News: Move over Zyprexa, Seroquel, trial on Risperdal

News: FDA cautions Zyprexa for teens

News: Side effects largely untended

News: FDA seeks public comment on ECT
The FDA is asking for comment to determine whether it should reclassify ECT to require "reasonable assurance of the safety and effectiveness" of the mechanical devices used for electroconvulsive therapy. ECT was already in use when the FDA codified mechanical devices,
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News: FDA green lights pediatric antipsychotic meds
An FDA review panel approved drugs, saying they met safety standards for treating bipolar and schizophrenia in children. AstraZeneca's Seroquel and Pfizer Inc.'s Geodone were approved; Eli Lilly's Zyprexa was given back-up status should the others fail. All have been the subject of controversial court cases involving allegations of withholding information and dangerous side effects. An FDA report indicates children already account for something between 5 percent and 11 percent of these drugs, bringing the total to five for the...
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News: Additions to Obama's health team
Three people are likely to complete the top tier of President Obama's health team. Rumors have been circulating for several weeks, and with it all but confirmed officially the media is reporting Dr. Margaret Hamburg will receive the nod for commissioner of the Food and Drug Administration (FDA), an agency that has been plagued with problems. Dr. Joshua Sharfstein is likely to be named as deputy commissioner. Both have experience as health commissioners in large cities (Hamburg formerly in New...
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News: Another try to regulate tobacco
A bill (HR 1256) to allow the FDA to regulate smoking is long overdue said Rep. Henry Waxman (D-Cal.). The powerful committee chairman signed up 124 co-sponsors for a smoking prevention bill which he introduced on March 3. (It is similar to a bill (HR 1108) the House passed last year.) Despite support for regulating nicotine, some doubt the FDA is capable of regulating this industry, and critics fear the intent is to eliminate rather than control nicotine. Smoking is...
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News: FDA on list of high risk agencies
A GAO report put the Food and Drug Administration (FDA) on the list of "high risk" areas vulnerable to fraud, waste, mismanagement. Prepared for the 111th Congress, the report notes there are "significant challenges that compromise its ability to protect Americans from unsafe and ineffective products." The GAO calls for the agency to: "improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and traced promotional materials for review, and...
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News: Waxman questions pharma influence on FDA
Rep. Henry Waxman Rep. Henry Waxman (D-Cal), chair of the House oversight committee, asked FDA Commissioner Andrew von Eschenbach to explain how priorities were established which seemed to have tipped from protecting consumers to protecting drug companies. He cites employees for whom the agency has become a revolving door to pharma, asserts the agency protects drug makers instead of the consumers, and asks for clarification about distribution of journal articles and preemptions for medical devices. Waxman's concerns about preemptions...
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News: Waxman questions pharma influence on FDA
Rep. Henry Waxman Rep. Henry Waxman (D-Cal), chair of the House oversight committee, asked FDA Commissioner Andrew von Eschenbach to explain how priorities were established which seemed to have tipped from protecting consumers to protecting drug companies. He cites employees for whom the agency has become a revolving door to pharma, asserts the agency protects drug makers instead of the consumers, and asks for clarification about distribution of journal articles and preemptions for medical devices. Waxman's concerns about preemptions...
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News: FDA lashes Ranbaxy about generic drugs
The Federal Drug Administration (FDA) sent warnings to Ranbaxy, a generic drug company based in India, partially restricting imports of some drugs while it was highly critical of the company's sloppy quality control for others. Redactions in the letters make it impossible to know whether the problems cited apply to the anti-anxiety and anti-depressants Ranbaxy makes. While the FDA was coming down on Ranbaxy, Rep. John Dingell, chair of the House Committee on Energy and Commerce, released a statement asking...
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News: Seroquel update from FDA
Seroquel appears on the FDA's list of drugs with serious risks that were compiled by the Adverse Event Report System between Jan-March 2008. The FDA warning attributed labeling confusion on sample packs to overdoses. Seroquel is made by AstraZeneca and is a mood stabilizer prescribed for bi-polar disorder and schizophrenia....
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Book Reviews: "Comfortably Numb: How Psychiatry is Medicating a Nation," Charles Barber
by Alison Bateman-House* Charles Barber's latest book, Comfortably Numb: How Psychiatry is Medicating a Nation (Pantheon Books), is a passionate, multi-pronged critique of the state of psychiatry in the United States. Barber takes as his starting point his fourteen years working with the mentally ill homeless in New York City. In positions ranging from a counselor to a senior social services administrator, he worked on the streets, in shelters, and in supportive residential programs with clients who were dealing with...
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Consider This: What's in an FDA approval
FDA approval, watchdogs and court cases: what this means for you
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Commentary: Race, genetics, metabolism: drug therapy and clinical trials
by L. DiAnne Bradford

Genes influence how drugs are metabolized. Yet most clinical drug trials are conducted on Caucasians, with little study of Asians and African Americans. Noted psychopharmacologist, Dr. DiAnne Bradford, writes about the impact of these genetic differences for drug therapies.
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Consider This: More on pharma influence
More on pharma: tracking prescribing habits of doctors, and the FDA.
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News: FDA's effectiveness questioned
A House subcommittee voted to subpoena former FDA officials to answer questions about fraudulent clinical data used to approve Ketek, an antibiotic with life-threatening complications including liver failure. The subpoena came at the end of a day when witness after witness testified that the FDA has fallen short of its oversight responsibilities to regulate and monitor food, drugs and medical devices. An outdated system of information technology, and budgetary constraints were among the factors enumerated by witnesses before the Subcommittee...
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News: FDA changes review policy
The New York Times reports an unannounced shift in FDA policy acknowledging that many drugs carry risks for psychiatric side effects. A questionnaire designed to measure suicidal thoughts, and developed by Columbia University's researcher Kelly L. Posner, led to the agency's reassessment....
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News: Publication bias for antidepressants
The selection of articles reaching print might overstate the benefit of antidepressants, according to a study published in the New England Journal of Medicine. The authors examined clinical studies of 12 antidepressants, involving 12,564 patients, registered with the FDA and concluded that most published studies showed positive results. But one-third of the clinical studies showing that the agent was no better than a placebo were not published. Selective reporting of clinical trials which emphasize only the benefits, “may have adverse...
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Consider This: FDA's "no comment"
by Phyllis Vine



Despite complaints over several months about side effects when substituting Budeprion XL 300, a generic antidepressant for the branded Wellbutrin 300 XL, the FDA has taken no steps to alert consumers or physicians.


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News: Chantix warnings from FDA
People taking Chantix, a drug to stop smoking, have reported suicidal thoughts, and mood changes including erratic and aggressive behavior, leading the FDA to issue a warning to patients and health care providers. Pfizer is working with the FDA to supply additional pertinent information. Nearly two-thirds of all people with a mental illness smoke -- far greater than the rest of the population -- and targeted campaigns have addressed this health hazard in hospital and community settings. Complaints also came...
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Commentary: Depression, advertising and pharma
by Julie Donahue
If pharmaceuticals educate consumers, instead of targeting them for specific drugs, can they still meet the bottom line? These are among the questions Professor Julie Donahue raises about depression and advertising for antidepressants.


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Consider This: Generic antidepressant not equal to patented product
A generic antidepressant has different action and side effects.


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News: Inspector General scores FDA
A report issued (9.28) by the Office of Inspector General concludes that the Food and Drug Administration (FDA) provides insufficient oversight for monitoring clinical trials of medicine and medical devices coming to market. The report states, "FDA’s guidance and regulations for clinical trials have fallen behind industry practices." Those practices now include multi-site trials (averaging 23 sites per trial), with roughly 20 to 25 percent of them outside the United States. In addition, the FDA was able to inspect less...
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News: Haldol relabeled
The FDA issued an alert that the intravenous administration of haloperidol, which is often used off-label to control agitation, can lead to sudden cardiac death. Johnson and Johnson supplied information to the agency from a post-marketing analysis requested by Italy's Drug Agency. The pharmaceutical company has updated its label with detailed warnings....
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News: FDA approves pediatric antipsychotic
Following double-blind controlled trials, the FDA approved Risperidal for pediatric use in two conditions, schizophrenia (ages 13-17), and bipolar disorders (ages 10-17). It was approved in 1992 to treat adults with schizophrenia....
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News: FDA will review Abilify for depression
Bristol-Meyers Squibb Co. announced that the FDA agreed to a priority review of Abilify for treating depression. The drug was approved for treating schiziophrenia in 2002, for bipolar in 2004, and an oral solution hit the market in 2005. Priority review shrinks the process to six months....
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News: FDA stops obesity drug
Citing safety factors, the FDA rejected a drug called Zimulti used to fight hunger. Side effects included risk factors for depression, phobias, PTSD and suicidal thoughts....
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News: A comment on the FDA’s decision for black-box warning
New England Journal of Medicine, May 7, 2007 (on-line version) An op-ed appearing in the New England Journal of Medicine analyzes the data used by the FDA -- plus some it didn’t include -- to arrive at the recent decision to expandblack box warnings about antidepressants and the risk of suicide for people under the age of 24. “The new black-box warning is clearly an attempt to balance the small risk posed by antidepressants against their well-documented benefits. But this...
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Links: Government Resources
Information about public resources, medication, legislation, or policy.
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Links: Find Help
New visitors will find useful resources for narrowing a search or for general information. Updated 11.02.07.
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