Posts Tagged ‘Warnings’

Paxil Birth Defects Lawyers Site Offers News And Information About Antidepressant Heart Defects

Monday, September 27th, 2010
Quote startDespite evidence suggesting that Paxil could cause birth defects, Glaxo deliberately chose not to conduct studies that would have uncovered the true dangers of the drug.Quote end

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy. Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects.

PR WEB

September 27, 2010

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy.

Paxil is part of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). After it first went on the market in December 1992, Paxil has gone on to become one of the most widely prescribed drugs in the United States, with annual sales of $3.2 billion by 2002.

Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects. In December 2005, the Food and Drug Administration called for stronger birth defects warnings on the drug’s labeling after two studies found that Paxil doubles the risk of birth defects when taken by women during the first trimester of pregnancy. Most of these birth defects involved cases of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

Paxil has also been linked to an increased risk of birth defects when taken later in pregnancy. A 2006 study published in the New England Journal of Medicine found that women who take Paxil or similar antidepressants after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), a condition which causes breathing and circulation problems that may lead to hospitalization or death.

Taking Paxil during pregnancy may also be linked to a number of other serious heart defects in newborns, including cardiomyopathy, tricuspid stenosis, cleft mitral valves, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valves or patent ductus arteriosus (PDA).

Documents uncovered in the ongoing litigation against GSK [Paxil] products liability litigation (MDL-1574)] have revealed that GlaxoSmithKline, the drug’s manufacturer, was aware of the potential link between the antidepressant and birth defects as early as 1980, but failed to recall the drug or properly warn about its dangers until these risks were made public by researchers.

“Despite evidence suggesting that Paxil could cause birth defects, GlaxoSmithKline deliberately chose not to conduct studies that would have uncovered the true dangers of the drug,” says David Friend of Hissey Kientz, LLP. “It is impossible to say how many lives were drastically altered because of the company’s failure to heed the advice of experts and investigate the link between Paxil and birth defects.”

Read the rest of the article here: http://www.prweb.com/releases/2010/09/prweb4565144.htm

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Chantix & Violence: What Patients Have In Common

Thursday, July 22nd, 2010

Pharmalot
By Ed Silverman
July 22, 2010

For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this). The FDA subsequently imposed a risk management program and Pfizer added warnings.

Now, a new study in The Annals of Pharmacotherapy finds Chantix is not only associated with violent and agressive thoughts and acts, but has also identified some of the common characteristics among people using the pill and their subsequent behavior. The drug “does have warnings about psychiatric side effects, but it skims over aggression/violence towards others to focus mainly on suicidal behaviors,” says Thomas Moore, one of the co-authors and a senior scientist at the Institute for Safe Medication Practices, a non-profit that has issued reports previously about Chantix side effects.

“We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”

The researchers obtained 78 adverse event reports from the FDA MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; four more cases came from clinical trials, and three others came from published literature. Ultimately, they used 26 case reports for study and these described 10 events with assault, nine cases of homicidal ideation and seven instances of other thoughts or acts of aggression/violence. They noted that the patient population was predominantly middle-aged women, but “an unlikely age group and sex for assault and acts of violence toward others.”

“In all 26 cases,” they write, “the acts or thoughts of violence appeared to be inexplicable and unprovoked. A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a young granddaughter also present. A 42-year-old man punched a stranger at a bowling alley. The stranger and two friends responded and knocked out the subject’s front teeth. A 24-year-old female started beating her boyfriend in bed because he “looked so peaceful” and she later attempted suicide. A 29-year-old female struck an acquaintance twice in the face, and then started smashing doors in her own home and beating on her truck.”

Read entire article:  http://www.pharmalot.com/2010/07/chantix-and-violence-what-patients-have-in-common/

*The package insert for Chantix shows that it contains a type of chemical compound that is better known as benzodiazepine—benzodiazepines are otherwise known as anti-anxiety drugs.

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SSRIs Render Unfriendly Skies—FOIA documents reveal what FAA failed to consider in allowing pilots on antidepressants to fly

Wednesday, July 14th, 2010

Scoop Independent News
By Evelyn Pringle
July 14, 2010

The SSRI antidepressant makers are desperate to find new customers, so they recently have been focusing on capturing groups for which the drugs were usually considered off limits. The latest marketing coup managed to open up sales to roughly 614,000 American pilots.

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories’ Celexa and Lexapro.

“The FAA should reverse its ruling before it’s too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent–or just loses his sharpness–under the influence of antidepressant medication,” said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and “deliberately descended below the minimum descent altitude.” The plane stalled and crashed while circling after an aborted landing.

“Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach,” the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time,” before beginning a commentary in which he told passengers: “If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees.”

A review of medical records documented that “from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft),” the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked “chemical imbalance in the brain” theory when writing: “All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain.”

“Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants,” the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

“Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence,” according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person.

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, “Seroxat Sufferers,” sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after “careful consideration.” However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view. Like Peter Breggin for instance.

The FAA’s response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for “minutes of meetings where the change in the policy was on the agenda,” as well as a list of “members present and a declaration of interests of each of the members,” the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants “unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe.” But the “unanimous consensus” was that only Prozac and Zoloft “were appropriate medications due to the longevity of their use and overall safety.”

“They also felt that only these two should be considered initially, and no other medications considered at this time,” the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the “new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.”

In response to a request for any information “given to FAA from outside parties that relate to the FAA’S recent change in policy regarding pilots on antidepressant medication,” the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

“In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain,” the response said. “We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.”

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, “Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents,” led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the “Aviation, Space, and Environmental Medicine” journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in “Aviation International News,” on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

“In 124 of those accidents, 211 people were killed,” Thurber said. “In accident after accident, antidepressants … were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems.”

Read the rest of this article here:  http://www.scoop.co.nz/stories/HL1007/S00116.htm

Read FOIA documents here: http://fiddaman.blogspot.com/p/faa-respond-to-freedom-of-information.html

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Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

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Jury recommends major reforms in drug prescribing after investigation of 18-year-old’s suicide under the influence of Paxil

Wednesday, June 30th, 2010

Pharmalot
By Ed Silverman
June 30, 2010

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

Read entire article:  http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/

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Science Daily: Almost 1/3 of U.S. nursing home residents received antipsychotic drugs as chemical restraints

Wednesday, June 2nd, 2010

Illinois Nursing Home Abuse Blog
By Levin & Perconti

Science Daily is reporting that a study shows that newly admitted elderly patients to nursing homes have a higher rate of being prescribed antipsychotic drugs than in previous years. This study found that in 2007, almost one-third of U.S. nursing home residents received antipsychotic drugs. The FDA has issued a warning that there is a great risk of death among older adults with dementia who are taking these agents to control behavioral symptoms. A recent clinical trial has concluded that the adverse effects of atypical antipsychotic drugs have outweighed the benefits of those with Alzheimer’s. This shows that many doctors are over prescribing these drugs, and it is having an adverse effect on patients.

The nursing home study found that about 30 percent of the residents in the study received at least one antipsychotic medication in 2006 and 32 percent of those did not have dementia or another indication that they needed to be on this medication. Some experts believe that the organizational culture of the nursing homes may encourage the prescribing of antipsychotic. Hopefully, the FDA warning and other studies will move the prescription statistics in the opposite direction. If not policies may have to target those nursing homes that have a high antipsychotic prescription rate so as to improve patient care. To read more about the nursing home study, please click the link.

Read entire article:  http://blog.levinperconti.com/2010/05/antipsychotic_medications_are.html

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FDA misleads again: Admits SSRI/suicide link for 25 & under but not adults

Thursday, August 13th, 2009

Julie Steenhuysen
Reuters
August 11, 2009

* Antidepressants raise suicide risks in young adults

* Older adults not affected, US FDA regulators find

CHICAGO, Aug 11 (Reuters) – People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.

The report by the FDA scientists confirms earlier studies and supports the agency’s age-related warnings on the drugs’ labeling.

U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.

In February 2005, the FDA added a so-called black box warning — the agency’s strongest warning — on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.

Read entire article: http://www.reuters.com/article/latestCrisis/idUSN11535486

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INFORMED CONSENT: How to make sure you’re getting quality medical care

Monday, August 3rd, 2009

Informed ConsentBy Moira Dolan, M.D.
August 3, 2009

Quality of health care is a big topic these days; with the majority of news stories covering how we are all going to get our hospital bills paid and our prescriptions filled. But there is a conspicuous absence of any discussion of over-treatment and the over-selling of false diagnoses and dangerous prescription drugs.

It is the responsibility of you, the consumer, to find out about the diagnosis, tests and treatments that are offered. Once you have full information, you can make decisions about accepting it, or not. This is called Informed Consent.

When you are given a diagnosis you need to know the actual physical evidence for it. You don’t want someone’s opinion if you have cancer, do you? You want to know what the biopsy showed under the microscope.

In the case of medications, the minimum your doctor should tell you is based on the information made generally available by the drug manufacturers. However, you should expect that your doctor is aware of any pertinent medical issues beyond what the pharmaceutical companies tend to provide.

This is the minimum your doctor should explain:

What is the evidence for the diagnosis?
How does the treatment affect the body?
How does the treatment affect the mind?
What unwanted effects may occur?
Is it approved by the FDA for your condition?
What is known and not known about how safe it is and how well it works?
What are the alternatives, including the option of no treatment?
Does your doctor or the clinic have a financial interest in pushing the diagnosis or treatment?

You can make your doctor work for you. Demand information and get key questions answered. Doctors are supposed to give every bit of this full information to each patient they diagnose, test, operate on or prescribe for. In fact, they are required to do so by federal guidelines, state statutes and medical society ethics codes.

Your role in the process is to get any questions answered. Then you can carefully consider the information you have been given. You may feel more comfortable taking the information home before making a decision about agreeing to the proposed treatment.

Be a part of the decision-making process when your doctor offers a drug:

Get a thorough understanding of what he or she is prescribing and why.

Ask exactly what the drug is and why it has been chosen for your condition. How does it work?

Find out if it is new on the market. If so, why was it chosen over older drugs?

Find out if the drug is safe to take:

How will this drug interact with your other medications or over-the-counter drugs or natural remedies you are taking?

What does your doctor personally know about the safety of the drug? How long was it tested? How long were patients followed after taking it to determine if they developed bad effects? Has the FDA published any reports of adverse effects?

Why is a new drug being prescribed instead of an older similar drug with a proven safety record?

Ask about how well it works:

Has the proposed drug been proven to be effective for your particular condition?

What is the drug effectiveness in comparison to no treatment; in comparison to older drugs; in comparison to alternate drugs; in comparison to non-drug treatments such as diet, rest, and vitamins; in comparison to herbal or natural remedies?

If your doctor provides any of the following answers, it should give you strong reservations about accepting the diagnosis or taking the drug:

There is only a checklist of symptoms or other peoples’ opinions to make the diagnosis. There is no abnormality of blood, tissue or biochemistry that can be shown to you.

Your doctor is unclear about the mechanism of action of a drug (what it is doing inside the body). Either the mechanism is not known and only guessed at, or your doctor doesn’t understand it.

The drug was approved within the last two years. Thus it lacks an extensive safety record in the general population.

Your doctor doesn’t know of any adverse effects aside from what he reads along with you in the package insert. Since your doctor has not looked at the FDA website of adverse drug events he or she knows of no warnings to give you. This is something you will have to question carefully to see if your doctor is saying, “I know there are no special warnings to give you” or if your doctor is actually expressing, “I don’t know of any special precautions (because I haven’t bothered to look, all my data comes from the manufacturer’s glossy brochures).”

Your doctor is writing with a drug-maker emblazoned pen, jotting on a note pad sporting the logo of the drug manufacturer or carrying a coffee mug advertising the latest. These are indications of a heavily drug salesman-infiltrated office, and may well reflect an inordinate reliance on sales talk in the absence of careful review of the scientific pharmacologic information.

The drug is a look-alike version of an older drug. This is offered to you at much greater expense without obvious medical advantage.

On occasion your doctor may have to honestly say, “I don’t know, I’ll go find out some answers for myself and for you.” However, be alert if your doctor is offended or becomes patronizing. In that case you can expect that you have tread into some areas in which he or she feels challenged or uncomfortable, and may not be ready to be thoroughly frank with you. Then again, sometimes the answer to these questions remains some version of, “I don’t know about the details of safety and effectiveness,” but he or she still feels you should take the drug. In this case you will have to carefully consider the unknowns and make your decision.

You can only really be in charge of the quality of your health care when you have the opportunity for full informed consent.

©Moira Dolan, M.D.

Reproduced by permission of the author.

Moira Dolan, M.D. is an internal medicine physician and executive director of Medical Accountability Network, LLC, dedicated to establishing integrity in medicine.

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