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Posted by john on July 6th, 2007 — in Paxil Top News
Generic drug developer Caraco Pharmaceutical Laboratories Ltd. said Tuesday the Food and Drug Administration granted final approval for a version of GlaxoSmithKline PLC’s antidepressant Paxil.
The FDA approved the Detroit-based company’s version, called paroxetine hydrochloride, which is indicated for the treatment of major depressive disorder, panic disorder, obsessive compulsive disorder, social anxiety disorder, generalized anxiety disorder and posttraumatic stress disorder.
Caraco offers 10-, 20-, 30- and 40-milligram strengths.
British drug maker GlaxoSmithKline (nyse: GSK - news - people ) booked 620 million pounds ($1.25 billion) in Paxil worldwide sales in 2006.
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GlaxoSmithKline’s patent on Paxil expired on June 29.
Shares of Caraco rose 33 cents, or 2.2 percent, to close at $15.62. Trading ended at 1 p.m. in an abbreviated session ahead of the July 4th holiday.
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Questions or comments about this story should be directed to reporter Jennifer Sterling at 212-621-7190.
Copyright 2007 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or
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Posted by john on July 2nd, 2007 — in Paxil Top News
Researchers from Boston University’s Slone Epidemiology Center have found that certain selective serotonin reuptake inhibitors antidepressants do not appear to increase the risk for most kinds of birth defects. The findings, published in the New England Journal of Medicine, suggest that individual SSRIs may increase the risk for some specific defects, but these are rare and the absolute risks are small.
The risk of birth defects following antenatal exposure to SSRIs remains controversial. Early studies demonstrated that SSRIs didn’t increase risks of birth defects when such defects were studied as a group. However, birth defects are not a single entity and individual defects have distinct causes. And, more recent studies have reported elevated risks for some birth defects.
Using data from the Slone Epidemiology Center’s Birth Defects Study, an ongoing program of case-control surveillance of medication use in relation to birth defects, the researchers considered relationships between first trimester SSRI use and the risk of various birth defects among mothers of 9,849 infants with birth defects and 5,860 infants without defects.
The researchers analyzed defects previously linked to SSRI use and found overall SSRI use was not associated with significantly increased risks of craniosynostosis (where connections between skull bones close prematurely), omphalocele (intestines or other abdominal organs protrude from the naval) or heart defects overall.
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Analysis of individual SSRIs and specific defects showed significant associations between setraline (e.g. Zoloft) and omphalocele and septal defects (defects in the walls that separate the chambers of the heart) and between the paroxetine (e.g. Paxil) and certain heart defects that interfere with blood flow to the lungs. This last association was also reported in another paper, from the CDC’s National Birth Defects Prevention Study, in this week’s NEJM. However, the BU researchers stress that even if a specific SSRI increased rates four-fold, as was observed for some of these associations, the risk of having an affected child would be less than one percent.
“Our analyses did not confirm previously reported associations between overall use of SSRIs and a number of birth defects,” said lead author Carol Louik, ScD, an assistant professor at the Slone Epidemiology Center at Boston University. “Rather our study suggests that risks are limited to specific SSRIs in relation to specific birth defects. Still, it is important to keep in perspective that the baseline risks for these rare defects are small, so even if the modest increased risks we observed are correct, the chances of having a child with such a defect are quite small,” she added.
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Posted by john on June 30th, 2007 — in Paxil Top News
Good news for expecting mothers who take drugs to fight depression. Two large new studies find that newborns face little risk of birth defects from their mothers who took antidepressants while pregnant, including Prozac, Paxil and Zoloft.
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The studies were launched over concerns about heart defects and lung problems. Researches still advise women to talk with their doctors.
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Posted by john on June 25th, 2007 — in Paxil Top News
MIAMI, June 25 /PRNewswire/ — For 40 million anxiety sufferers in the United States who do not respond well to traditional drugs such as Prozac and Paxil, there is now help to alleviate their distress without worrying about potentially dangerous side effects. This is especially welcome news for young children and teenagers who have had a higher incidence of suicide from taking anti-anxiety medication.
In a newly published study by the University of Miami School of Nursing in conjunction with The Sirkin Creative Living Center (SCLC), researchers found that using a natural remedy that is created from wildflowers has a comparable effect to the more traditional pharmaceutical drugs without any of the known adverse side effects including addiction.
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Dr. Robert Halberstein of the University of Miami states, “The results of our study indicate that this time-tested and safe product could be of great value to the general public.” Rescue(R) Remedy offers hope to millions of American anxiety sufferers. There is now scientific evidence for a natural option.
Bach(TM) Flower Rescue(R) Remedy (a homeopathic product) used in this study published in Complementary Health Practice Review, January, 2007, has been popular inside and outside of the medical community for more than 70 years. Commonly used in times of crisis, Rescue(R) Remedy rapidly relieves feelings of fear or panic, and reduces trauma or even post traumatic stress. The number one selling homeopathic remedy for stress relief in the US, “Rescue(R)” can be used by adults, children or infants.
The founder of SCLC, Alicia Sirkin, said “Because Rescue(R) Remedy sells over-the-counter anyone can buy it without a prescription. It belongs in everyone’s medicine cabinet.”
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Posted by john on June 23rd, 2007 — in Paxil Top News
How many ways can you describe a female tradie? On Mitre 10 Mega Jack of all Trades, the presenters outdid themselves. Pio introduced contestant Kirsten Drabble (previously seen on renovation show, Back to Basics) as a girl in his introduction. Later he said “Check the girl out.” Sigh. Where were you during the political correctness and sensitivity training? Later Wayne Take Your Shirt Off Bowden said she looked like she’d have a woman’s touch in the glue gun challenge.
Then presenter Jade Collins, who really should know better said she was the only chick in the contest, and then asked her how it feels to be the only lady in the contest. Later, Wayne and Jade both described her as having a woman’s touch. What happened to treating her like an equal?
By the first ad break Miss Prozac was praying that contestant Warwick Beckett would be eliminated for excessive brown-nosing. After the first challenge, backing the sponsor’s ute, Warwick was enthusing about how it was such a great vehicle to drive and gave the sponsor Mitsubishi a big plug. Despite Miss Prozac’s misgivings that Kirsten’s inclusion as a wild card contestant had more do to with ratings than skill Miss Prozac was praying she would demolish the sycophantic bootlicker and send him back to Taradale. She was also praying that one day Jade Collins would learn how to present and ask insightful, or at least original, interview questions. She’s improving but it seems her purpose is more decorative than informative.
Onto the carpentry and creativity in putting together a dog kennel and Miss Prozac was worried Warwick’s nose was getting sore after he etched sponsor Dulux’s name onto the top of the kennel. For heaven’s sakes. Then after the painting challenge he put a Dulux sign on top of the kennel – what a strange name for a dog. Can we give him penalty points for being such a tosser?
Kirsten’s kennel including a swing and her design skills saw her take out the kennel challenge and take the lead. Sadly after the bricklaying challenge Warwick nosed ahead and kept his snout in front for the remainder of the contest, even though Kirsten closed the gap during the demolition challenge. Time for the girl to go. Shame about that. She was the most exciting contestant to date. She had a big smile on her face and a great attitude. Or as Wayne Take Your Shirt Off Bowden said, it’s a shame to see her go because she was the
“Best looking thing here since sliced bread.” Well that’s not sexist.
Kirsten quipped, “Except you.”
“Goes without saying”, he replied.
Hooooo-kay. On that note we’ll leave it. We’re going to skip the next few shows. Miss Prozac has better things to do on a Saturday afternoon, but we’ll be back to review the final show on Saturday 28 July, 2007.
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Posted by john on June 17th, 2007 — in Paxil Top News
Dear Dr. Gott: I have a friend about whom I care deeply. He is an alcoholic. He is also going through a huge depression that has lasted for years. He doesn’t hold a steady job, so he has no health insurance or money. He won’t go to AA and said that he tried an antidepressant a long time ago when he had insurance, but it turned him into a zombie. Is there anything I can do to help?
Dear Reader: Your friend cannot be forced into getting the help he needs unless he is a risk to himself or to others. I recommend that you approach this delicate issue by sharing your concerns with him and offering your support. Other family members can also be involved in a meeting, called a crisis intervention, during which options are discussed openly.
There are two problems here: depression and alcohol abuse. Both need to be addressed with professional help. But first, your friend needs to admit he needs help.
If this approach is not successful, a more aggressive stance may be necessary, especially if he were to express suicidal thoughts while drunk. In this case, appropriate authorities should be informed so that your friend can avoid serious, consequences
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To help relieve your stress until the situation is resolved, make an appointment with your own physician, who can steer you to the appropriate community resources.
The last time I was involved in an identical circumstance, the crisis intervention involved the patient, his wife, four children, a social worker, six neighbors, a clergyman and me. We won out by sheer strength of numbers. The gentleman agreed to be seen in counseling, underwent therapy and stopped drinking. We were able to head off problems at the pass. He has turned his life around, and, despite an initial negative reaction to the intervention, he came to accept and be grateful for the support offered him. Good luck with a difficult problem.
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Posted by john on June 13th, 2007 — in Paxil Top News
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Q: I currently take Seroquel and Paxil for bipolar disorder and depression. I’m doing okay at the moment, but after reading a recent report of a study that stated that antidepressants are not effective in depression with bipolar disorder, I’m wondering if I should quit taking Paxil. Do you think I should stop it?
A: I wouldn’t upset the “apple cart” by stopping the Paxil and risking a destabilization of your mental health. The study to which you’re referring was published in the April 26, 2007 issue of the New England Journal of Medicine. They looked at whether there’s additional benefit to adding either Wellbutrin or Paxil in folks already receiving a mood stabilizer like Seroquel for the purpose of managing the depression seen in bipolar disease. To their surprise, although the addition of an antidepressant did not increase the risk of manic episodes, it did not help with relieving the depression.
Bipolar illness, also known as “manic-depression,” is a mood disorder with swings back and forth from a manic state to depression. During the manic state, one is filled with feelings of grandiosity; hyperactivity; distractibility; impatience and irritability; impulsivity; and a decreased need for sleep. This lasts for a few days to a few months, and then one “crashes” with a swing to the other extreme: depression, sluggishness, sadness, low self-esteem, hopelessness and withdrawal.
During this depressive phase, one may even feel suicidal. Then, within a few days to months, one begins to swing back toward the manic phase. Some folks are known as “rapid cyclers” and may change moods several times a day. The conclusion of that study is in debate for several reasons: 1) those with a past history of mania to any antidepressant were excluded from the study; and 2) the small size of the study group may have skewed the findings. While their findings did not show the benefit of adding an antidepressant, prior studies have suggested that there is benefit to using an antidepressant along with a mood stabilizer for depressant symptoms. Clearly, it would be a mistake to withhold or cease the use of an antidepressant in a depressed person based solely upon this study.
Q: An echocardiogram showed that I have a mild mitral valve leak. I have to take antibiotics before major surgery and dental work. Is this the same as mitral valve prolapse?
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A: No, they’re two different conditions. A leaky mitral valve is referred to as “mitral regurgitation.” What that means is that the valve that’s supposed to close and prevent blood from moving back into the left atrium (upper heart chamber) when the left ventricle contracts (to make your heartbeat) is leaky. A mild, non-symptomatic case of that is actually pretty common and nothing to worry about except for an increased risk of getting “endocarditis.”
Endocarditis is a bacterial infection of the lining of a heart valve that occurs because there’s an irregular surface on a leaky or narrowed heart valve for bacteria to latch on to and infect. When we have our teeth cleaned or we undergo certain surgical/dental procedures, bacteria is transiently introduced into the bloodstream.
Normally, this is no big deal unless there’s an irregular surface present — like a leaky heart valve. Antibiotics taken prior to such procedures prevents endocarditis from occurring. Mitral valve prolapse is a fairly common condition where the mitral valve is somewhat looser than normal, allowing one or more of the mitral valve leaflets to “prolapse” or bulge backward slightly into the left atrium when the left ventricle contracts. Prolapsing mitral valves don’t break down or need replacing. As long as there’s no associated heart murmur, it’s not necessary to take antibiotics prior to certain procedures because there’s no increased risk of endocarditis infection.
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Posted by john on June 10th, 2007 — in Paxil Top News
Plaintiffs who won a nationwide $63.8 million Paxil class action case have filed another claim in Madison County Circuit Court alleging two lawyers and a citizen from Florida conspired to exploit the U.S. legal system for their own personal gain.
Last month Madison County Associate Judge Ralph Mendelsohn approved the whopping settlement against GlaxoSmithKline (GSK) in a case that alleged the pharmaceutical company promoted Paxil and Paxil CR to children under 18, while withholding information about Paxil’s safety and effectiveness.
Teri Hoormann and Mary Kopsie were the class representatives in that case and again in the new one filed June 7.
In the newer case, Hoormann and Kopsie accuse defendants who objected to the settlement, lawyers N. Albert Bacharach, Jr. and Paul S. Rothstein, and citizen Lillian Rogers, of “extortionate behavior” that has caused damages to consumers across the country, while enriching the trio and their alleged co-conspirators with millions of dollars.
“As a result of these illegal activities, defendants are individually liable for three-times the amount that they have gained,” the complaint states.
Hoormann and Kopsie are represented by Stephen Swedlow of Chicago. Swedlow is one of the class attorneys in the Paxil case along with Stephen Tillery.
Tillery is not listed on the new class action, though he and Swedlow work closely in several class actions in Madison County.
Hoormann and Kopsie claim Bacharach and Rothstein assisted Rogers in preparing a “frivolous” objection to the Paxil class action settlement.
Under the settlement, anyone who purchased Paxil for someone under 18 will get 100 percent of their out-of-pocket expenses reimbursed if they have proof and file a claim by Aug. 31.
Anyone who does not have proof of purchase is still entitled to receive up to $100 if the claim is supported by an affidavit swearing that Paxil was purchased.
Hoormann and Kopsie allege the objection filed by the Florida trio was not filed in good faith and was intended to mask their wrongful threat to cause economic harm by impeding and delaying payment of the settlement unless they were paid money to which they have no lawful claim.
“Rogers’ sworn testimony reveals that her total damages in the Hoorman matter were ‘less than $40 but not more than $60′ for which the settlement provides full recovery,” the complaint states.
They claim that as a result of the defendants actions, they realized that their lawful benefits will be delayed thus causing them damage.
However, on the day of the fairness hearing on April 26, which was delayed about a month because of a scheduling conflict with Mendelsohn, objector attorneys actually negotiated a better settlement for the class.
Tillery also reportedly gave some of the objectors money out of the $16.8 million in attorneys fees he was to receive in an effort to execute the settlement.
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Under the preliminary agreement, undocumented claimants would have only received $15, but during negotiations, GSK raised the amount and removed the $300,000 cap on undocumented claims.
GSK had asked for the cap on undocumented claims so that it could cut losses on people who never purchased Paxil, but filed a claim anyway as a way to make a quick dollar.
Tillery also reached a settlement with attorneys in a competing class action that will compensate attorneys for the work they did.
Hoormann and Kopsie also claim this is not the first time this group of lawyers have “abused and misused” the legal process to extort money to which they have no lawful claim.
They claim the defendants are part of an enterprise that consists of themselves, other “objector” attorneys and other people who serve as objectors in violation of the Racketeer Influenced and Corrupt Organizations Act (RICO).
“The Enterprise is an ongoing organization, which engages in, and whose activities affect interstate commerce,” the complaint states.
Hoormann and Kopsie claim the three lawyers maintain an interest in and control of the enterprise through a pattern of racketeering activity.
According to Hoormann and Kopsie, the defendants’ control and participation in the enterprise is necessary for the successful operation of their scheme.
“In order to successfully obtain monies and other considerations from class settlements, defendants had to have a system which allows them to exact leverage over those classes,” the complaint states. “The Enterprise provides defendants that ability.”
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Posted by john on June 5th, 2007 — in Paxil Top News
A $64 million class action settlement recently approved by an Illinois judge means parents who bought their kids the antidepressant drug Paxil could be eligible to recoup their out-of-pocket expenses.
The Associated Press reports:
Parents who bought the antidepressant drug Paxil for their children may begin seeking reimbursements under a $64 million class-action deal to settle claims that the drug’s maker misled consumers about the medication’s safety. Under the deal, parents with proof that they bought GlaxoSmithKline PLC’s Paxil and Paxil CR, a controlled-release version of the drug, for their children can recoup out-of-pocket expenses. Parents who no longer have pharmacy records or receipts can get up to $100 refunded by signing a claim form that carries penalties for lying.
Britain-based GlaxoSmithKline denies claims it promoted the drug to children while withholding information about negative side effects, including increased suicidal behavior. Any money left over in the settlement fund is to be returned to GlaxoSmithKline. Anyone with a personal injury claim, including the parents of teenagers who took their own lives while taking Paxil, still can sue GlaxoSmithKline, as can insurers and governmental agencies who actually paid the bulk of the money.
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The settlement does not require GlaxoSmithKline to notify those who may be eligible for reimbursement.
Claim forms have to be filed by Aug. 31.
The FDA warned that an analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug. The FDA reported 11 suicide attempts — none resulting in death — among patients given Paxil in the trials. Just one of the patients who took a placebo attempted suicide. Given that small number, the FDA said then, the results ‘‘should be interpreted with caution.’’ All trial patients suffered from psychiatric disorders, including major depression. The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.
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Posted by john on June 2nd, 2007 — in Paxil Top News
PITTSBURGH, May 31 (UPI) — Mylan said Thursday the U.S. Food and Drug Administration tentatively approved its generic version of GlaxoSmithKline’s Paxil CR.
Mylan said its drug, known by its generic name of paroxetine extended-release tablets, is eligible for final approval on June 29, when Paxil CR’s pediatric exclusivity expires.
Paxil CR, a selective serotonin reuptake inhibitor indicated for treating depression, panic disorder, social anxiety disorder and premenstrual dysphoric disorder, generated $307 million in sales for the 12 months ending March 31.
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Side effects associated with Paxil CR include suicidal thoughts or actions, nausea, diarrhea, constipation, decreased appetite, abnormal vision and sleepiness.
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