Zoloft Depression

Friend’s behavior feels threatening

July 30, 2006

Q: I’m 15 and an avid reader of your column. I really hope you can help me on this. My friend “Ann” and I are a year apart in age and have been friends ever since our little sisters became friends. We are very artistic and have always gotten along very well.

However, two big problems have arisen between the two of us. A while ago, Ann’s parent’s split and now they live apart. Plus, her mother was (and is still) dating an Ashton Kutcher look-alike who is about 10 years younger. Ann was very broken up and tried to commit suicide. Afterward, she was prescribed Zoloft for depression.

Not soon after Ann professed love toward me. This startled me, but I don’t like her that way and I told her so. Since then, she has been very distant and gets jealous or angry when I talk to or hang with other people. She is moody, violent and cruel to the people I hang out with. Every little problem she has is made larger than life and everything gets blown out of proportion.

I’ve tried to confront her, but every time I do she tunes me out. When I get angry, she starts going off about how I hate her or how our relationship is only based on pity. I love Ann and she’s like a little sister to me. But I love the rest of my friends, too, and I’m tired of her getting angry with me for having them.

I think what I need is a break from her — but how do I tell her that? How do I tell her that she has made me so angry that I just want her to let me be for a while? What am I supposed to do?

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A Ann’s life sounds as if it is spinning out of control and you are being pulled into the middle of all her emotional chaos. When people experience an emotional trauma, such as parents going through a divorce, they tend to cling to those who feel safe. And those they cling to often are left feeling smothered and overwhelmed.

While their biggest fear is being rejected again, they create situations where other people feel forced to create distance due to their unstable behaviors. It sounds as if you have been empathetic to Ann but now you are putting up a healthy boundary that needs to be established. Do you know if Ann is in therapy? Depending on who prescribed the Zoloft, she may or may not be talking with a professional. If she is not, take one of your parents and go talk to one of Ann’s parents. Tell them you have concerns about some of Ann’s behaviors and you hope they get her into counseling immediately. Let them know you care for Ann but she is harassing you and your friends. Give examples of strange behaviors she has shown so they get the idea and can share these with the therapist. Will Ann be angry with you for doing this? Perhaps. Is it needed for both her mental well-being as well as yours? Absolutely.

If Ann is in counseling, set firm boundaries when you have any contact with her. Let her know that you will not tolerate mean behavior toward you or your friends. Tell her that if she can’t agree to being nonconfrontational and nice, you can’t agree to hanging out with her. Leave the choice up to her and hold hard to the expectation that she show you respect when hanging out with her.

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Paxil Birth Defect Lawsuit Filed For Child With Severe Heart Defects

July 28, 2006

Child Born with Severe Heart Birth Defects Sues Paxil-Maker

Two-year-old Adrian Vasquez has undergone three open-heart surgeries and now has a pacemaker. His mother took the antidepressant Paxil throughout her entire pregnancy.

Adrian and his parents, Anthony and Matilda Vasquez of Bedford, Texas, filed a lawsuit today against Philadelphia-based GlaxoSmithKline (”GSK”), the maker of Paxil, in Pennsylvania State Court. The family alleges that Mrs. Vasquez’s ingestion of Paxil during her pregnancy resulted in her son being born with severe heart defects. The Vasquez family is seeking an unspecified amount of damages against GSK for failing to warn about the risks associated with Paxil for pregnant women and their unborn children.

According to Baum Hedlund attorney Karen Barth Menzies, who represents the family: “Adrian Vasquez is a tough little boy. The trauma he has endured in his brief two years of life is much more than most of us will ever have to suffer in our entire lifetime. The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning. Over 1 percent — or 40,000 — pregnant women in the US are taking antidepressants. Given the popularity of Paxil, thousands of babies are at risk.”

During the last month of her pregnancy, Mrs. Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something very wrong with her baby’s heart. When Adrian was born a few weeks later, on April 19, 2004, in Norfolk, Virginia, he had several life-threatening congenital heart defects. His parents were repeatedly told that his chances of survival were low.

During the first year of his life, Adrian underwent three open-heart surgeries (at eight days, five months and 10 months) due to his heart defects. He also underwent at least four cardiac catheterizations, and at least thirty echocardiograms within the first few months of his life.
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Adrian is now two years old and, while he is behind in his verbal and motor skills, his health has improved. Adrian will, however, need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear. [See Fact Sheet for more information about the Vasquez family.]

The Vasquez family is represented by Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, D.C. and Philadelphia. [See Fact Sheet for more information about Baum Hedlund.]

In 2003, GSK initiated a retrospective analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of their pregnancies and had given birth to children with major congenital malformations. The analysis showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants.

Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005, also found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.

In September 2005, GSK sent out a “Dear Doctor” letter informing physicians throughout the United States that the results of its analysis showed a higher rate of “congenital malformations associated with the use of Paxil as compared to other antidepressants” in infants born to women taking antidepressants during the first trimester of pregnancy. The most common malformations for mothers taking Paxil were cardiovascular, particularly ventricular septal defects (”VSD”).

The FDA has issued three Public Health Advisories since December 2005 concerning the risk of congenital heart defects and has changed Paxil’s pregnancy category from C to D, which indicates that “[t]here is positive evidence of fetal risk.” [See Fact Sheet for more information.]

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A new survey of Food and Drug Administration scientists finds wide ranging and disturbing problems throughout the agency.

July 28, 2006

On August 6, 2003, Timothy “Woody” Witczak went out to his garage and hung himself from a rafter. The 37-year-old, who had no history of depression, had been prescribed the antidepressant Zoloft to treat the insomnia he had experienced since starting a new job.

Neither Woody nor his family were warned that one of Zoloft’s reported side-effects was suicidal behavior, despite the fact that for more than a decade, both Pfizer, the company that produces the drug, and the Food and Drug Administration had been aware of suicidal incidents linked to antidepressant use. In 2004, the FDA actually prevented one of its scientists from revealing the correlation to the House Energy and Commerce Subcommittee on Oversight.

Combined with the now infamous political intervention that stymied the approval process for the potentially over-the-counter morning-after pill Plan B, and the failure of the FDA to act in a timely manner in the Vioxx and Celebrex cases, it’s apparent that the agency is failing in its responsibility to regulate the products that account for 25 cents of every consumer dollar spent in the US.

Last week, the Union of Concerned Scientists released the results of an anonymous survey sent to 5,918 FDA scientists (of which, nearly 1,000 responded) that helps give a full picture of the dysfunction.

The researchers’ answers portray a culture of discontent where scientists report not having enough resources to properly evaluate products, having scientific results ignored, being pressured by political appointees to approve drugs and–most criminal, considering the FDA’s mission–providing misleading information to the public.

The survey’s critics, led by FDA spokeswoman Susan Bro, argue that its questions were leading and unscientific. But what they cannot refute is the 69 pages of scientist-penned essays, which clearly describe some of the agency’s most disgusting practices: “They just take you off the product review if they don’t like your opinion,” was one common refrain. The scientists also reveal that “decisions are influenced by industry lobbying and political pressure,” and that a division Deputy Director would approve “a drug, regardless of the medical and statistical review, without ever looking at the data.”

In recent years, the FDA has been consistent in its denial of serious internal problems. In 2004, safety officer David Graham–who blew the whistle on Vioxx–testified in the Senate that the agency was unable to keep drugs that officers felt were unsafe off the market. Naturally, FDA officials refuted Graham’s testimony, labeling it “inaccurate” and “unscientific.”

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Vaccine drives Wyeth’s income, earnings

July 20, 2006

Wyeth’s second quarter net income climbed 9 percent, driven by a 60 percent sales surge for Prevnar after the pneumonia and meningitis vaccine was added to national immunization programs in Europe.Earnings rose for a fourth straight quarter to $1.1 billion, or 78 cents a share, from $976 million, or 72 cents, a year earlier, the Madison, New Jersey-based company said today in a statement. Revenue increased 9.4 percent to $5.2 billion, the drugmaker said.

Wyeth’s earnings beat analyst estimates by two cents as global pharmaceutical sales rose 11 percent. Prevnar generated $518 million, sales of the Enbrel arthritis drug jumped 36 percent and Effexor, the company’s biggest-seller, were up 3 percent. Some analysts expressed concern Effexor sales may slow on generic competition and new drug approvals may be delayed because of defects at a company plant.

‘’Wyeth still benefits from an absence of generic competition which many of their competitors face right now,” said Barbara Ryan, an analyst with Deutsche Bank in Greenwich,

Connecticut, in a telephone interview today. ‘’There is nothing surprising here. In the short run, though, they are in the midst of some problems at their plant in Puerto Rico that may delay further progress in new drug approvals.”‘ Wyeth’s second-quarter profit beat the average estimates of 20 analysts surveyed by Thomson Financial by two cents. Thomson declined to disclose the basis for the projections.

Shares

Wyeth shares rose 38 cents to $44.71 at 9:31 a.m. in New York Stock Exchange composite trading. The stock has fallen 3.8 percent this year, falling short of a 1 percent rise in the Standard & Poor’s 500 Index.

Sales of Effexor, the world’s best selling antidepressant, were $918 million in the quarter, while Enbrel, which treats rheumatoid arthritis, generated $370 million, the company said.

Protonix, a treatment for severe heartburn, had revenue of $441 million, a 3 percent decrease.

Wyeth raised its annual earnings guidance last week to more than $3.07 a share from the previous estimate of $2.97 to $3.07 a share, citing an expected increase in sales for the quarter.

‘’A lot of growth this quarter was driven by our biotech products,” said Chief Executive Officer Robert Essner in an interview on CNBC today. ‘’Enbrel and the vaccine Prevnar were the engines that drove us.”

New Applications

Wyeth also said it filed two new drug applications in the quarter to treat post-menopausal women. The company’s bazedoxifene would treat the bone-thinning disorder osteoporosis and desvenlafaxine is for hot flashes and night sweats.

Consumer health revenue was unchanged at $598 million.

Sales of Robitussin, Dimetapp, and Advil Cold & Sinus fell as retailers restricted sales of products containing pseudophedrine, the main ingredient used to make the street drug methamphetamine, or crystal meth.

Reduced revenue from those cold medications was offset by increased sales of Advil and the multivitamin Centrum, the company said.

Last week, Wyeth said in a call with analysts that it is working with U.S. regulators to fix problems at its Puerto Rico plant. The plant must pass inspection before its Lybrel birth control drug will be approved. In one instance, federal investigators found a screw and two washers in a bottle of a blood-pressure medicine.

‘Manageable Situation’

‘’The focus with earnings is on getting an update on the situation with the Puerto Rico manufacturing facility,” said Chris Shibutani, a JP Morgan analyst in New York, in a telephone interview yesterday. ‘’Is this manageable, should we be concerned with any of the issues there affecting the pipeline?”

Two days ago, Forest Laboratories reported a 15 percent rise in quarterly sales for its antidepressant Lexapro and the company’s shares fell on concern about competition from generic Zoloft, a Pfizer Inc. drug that lost patent protection June 30.

Two generic-drug makers have received approval to sell Zoloft copies and are expected to start shortly.

Although Effexor is a different formulation than Zoloft, health insurers will likely be encouraging doctors and patients to use generic Zoloft first to treat depression because of the cost savings, said Gary Nachman, an analyst with Leerink Swann & Co. in New York.

‘’It absolutely could have an impact on the whole class of drugs,” Nachman said in a telephone interview yesterday.

The company’s 5 1/2 percent note maturing in February 2016 rose 29 cents on the dollar to 96.16 cents on the dollar, and the yield rose 6.03 percent, according to Trace, the bond price reporting system of the National Association of Securities Dealers.

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Depression Hurts! I Know Because I’ve Been There

July 19, 2006

I suffer from the classic version of depression . I started with bouts of it when I was seventeen, but it wasn’t until my late thirties or early forties that it got so bad that I had to seek help. Over the years doctors prescribed Zoloft, Prozac, Paxil, Lexapro, and Wellbutrin.I got a little relief, but the pills made me so tired all I could do was lay around and then I put on weight, which made me more depressed. So I decided to try a natural approach.

Here are the steps to recover from depression - these are the same steps that I have used:

1) I can’t stress this one enough. Drink WATER, WATER, WATER, and more WATER! Drink approximately half your weight in water in ounces each day. (ex: If you weigh 150 pounds you need to drink 75 ounces of water a day). Your water should be bottled or filtered water.

If you are a soda drinker, cut back, better yet, quit drinking that STUFF! If you are a soda drinker, start using soda as a special treat. When I was growing up in the mountains of West Virginia. We only made it to the grocery store a couple times a month, but when we did go we were allowed to get a bottle of coke. What a treat, and that’s the way it should be. It has no nutritional value and only makes you fat.

Do not and I repeat do not drink diet soda. I have done research on the artificial sweeteners that they use and have found information that artificial sweeteners can cause brain tumors. Soda is a tough one for me, because I love Cocoa Cola, so if I do drink a soda I drink regular. If you are a coffee drinker, drink your one cup in the morning to get you going then no more the rest of the day.

2) Use a natural anti-depressant. I have used prescription anti-depressants and as I said before, I did get a little relief from my symptoms but I gained thirty pounds on the prescription drugs, which made me more depressed because of the weight gain. I gained more weight than when I was pregnant. There are a lot of side effects to consider when you take prescription drugs. I do not want to have to worry about the side effects on top of my illness.

Make sure the ingredients are herbs for depression. I’ve tried a lot and some work, some don’t. Unfortunately I have found there is no magic pill. It’s pretty much trial and error, as everyone’s body chemistry differs. I take them still and my husband says I’m a whole lot nicer to be around and I have a lot more energy. My spurts of anger and mood swings have all but vanished. Something that my husband is very happy to see gone! He’ll even remind me to take them, less I forget!!

3) Use good Multi Vitamin Supplements.Don’t buy these at department stores,but instead buy them from a store that specializes in natural vitamin supplements or online from a reputable company. I buy mine from the company in the above link but there are a lot of good online companies. Just make sure they’re natural and have been tested.

4) Other vitamins and supplements that you need are a good fish oil supplement that has your Omega Oils. You can also buy a Flax seed oil that has the omega’s in it.

5) Eat a good healthy diet. I will tell you here to start using as many natural and organic products as possible. All of the chemicals that they put in our food are making us sick. Try to buy meat that is organic or has not been injected with hormones and chemicals. We women are already having to deal with our own unbalanced hormones. We do not need the ones that they give to the cows and other animals in our system making things worse.

Try to get vegetables and fruits that are organic. If you can’t afford organic, buy a fruit and vegetable wash that removes the wax and chemicals from the produce. Try to eat the deep colored fruits and vegetables they have more of the good nutrients in them.

6) Exercise. This is a hard one. When you are depressed, the last thing you have is energy to exercise, but you need to exercise to get your energy back. A catch 22. Start out slowly, even if it is only a ten minute walk or ten minutes on your treadmill. Something is better than nothing.

7) If you are a woman and are near menopause, use a Natural Progesterone Cream. I am 44 and use one. There are a lot of god ones out there but make sure it’s natural and not synthetic. I have noticed that my mood swings have subsided and no more hot flashes, but it does take about three months of using the cream to get results.

When you suffer from depression, it is a tremendous battle, but it is one worth fighting. My family had to put up with so much during my severe bouts of it. Depression hurts your relationships. I would get mean and say hurtful things, then cry all the time. I would spend weeks in bed at a time. On my good days I work, read, and do research about depression. I hope that my information will help you. It may take some time, but you will get a handle on it and if you treat it with natural products, a healthy diet, pure water, and exercise, you will be able to keep a handle on it.

Remember, if depression hurts you depression hurts everyone around you!

So please seek depression treatment and help

Diana is a Natural Health Consultant, Weight Loss Specialist, Personal Trainer, Mental Skills Training Specialist and author of the Natural Health and Herbal Remedies website. She has gone thru depression, pms, perimenopause, weight loss issues, anxiety attacks, and more but has learned how to control them through natural approaches.

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Forest Labs Seen With Industry-Best Balance Sheet

July 15, 2006

Investors who bought shares of Forest Laboratories ahead of a pivotal court ruling were rewarded on Friday after the company said it has won a key patent dispute.

A federal court judge in Delaware ruled that Forest’s patent for depression drug Lexapro was valid and has therefore been infringed upon by Teva Pharmaceutical Industries‘ generic version, Forest said in a release. The patent will expire in 2012.

Forest shares jumped more than 14% in afternoon trading Friday.

Lazard Capital Markets analyst Megan Murphy said the ruling removes a “significant overhang” on the stock and will likely refocus attention on Forest’s drug development pipeline.

“Thus far, management is doing what is necessary to build out its pipeline,” Murphy wrote in a research report Friday. “It has bought back nearly 20% of the company and has, arguably, the best balance sheet in the space.”

The analyst maintained a “buy” rating and $55 price target on the stock and said a number of potentially positive events could be in store for Forest in the next six to 12 months.

“The favorable ruling on the Lexapro patent resolved the largest risk to the shares,” she noted. “We will monitor the impact of generic Zoloft on Lexapro scripts starting in mid-July. In addition, a Nebivolol resubmission is possible by year-end. There is the potential for additional licensing deals.”

Meanwhile, Banc of America Securities maintained a “neutral” rating and said the looming patent expiration of Pfizer’s Zoloft could pressure Lexapro sales.

“With the Lexapro patent risk out of the way, we expect a lessening of the Forest share discount,” wrote analyst David Maris. “However, we continue to see some fundamental risks, which will likely maintain a discount to peers.”

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Daily Women’s Health Policy

July 12, 2006

Most of the 13 physicians who co-authored a study regarding depression relapse risk for women who stop taking their medication during pregnancy — published in the Feb. 1 edition of the Journal of the American Medical Association — did not disclose more than 60 financial relationships to pharmaceutical companies, the Wall Street Journal reports (Armstrong, Wall Street Journal, 7/11). The study, funded by the National Institute of Mental Health, questions the commonly held belief that hormones produced during pregnancy protect women from depression. Lee Cohen, director of Massachusetts General Hospital’s Center for Women’s Mental Health, and colleagues between 1999 and 2003 monitored 201 pregnant women with a history of depression. The women were taking medications such as Prozac, Zoloft, Effexor and Paxil. Researchers found that 68% of the women who stopped taking antidepressants relapsed into depression during pregnancy. In addition, 26% of the women who continued taking their medication during pregnancy also became depressed (Kaiser Daily Women’s Health Policy Report, 2/2). According to the Journal, the study did not disclose that Cohen is a consultant to three pharmaceutical companies and a paid speaker for seven drugmakers or that some of his research is funded by four such companies. The second listed author of the study — Lori Altshuler, director of the Mood Disorders Research Program at the University of California-Los Angeles — is a consultant or speaker for at least five drug companies, affiliations that were not disclosed. Adele Viguera, associate director of MGH’s perinatal psychiatry program and co-author of the study, did not disclose that she is a member of GlaxoSmithKline’s speakers bureau. The study did disclose the financial ties to drug companies of two of the authors, Zachary Stowe and Jeffrey Newport of Emory University. Previous Studies
The study is the first major research paper to establish a relapse risk for pregnant women who stop taking antidepressants, the Journal reports. Previous studies have questioned the safety of antidepressant use during pregnancy. One study found an increased risk of an infant experiencing a potentially fatal lung disorder if the woman takes a group of antidepressants called selective serotonin reuptake inhibitors during pregnancy, and two other studies found that use of GSK’s Paxil during pregnancy could cause cardiac fetal heart defects. The results of those studies are being called into question by industry-paid experts in the field, according to the Journal.

JAMA, Authors’ Reactions
JAMA said that its policy requires study authors to disclose all ties to the medical industry, the Journal reports. JAMA editor-in-chief Catherine DeAngelis said the journal was not aware of the relationships some of the study’s authors had with drug companies, and “[a]s soon as JAMA found out that they didn’t disclose, we contacted … Cohen and asked for his explanation.” She added, “We have one and it will be published very soon in an upcoming issue of JAMA.” According to the Journal, the researchers “maintain that their financial links have no bearing on their research work or what they say about antidepressant use during pregnancy in interviews or lectures.” Cohen said that “it didn’t seem relevant” for him and other co-authors to disclose their financial ties in part because the study was funded by a federal health agency. He declined to describe his consulting role to drug companies or how much he is paid for the role, but he did say that drug companies “tend to pick people who are experts in this area” and “we are not talking about megabucks.” Viguera said that because of the way the study was designed, he does not “see how any kind of relationship [the researchers] have with a pharmaceutical company plays a role in that.” He added, “I don’t believe there is a conflict of interest.”

Other Reaction
According to the Journal, “industry-paid opinion leaders have become dominant authorities” in the field of antidepressant use during pregnancy, and they often assist in developing clinical guidelines, are members of journal editorial boards, provide counsel to government agencies and teach courses to other physicians. “Whether or not to keep taking an antidepressant during pregnancy is a critical question for pregnant women suffering from depression,” Adam Urato, a Bradenton, Fla.-based obstetrician and perinatologist who has questioned Cohen and his colleagues about their financial ties, said, adding, “What these pregnant women and the providers who care for them need is expert advice that is free from pharmaceutical industry influence or the suggestion of bias that results when these experts are being paid by many antidepressant manufacturers.” A Pfizer spokesperson said, “It is important to remember that this is a partnership with the mutual goal of advancing science and enhancing patient care.” Nada Stotland, a professor of obstetrics and psychiatry at Rush Medical College in Chicago, said pharmaceutical companies have the resources needed to fill a research void on the effects of antidepressants during pregnancy, but they often “only do what they are required to do” by FDA. She added that there are few studies that examine the effects of antidepressant alternatives, such as psychotherapy, on treating depression among pregnant women. Alan Gelenberg, head of the psychiatry department of the and editor of the Journal of Clinical Psychiatry, said less than 5% of his income comes from consulting work with pharmaceutical companies, adding, “The problem is if you want an expert on antidepressants in pregnancy, most of us have taken some industry money.” Gelenberg said the answer to industry-funded experts is increased funding from government and independent sources

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