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Mylan Gets Tentative Generic Paxil OK

May 31, 2007

PITTSBURGH — Drug maker Mylan Laboratories Inc. said Thursday that it received a tentative approval from the Food and Drug Administration for a generic version of GlaxoSmithKline PLC’s extended-release antidepressant Paxil.

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The tentative approval covers 12.5-milligram and 25-milligram extended-release tablets of paroxetine hydrochloride, the active ingredient in Paxil CR. The company said it is eligible for a final approval on June 29, when a patent extension for the drug expires.

GlaxoSmithKline reported $73 million in U.S. sales of Paxil CR in 2006.

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U.S. Judge Approves $64 Million Settlement Over Drug Paxil

May 29, 2007

ST. LOUIS_Parents who bought the antidepressant drug Paxil for their children may begin seeking reimbursements under a $64 million (?48 million) class-action deal to settle claims that the drug’s maker misled consumers about the medication’s safety.

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Under the deal, announced in April and granted final approval last week by a judge in Madison County, Illinois, 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 (?74) refunded by signing a …

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Drug Wars At The Big-Box Stores

May 24, 2007

In 2004, when the patent for the popular allergy drug Claritin expired, 20 pills of the generic version sold anywhere from $10 to $30, depending on the region of the country. Today, the same amount is $4 at the 4,000 Sams’ Club and Wal-Mart Stores (WMT) and 1,500 Target (TGT) stores.

Price programs like that have boosted sales at both discount retailers in the latest quarter. Through them, customers can fill a 30-day prescription on drugs such as Paroxetine, the generic version of the antidepressant Paxil, and cholesterol-lowering Mevocor’s generic, Lovastatin, for just $4.

The Right Prescription for Growth

In the first quarter, Minnesota-based Target saw profits jump 18%, to $651 million in the first quarter that ended Apr. 29, while sales increased 9.2%, to $14 billion. The retailer’s pharmacy sales were hopping, and the increased number of folks at the pharmacy helped boost sales of other products, too.

“We are getting substantially more new guests and new prescriptions,” Target President Gregg Steinhafel said May 23 on a conference call with analysts to discuss earnings. Earlier this month, Wal-Mart reported a similar sales bump. “Our pharmacy area continues to see benefits from the $4 generic prescription program,” said Eduardo Castro-Wright, chief executive of Wal-Mart’s U.S. operations, citing prescription sales growth that “continue to run in the mid-teens.”

For Wal-Mart, the generic drugs initiative presents fertile ground for growth. Most people need monthly prescription refills, making drug sales a great way to lure customers to stores more often. “You’re looking at a loss leader–the idea is they come in to buy one product and will buy three more,” says Robert Passikoff, president of New York brand consultant Brand Keys.

However, Wal-Mart executives have insisted they won’t sell the drugs at a loss. That’s in part because the company recognizes that the generic drugs are a low-price commodity. As a result, it can employ its highly efficient logistics and technology–and the famous Wal-Mart pressure on suppliers–to squeeze out even the smallest margins that make a difference to profits at the high volumes Wal-Mart can sell.

Over at Target, though, the additional customers have come at an important cost. “Obviously [$4 generics] is putting strain on the margin rate within our Rx and pharmacy business group,” says Target’s Steinhafel. But he notes that the increased numbers of customers have helped sales of over-the-counter drugs and other products throughout the store.

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For now, Target isn’t cutting any of its pharmacy staff, despite lower margins. However, Passikoff says that lover the long term, many of these retailers might find it difficult to continue to offer such low-priced generics. “It’s a game of marketing poker, and the one who can wait the longest and has financial wherewithal to invest in that strategy will win,” says Passikoff.

A Scramble by Retailers

The effect has been widespread. Wal-Mart’s mid-September announcement that it was launching a test program to sell 291 generic drugs for $4 a prescription in the Tampa area set off a scramble among all pharmacy retailers. Target matched Wal-Mart’s offer immediately, and K-Mart (SHLD) publicized its 90-day generics for $15. Other regional supermarket stores like Giant Eagle of Pennsylvania and Meijer of Michigan even started offering a handful of generic antibiotics for free.

Consumers’ response to Wal-Mart’s Tampa test was so dramatic that the company decided to expand the $4 generic drugs to dozens of states just two weeks later. It’s easy to understand why. The benefit for consumers was striking–the National Association of Chain Drug Stores says that the cost of a 30-day supply of an average generic prescription drug was about $29.82 in 2005, compared with $101.71 for name-brand prescriptions.

Wal-Mart’s price was even lower than the $10 co-pay required by most employer health plans. “The prescriptions on our $4 program now make up more than 37% of all prescriptions we fill,” says Bill Simon, chief operating officer of the U.S. Wal-Mart Stores Division. “The response nationwide has more than exceeded our expectations.” Wal-Mart says the program has saved consumers more than $340 million.

The End of Unfair Mark-Ups?

The simple $4 price has certainly brought transparency to the retail drug arena. Until recently, when a drug’s patent expired, pharmacies would charge as much as they liked for the generic version. While it would be far cheaper than the brand-name version, many pharmacies would mark up prices dramatically.

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One study found that the mark-ups would be as high as 4,000%. For instance, in 2004, soon after the patent for the antidepressant Prozac expired, health economist Devon Herrick found that a 30-day prescription of its generic version, Fluoxetine, was selling in central Iowa for $55, in some places in Florida for $43, in Virginia for $45, and at the discount wholesale club Costco Wholesale (COST) for $7.09.

“People are just not aware of these variations, and most of them don’t compare prices,” says Herrick, a senior fellow at the National Center for Policy Analysis, a nonprofit research group. “Pharmacies take advantage of consumers’ lack of knowledge and mark up prices substantially.”

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Groups Warn against taking Paxil while Pregnant

May 21, 2007

Paxil, a drug marketed as a way to treat depression, may have caused a lot of suffering for families after fetuses exposed to the drug were born with birth defects. Women took Paxil while pregnant, believing professionals who told them that Paxil was perfectly safe.

The truth is that Paxil can cause serious birth defects in infants. Defects that have been reported include minor valve problems, heart murmurs, and holes in the heart. In some cases, infants have had defects so severe they required heart transplants.

Paxil baby birth defectsPaxil is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It is usually prescribed to treat depression, anxiety, and other related disorders. However, there are three groups of people who should not take Paxil. Those groups are senior citizens, youth under the age of eighteen, and women who are pregnant or nursing. Recently, information has come to light indicating that GlaxoSmithKine, makers of Paxil, knew about the risks associated with taking their antidepressant.

Studies released over the past few years have shown links between the use of Paxil by pregnant women and a risk of birth defects. The studies led to the FDA releasing a public health advisory in 2005 that the use of Paxil (known generically as paroxetine) during the first trimester of pregnancy could increase the risk of congenital malformations. According to the FDA, “…these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.”

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In 2006 the New England Journal of Medicine published the reports of a study that concluded that the use of Paxil after the 20th week of a pregnancy was associated with a risk of the development of PPHN (primary pulmonary hypertension of the newborn) in infants. Other difficulties for newborns exposed to Paxil prior to birth include seizures, altered body temperature, irritability, withdrawal symptoms, and feeding problems.

The FDA has upgraded the Paxil warning from category “C” to category “D.” Category “D” drugs have been shown to have a risk to fetuses.

Women who are pregnant or thinking about becoming pregnant should speak with their doctor about the possibility of taking non-SSRI antidepressants. The American College of Obstetricians and Gynecologists is advising that “…a particular SSRI medication known as paroxetine (Paxil) be avoided, when possible, by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative defects.”

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FDA wants more warnings on Paxil labels

May 21, 2007

A report from AssociatedContent.com says that the Food and Drug Adminstration (FDA) has recently proposed the idea of drug makers putting more label warnings of Paxil and other antidepressant drugs for those under age 25.

The reason for this stems from studies that show an increase in suicidal thoughts when people under age 25 take antidepressant drugs such as Paxil. Apparently GlaxoSmithKline, manufacturer of Paxil, and the FDA said in May 2006 that Paxil caused an increase in suicidal thoughts among its younger users.

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The FDA reviewed 372 studies with 100,000 patients and 11 antidepressants. They concluded that young adults needed to be closely monitored if place on the drugs, particularly during the first two months of the drug being introduced to the system. That was based on the fact that there were elevated suicidal thoughts and actions in those ages 24 and younger.

90 million prescriptions for antidepressants are written each year. Many have charged that America is overmedicated and that doctors are just dispensing out antidepressants for anyone that asks without regard to their necessity.

Paxil has also been known to cause birth defects and other adverse side effects in those who use it. If you or someone you know has experienced adverse side effects while using Paxil or another drug, it may be in your best interest to consult an attorney. Click on the form to the right for a free case evaluation.

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Doctors hand out a record 31m antidepressant prescriptions

May 16, 2007

PRESCRIPTIONS for antidepressant drugs are at a record high, despite warnings that many people would benefit more from alternative treatments.

The use of drugs such as Seroxat and Prozac increased by 10 per cent last year as doctors wrote more than 31 million prescriptions for antidepressants.

There are now believed to be several million people taking pills for depression which have been given on repeat prescriptions over long periods.

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The cost to the NHS last year was GBP291.5million.

The figures, in a report from the leading mental health charity Mind, come despite growing concerns about the country’s reliance …

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Antidepressant use rises to record level

May 15, 2007

Antidepressant use has reached record levels in England with doctors writing 6% more prescriptions than in the previous year.

Around 31 million prescriptions for antidepressant drugs were handed out despite guidance indicating alternative therapies.

One charity group, Mind, has advocated a new “green agenda” for mental health suggesting that a walk in the countryside could help dispel depressive feelings.

According to recent research: 71% reported depression decreased after a green walk, whereas 22% reported that depression increased after an urban walk.

Mind called for “ecotherapy” to be recognised as a clinically-valid frontline treatment for mental health problems.

Ecotherapy involves getting outdoors and getting active in a green environment as a way of boosting mental wellbeing. Whether it’s taking regular walks in the park, flying a kite or participating in a gardening therapy project, green exercise is proven to have huge benefits for mental health.

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Mind Chief Executive Paul Farmer said: “Mind sees ecotherapy as an important part of the future for mental health. It’s a credible, clinically-valid treatment option and needs to be prescribed by GPs, especially when for many people access to treatments other than antidepressants is extremely limited. We’re not saying that ecotherapy can replace drugs but that the debate needs to be broadened.

“Hundreds of people have benefited from the green projects run by our local Mind associations but if prescribing ecotherapy was part of mainstream practice it could potentially help the millions of people across the country who are affected by mental distress.”

The prescription of care farms as a treatment for mental distress has been highly successful on the continent but the UK is lagging far behind Europe – there are only 43 care farms in the UK, none of which are directed at mental health, compared to 600 in the Netherlands and 400 in Norway.

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Antidepressants grow new nerve cells

May 10, 2007

New research finds that antidepressant treatment induces new nerve cell growth in the hippocampus, a brain area responsible for learning and memory, in adult monkeys. Scientists believe a similar process may occur in humans. If so, the finding could help explain the he effectiveness of antidepressant treatments.

In adult monkeys, an antidepressant treatment has induced new nerve cell growth in the hippocampus, a brain area responsible for learning and memory.

The results, the first from nonhuman primates, are similar to those previously seen in rodents. They suggest that creation of new nerve cells, a process known as neurogenesis, is an important part of antidepressant therapy.

Researcher Tarique Perera, MD, at Columbia University, and colleagues observed changes in the number of brain cells in the dentate gyrus region of the hippocampus. The study is published in The Journal of Neuroscience.

The growth of new nerve cells in the hippocampus has been suggested as the way antidepressants work in rodents, says Eric Nestler, MD, PhD, of the University of Texas Southwestern Medical Center.

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“However, the clinical relevance of this action has remained controversial, in part, because of uncertainty as to whether similar neurogenesis occurs in humans,” he says.

“This finding further supports the potential clinical relevance of changes in neurogenesis seen in rodent models.”

Perera and the team treated a group of monkeys with electroconvulsive shock (ECS), an animal version of the highly effective clinical antidepressant electroconvulsive therapy. They saw an increase in new nerve cells in the hippocampus. Over four weeks, a majority of these cells became mature neurons.

These brain changes were not a response to tissue damage, Perera says, because no evidence of increased cell death was found in the ECS treated animals. In fact, the researchers found that the ECS treatments increased production of a protein (BCL2) that protects neurons from damage.

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Change Suicide Warning On Antidepressants FDA Asks Drug Makers

May 8, 2007

The US Food and Drug Administration (FDA) has asked makers of all antidepressant drugs to change the existing “black box” labels on their products to warn about increased risk of suicidality (suicidal thinking and behaviour) among young adults aged 18 to 24 in the first few weeks of treatment.

The FDA has also asked the drug companies to revise the existing warning to show there is no evidence this risk exists for adults over 24, and indeed for those aged 65 and older the scientific data suggests the suicidality risk is decreased.

The update request is welcomed by psychiatrists and other health professionals.

The American Psychiatric Association (APA) said:

“The FDA’s new labeling acknowledges, for the first time, that untreated depression puts people at risk for suicide.”

They said studies showed that the old label issued in 2004 was associated with a steep drop in use of antidepressants and was followed by an increase in the rate of suicide “reversing a decade-long decline in suicide deaths in the United States”.

The FDA said the emphasis on the new labels should be that depression and other serious psychiatric illnesses are themselves the most important causes of suicide.

Director of FDA’s Center for Drug Evaluation and Research, Dr Steven Galson said yesterday that:

“Today’s actions represent FDA’s commitment to a high level of post-marketing evaluation of drug products.”

“Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks,” he explained.

The FDA recommends that people who are currently taking antidepressants should not stop taking them as a result of hearing this news. If you are worried about it, talk to your doctor, is their advice.

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The warning revision applies to all antidepressants and comes in the wake of controlled trials that showed a reasonably consistent risk of suicidality across most of the antidepressant drug categories. The FDA said that the evidence does not support excluding any antidepressant medication from this update request.

This update request follows the labelling changes made in 2005 to warn of increased suicidality in children and adolescents taking antidepressants.

Since then, the FDA undertook a comprehensive review of 295 drug trials examining the risk of suicidality among adults taking antidepressants.

The trials included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric conditions.

The results was that in December last year, the FDA’s Psychopharmacologic Drugs Advisory Committee said labels should be changed to tell doctors about the increased risk of suicidality among younger adults taking antidepressants.

The Committee also said the labels should remind doctors that the disorders themselves present the greater risk, and that among older adults the antidepressants do not carry the suicidality risk and have an apparent beneficial effect.

The FDA is preparing drafts of patient guides and wording for the labels. The manufacturers have 30 days to submit their own versions for FDA review.

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