October 26

Prescriptions for antidepressant declined 10%

Prescriptions for antidepressant declined 10%

Thu, 13 May 2004

The controversy over the safety of antidepressant drugs is broadening. The Newark Star Ledger reports a drop in antidepressant prescriptions since the Feb 2 FDA advisory committee meeting. Disclosure of long concealed evidence about the severe adverse drug effects–as well as the absence of scientific evidence of their effectiveness for children–is leading parents to say NO to doctors who promote these drugs.

Additionally, several–but not all–SSRI and SNRI antidepressant drug manufacturers have issued new warning labels (April 2004)–although these warnings are still not prominently displayed in a Black Box.

According to the new warning labels for: Celexa (citalopram) / Lexapro / Effexor (Venlafaxine) / Paxil (paroxetine) / Zyban / Wellbutrin, SSRIs and SNRIs are linked to “Clinical Worsening and Suicidal Risk” in both children and adults.

Among the psychiatric adverse drug effects listed: “anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants…”

“Families and caregivers of patients being treated with antidepressants for major depressive disorder OR OTHER INDICATIONS, BOTH PSYCHIATRIC AND NONPSYCHIATRIC, should be alerted about the need to monitor patients for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.” [emphasis added]

** The acknowledgement that adverse effects–including “emergence of suicidality” (suicidal thinking and behavior)–occur in depressed and nondepressed people, even in patients with no psychiatric condition–overturns claims made by the psychiatric / drug establishment, that the underlying depression was to blame, not the drugs.

The acknowledgement, based on company held evidence, validates the Feb 2, 2004 testimonies of families whose children became suicidal when an antidepressant was prescribed for migrane headache, lyme diseases or social phobia. The acknowledgement puts physicians and caregivers on notice that the drugs produce these behavioral symptoms.

No one knows how these drugs actually “work” or how permanent the damaging effects in the brain and central nervous system may be. Prescribing doctors can’t predict who will be at risk of drug-induced life-threatening behavior. People who take the drugs without proper monitoring, or buy antidepressants on the internet are playing Russian Roulette with their lives and their family members’ lives.

Why, one wonders, were no new warning labels issued by Eli Lilly (manufacturers of Prozac (fluoxetine) or strattera (atomoxetine)? Why has Pfizer (manufacturer of Zoloft (sertraline) failed to issue warnings?

The antidepressant drug controversy has revealed that the public cannot trust healthcare professionals who have undisclosed financial ties to drug manufacturers. Doctors who served as paid industry consultants failed to inform patients and the scientific community about the hazards posed by antidepressants.

The controversy also laid bare the complicity of government agencies–most notably the FDA and NIH–who helped industry conceal clinical trial evidence. Officials of these were also complicit in misrepresenting the evidence and continuing to mislead the public with false reassurances about the drugs’ safety, while downplaying the scientifically validated hazards of these drugs. See: NIH April 23 statement: http://www.nimh.nih.gov/press/StmntAntidepmeds.cfm See: AHRP Open Letter to NIMH: http://www.ahrp.org/infomail/04/04/30.html See: FDA Suppression of its own expert report: https://ahrp.org/infomail/04/04/16.php

The public can no longer trust the validity of drug-related information from presumed authoritative sources–including prestigious US medical journals whose dependency on pharmaceutical advertising dollars has led to the dissemination of invalid, inaccurate reports that concealed evidence–lest the evidence would harm industry’s marketing goals. See Seroxat/Paxil Adolescent Depression: Position Piece on the Phase II Clinical Trials: https://ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

The Alliance for Human Research Protection has assumed the task of disseminating credible information that drug companies and their collaborators in the medical / psychiatric establishment prefer to keep hidden.

When FDA officials blocked presentations by experts–even their own–whose analyses of the data revealed a suicidal link to SSRIs, AHRP convened a press briefing with six independent scientists–so that the public would learn the facts. See: https://ahrp.org/risks/SSRIsuicide0204.php

AHRP believes that the best defense against becoming one of hundreds of thousands of victims who each year suffer severe–some fatal–medication-related injuries, is to become an informed consumer.

AHRP tracks information about medical ethics, conflict of interest, research integrity, patient rights, and policies affecting children’s health. Our Infomails reach key policymakers, opinion shapers, and journalists–as well as concerned citizens. We’re told our informed advocacy is having an impact.

If you think the service we provide is important, help us continue the flow of information about public health policy issues.

AHRP does not accept funds from pharmaceutical companies.

We do seek your support. If you decide to contribute, we are a tax-deductible, 501-C-3 non-profit organization. Checks may be made payable to: AHRP

Vera Hassner Sharav
Alliance for Human Research Protection (AHRP)
142 West End Avenue, Suite 28P
New York, NY 10023

Tel: 212-595-8974

Newark Star Ledger

Antidepressant prescriptions show decline:
Drop follows FDA meeting on links to suicides in kids Tuesday, May 11, 2004

The number of new prescriptions written for antidepressants has dropped by 10 percent since a government meeting was held earlier this year to review suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during early February, when a Food and Drug Administration panel met to explore scientific data. The meeting drew national publicity when some parents told how their children attempted or committed suicide after taking of one of the drugs. Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were told to put warnings on product labels. As of April 23, the number of new prescriptions per week was about 996,000, according to NDC Health, a market research firm that tracks prescription data.

“Depression still exists. I see it in my office every day,” said Roy Boorady, an assistant psychiatry professor at New York University School of Medicine’s Child Study Center. “But in talking to my colleagues, I know we’ve all been more cautious prescribing these medications.”

The data also shows the total number of new and refilled prescriptions fell 6 percent over the same period, and is the latest indication that the controversy over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say antidepressants are life-savers, which helps explain why the drugs generated more than $11 billion in retail sales last year. But critics say the alleged links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing previously unpublished safety data from pharmaceutical companies, urged physicians not to prescribe most of the medicines to children. Their list included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an advisory panel in February. But after the meeting, the agency was criticized by consumer advocates for allegedly silencing its own medical reviewer, who wanted to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on product labeling and asked Columbia University researchers to review side effect data. A report is expected this summer. But the agency was chastised by angry parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA’s handling of its medical reviewer. The agency denied silencing the reviewer and defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee, said the agency’s action raised “troubling questions” and that he may hold hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs. Only Prozac was approved for children in the United States, but doctors can prescribe any medication. Drug makers are also under pressure to release unpublished clinical trial data, which critics say may contain negative information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@starledger.com.

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

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