctor. Be sure to ask about anything that is troubling you about the drug and do not be embarrassed to seek a second opinion. If you are already taking one of these drugs, be sure to watch for any possible side-effect or behavioral change especially any thoughts of suicide and report tem to your doctor immediately.
If you or a loved one has suffered any injury which you suspect may have been caused by one of these drugs you may contact Parker & Waichman at www.yourlawyer.com for a free case evaluation.