ANTI DEPRESSANT DRUG BLOG

Biovail sues FDA over generic Wellbutrin

August 24, 2006

Biovail Corp. (BVF.TO: Quote, Profile, Research) said on Thursday it is suing the U.S. Food and Drug Administration over what constitutes a generic copy of its flagship antidepressant drug Wellbutrin XL.

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Biovail said it is seeking a temporary restraining order and a preliminary injunction directing the FDA to resolve the issues the company raised in a so-called Citizen’s Petition at least one week prior to the FDA’s approval of any generic versions of Wellbutrin XL.

Biovail said its petition is intended to protect the public against the potentially harmful effects of generic versions of the drug that may not be bioequivalent to Biovail’s branded product.

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Study Supports Antidepressant Link to Suicides Among Children

August 20, 2006

Results of a new study reinforce previous analyses that show increased suicide attempts and completed suicides among children and adolescents treated for depression. Adults do not appear to share this increased risk.

“It is important to move beyond ecologic studies to examine longitudinal population-based data that include temporal relationships between antidepressant drug use and suicide attempts and death for individual patients,” Dr. Mark Olfson and his co-investigators write in their paper in the Archives of General Psychiatry for August.

To that end, Dr. Olfson, from the College of Physicians and Surgeons of Columbia University in New York, and his team designed a case-control study, using data provided by the center for Medicare and Medicaid Services, to evaluate the risk of suicide among patients following discharge after hospitalization for treatment of depression.

This latter criterion “sought to ensure that cases (suicide attempt and suicide death) and controls (no suicide attempt and no suicide death) who did and did not receive antidepressant treatment had a high and comparable level of illness severity.”

Each case of attempted or completed suicide was matched to as many as five controls by age, sex, race or ethnicity, state of residence, date of hospital discharge, substance use disorder, recent suicide attempt, and recent treatment with psychotropic drugs other than antidepressants.

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Included were 263 children and adolescents who attempted suicide, and 8 who completed suicide. Corresponding numbers among adults were 621 and 86.

The results showed that children and adolescents treated with an antidepressant drug were significantly more likely to attempt suicide than those who were not (OR 1.52). However, the relationship was significant only among white children and adolescents, but not among minority patients.

The results also showed that children and adolescents who completed suicide were significantly more likely to have been treated with antidepressants (OR, 15.62). However, Dr. Olfson’s group urges caution in interpreting this finding, since it is based on only 8 suicide deaths.

No such association was observed among adults.

“These findings support careful clinical monitoring during antidepressant drug treatment of severely depressed young people,” the team concludes.

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Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults

August 15, 2006

Mark Olfson, MD, MPH; Steven C. Marcus, PhD; David Shaffer, MD

Arch Gen Psychiatry. 2006;63:865-872.

Context The Food and Drug Administration has issued a boxed warning concerning increased suicidal ideation and behavior associated with antidepressant drug treatment in children and adolescents. It is unknown whether antidepressant agents increase the risk of suicide death in children or adults.

Objective To estimate the relative risk of suicide attempt and suicide death in severely depressed children and adults treated with antidepressant drugs vs those not treated with antidepressant drugs.

Design Matched case-control study.

Setting Outpatient treatment settings in the United States.

Participants Medicaid beneficiaries from all 50 states who received inpatient treatment for depression, excluding patients treated for pregnancy, bipolar disorder, schizophrenia or other psychoses, mental retardation, dementia, or delirium. Controls were matched to cases for age, sex, race or ethnicity, state of residence, substance use disorder, recent suicide attempt, number of days since hospital discharge, and recent treatment with antipsychotic, anxiolytic/hypnotic, mood stabilizer, and stimulant medications.

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Main Outcome Measures Suicide attempts and suicide deaths.

Results In adults (aged 19-64 years), antidepressant drug treatment was not significantly associated with suicide attempts (odds ratio [OR], 1.10; 95% confidence interval [CI], 0.86-1.39 [521 cases and 2394 controls]) or suicide deaths (OR, 0.90; 95% CI, 0.52-1.55 [86 cases and 396 controls]). However, in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts (OR, 1.52; 95% CI, 1.12-2.07 [263 cases and 1241 controls]) and suicide deaths (OR, 15.62; 95% CI, 1.65-infinity [8 cases and 39 controls]).

Conclusions In these high-risk patients, antidepressant drug treatment does not seem to be related to suicide attempts and death in adults but might be related in children and adolescents. These findings support careful clinical monitoring during antidepressant drug treatment of severely depressed young people.

Author Affiliations: New York State Psychiatric Institute/Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York (Drs Olfson and Shaffer); and University of Pennsylvania School of Social Policy and Practice, Philadelphia (Dr Marcus).

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Morristown doctor seeking guides for antidepressants

August 14, 2006

While a national study recently found that antidepressant patients are not following up with health-care professionals as often as the U.S. Food and Drug Administration recommends, Dr. Thomas Zaubler believes that the issue here is “the divergence of opinion about the frequency of visits.”

“I think what we need to do is come to a consensus about a follow-up guideline,” said Zaubler, chairman of the psychiatry department at Morristown Memorial Hospital.

Two-thirds of children and even more adults did not see a doctor or therapist for mental health care once within a month of beginning drug treatment, according to the study by Medco Health Solutions Inc., which manages prescription benefits for health plans.

Medco’s study of 79,488 adults and 5,026 youngsters reviewed prescription and doctor visit records from July 2001 through September 2003. That was before the government urged drug makers to put warnings on their products calling for close monitoring of suicidal thoughts or violent behavior in the early weeks after starting the drugs.

“Many of these people probably should have had more follow-up than they did, regardless of the FDA guidelines,”said Dr. Glen Stettin of Franklin Lakes-based Medco, which paid for the study.

In early 2004, the FDA recommended that new antidepressant users see a doctor once a week for the first month and three more times in the following two months.

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That advice is the agency’s “best estimate” of what’s reasonable, said Dr. Thomas Laughren, director of the Division of Psychiatry Products at the FDA.

Zaubler said many experts disagree with the FDA standard, which was the guideline used in the study.

The study compared the frequency of visits the patients have once treatment with antidepressants is initiated and the FDA’s follow-up standards.

During the first four weeks, the study reported, only about 25 percent of patients saw health-care providers. In the first four weeks, 55 percent of patients followed up with their doctors.

“In practice,” Zaubler said, “visits are less frequent than (the FDA standards).”

Due to the demand on time and staff, Zaubler said, “most physicians don’t routinely schedule follow-ups for the first two weeks.”

He added, “It’s very hard for health-care providers to see someone on a weekly basis.”

According to Zaubler, there are two reasons why follow-ups are recommended. The first is to monitor for the possibility of suicide.

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Antidepros plus therapy needed

August 10, 2006

Most patients who are prescribed antidepressant drugs don’t get the psychotherapy they require immediately after they start taking the drugs, a period of time when there can be a temporary increased risk for suicidal behaviour, a US studResearchers reviewed prescription and doctor visit records of nearly 80 000 adults and about 5 000 youngsters from July 2001 through September 2003 and found that only about a third of children and even fewer adults saw a doctor or therapist for mental health care within a month of beginning antidepressant drug treatment, the Associated Press reported.

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Factors that may contribute to the problem include: cost of therapy, a shortage of psychiatrists in some areas, and a lack of follow-up by busy family physicians.

The study - by Medco Health Solutions Inc., which manages prescription benefits for health plans - was conducted before the US Food and Drug Administration’s 2004 recommendation that new antidepressant users see a doctor once a week during the first month of antidepressant treatment and three more times in the following two months, the AP reported.

The FDA has also asked drug companies to place warnings on antidepressant drugs that call for close monitoring of suicidal thoughts or violent behaviour in the first few weeks after patients start treatment. – (HealthDayNews)y finds.

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Teva Pharma Gets Final Approval For Antidepressant Drug - Update

August 7, 2006

Teva Pharmaceutical Industries Ltd. A pharmaceutical company, revealed final approval by the U.S. Food and Drug Administration for its Venlafaxine Hydrochloride Tablets in strengths of 25 mg, 37.5 mg, 50 mg, 75 mg, and 100 mg.

The Petach Tikva, Israel based Teva said its Abbreviated New Drug Application or ANDA was approved by the FDA and shipments of the drug is expected to begin almost immediately. Teva has over 80% of its sales centered in North America and Europe.

Venlafaxine Hydrochloride Tablets, indicated in the treatment of major depressive disorders, is an AB-rated generic equivalent of Wyeth’s Effexor Tablets, with annual sales of over $152 million.

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TEVA is gaining $0.55 or 1.61% and currently trades at $34.76, on a volume of 1.57 million shares on the Nasdaq.

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UPDATE 2-Glaxo down as copycat antidepressant wins ruling

August 2, 2006

Shares in GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) fell over 2 percent on Wednesday after a U.S. court ruling that could open the way for a cheap, copycat version of its antidepressant pill Wellbutrin XL.

A U.S. judge ruled on Tuesday that a drug made by Anchen Pharmaceuticals Inc. did not infringe a patent held by Canada’s Biovail Corp (BVF.TO: Quote, Profile, Research), GlaxoSmithKline’s (GSK) partner for Wellbutrin XL, according to a report on Bloomberg.

GSK, Europe’s biggest drugmaker, said the ruling would not affect its earnings forecast for 2006.

But Morgan Stanley analysts said the news could bring down analysts’ consensus forecast in 2007.

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“This unexpected negative news on Wellbutrin XL is likely to increase awareness of potential downside risk to other mature drugs,” they wrote in a research note, highlighting threats to Requip for restless leg syndrome and migraine drug Imitrex.

At 1140 GMT, GSK shares were down 2.4 percent at 14.26 pounds, the second-biggest fall on the UK’s benchmark FTSE-100 < .FTSE> and valuing the firm at about 83 billion pounds ($158 billion).

However, Merrill Lynch analysts expect Biovail to appeal against the decision and said a ruling could be up to a year away.

They are assuming a mid-2007 launch for generic Wellbutrin XL and said a January launch would cut just 2 percent off their earnings forecast.

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