Move over Zyprexa, Seroquel, trial on Risperdal
risperdal.jpg
Bloomberg News obtained company documents in a Louisiana trial seeking reimbursement of public funds paid to Johnson and Johnson for Risperdal. The drug was initially marketed to treat schizophrenia but its reach expanded. . . []
FDA cautions Zyprexa for teens
zyprexa.jpeg
Metabolic side effects will become standard black box warnings for adolescents taking olanzapine (Zyprexa) as a result of an FDA ruling. The new guidelines. . . []
Side effects largely untended
overweightscale(istock).jpg
Despite FDA warnings seven years ago, people taking second generation anti-psychotic (SGA) medicines are still not receiving adequate follow-up for life-shortening side effects. []
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, []
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... []
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... []
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... []
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... []
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... []
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... []
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... []
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... []
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... []
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... []
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.... []
"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... []
What's in an FDA approval
FDA approval, watchdogs and court cases: what this means for you []
Race, genetics, metabolism: drug therapy and clinical trials
by L. DiAnne Bradford

DBP3.jpgGenes 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. []
More on pharma influence
More on pharma: tracking prescribing habits of doctors, and the FDA. []
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... []
FDA changes review policy
[]
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... []
FDA's "no comment"
by Phyllis Vine

wellbutrinbuderprion.jpg

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.

[]
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... []
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.

[]

Older »

Phyllis Vine

Consider This

by Phyllis Vine

Relevant Sites

Featured Videos

Watch videos at Vodpod and politics videos and more of my videos

MIWatch Archives

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
verify here.



Search only trustworthy HONcode health websites:



Top 50 Wellness Guru Award
Accredited Online Colleges


Fatal error: Cannot redeclare is_valid_email() (previously declared in /home/miwatch/public_html/cgi-bin/mt/php/mt.php:825) in /home/miwatch/public_html/cgi-bin/mt/php/mt.php on line 831