Doctors and prescriptions:  Doctors of today are less inclined to research on their own, yet they are quite happy prescribing drugs, marketed by attractive Drug Representatives.  Apparently drug companies now hire cheerleaders as their drug representatives, a move of the desperate or the substandard.  Not to be obnoxious, but I knew a lot of cheerleaders at Syracuse University and know of which I speak, they are very cute and enthusiastic and yes, just a bit flirty.  Not really Mensa girls, I must admit.  I SERIOUSLY do not want a cheerleader persuading my Neurologist to prescribe her company's MS drugs to me.  I somehow become the least important part of this equation although I am the only one paying for any of it, his salary, her salary and each drug company's income.  I don't want him mesmerized by her legs while ignoring the fact these drugs cause FATAL SKIN REACTIONS in some patients. That means you DIE because of something crazy going on with your SKIN!!! 

As per the New York Times article By Stephanie Saul, 11/28/2005  "Anyone who has seen the parade of sales representatives through a doctor's waiting room has probably noticed that they are frequently female and invariably good looking. Less recognized is the fact that a good many are recruited from the cheerleading ranks. " NY Times Cheerleaders article

Here is a disturbing fact, Kaopectate was prescribed by many Doctors for children with diarrhea but it contained lead levels proven toxic to children.  Why would a company add toxic levels of a known carcinogen to a children's medication?

KAOPECTATE:  The Center for Environmental Health (“CEH”) filed suit in 2001 against Pharmacia Corporation, the makers of Kaopectate.  The suit cites extremely high levels of lead in Children’s Kaopectate without proper warning to parents or other consumers.  CEH alleges that Children’s Kaopectate exposes children to lead in quantities nearly 400 times higher than levels that legally require a warning.  These warnings are required under Proposition 65, California’s toxics right-to-know law.  In June 2003, Pharmacia Corp. settled their lawsuit and agreed to lower their LEAD levels.  Only after a lawsuit did this company attempt to protect its own consumers.  http://sanjose.bizjournals.com/sanjose/stories/2003/06/23/daily53.html - PLEASE make sure you read the lengthy WARNING inserts included with your prescriptions.

Lead is listed by the State of California as both a carcinogen and potent reproductive toxin, and is widely known for its devastating neurotoxic effects on child development, including brain damage, lowered IQs, and behavioral problems. By all means give lead to children for diarrhea, possibly causing irreversible brain damage, rather than offering bananas.

The FDA's latest Cautions for popular Medications

Multiple Sclerosis
Tysabri:  February 2005 -- the MS drug Tysabri was taken off the market after it killed a patient.  It had only been on the market for 4 months, obtaining its approval on the FDA's accelerated fast-track for the treatment of multiple sclerosis. It triggered a neurological condition called progressive multifocal leukoencephalopathy (PML) in two patients during a 2-year clinical trial. According to the The Wall Street Journal, "Fast-track approval, coupled with an absence of post-approval monitoring for adverse effects, has a high cost - often resulting in loss of lives."

Avonex:  March 16, 2005 -- Patients taking the multiple sclerosis (MS) drug Avonex should be watched for possible liver problems, according to the drug's maker, Biogen Inc.  According to the drug's web site:
"Your liver may be affected by taking Avonex and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor immediately."

Betaseron (interferon beta-1b) Berlex, Inc. reminded healthcare professionals of the prescribing information for Betaseron (interferon beta-1b) as it pertains to hepatic toxicity. Betaseron is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. There have been reports during post-marketing safety surveillance of serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Liver function testing is recommended at regular intervals (one, three, and six months) following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms. [April 15, 2005 - Letter - Berlex]

Cholesterol lowering

Crestor (rosuvastatin) FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. These risk factors and many of the recommendations for how to minimize the risk of myopathy are already captured in the FDA approved labeling for Crestor in the U.S. FDA alerted physicians to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.  [June 09, 2004 Public Health Advisory - FDA]

Arthritis and Pain medications

Humira (adalimumab) FDA and Abbott Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS section of the prescribing information, indicated for the treatment of rheumatoid arthritis. These warnings include serious infections with the combined use of Humira (adalimumab) and anakinra, hypersensitivity reactions, including anaphylaxis, and hematologic events, including pancytopenia and aplastic anemia. [November 05, 2004 - Letter - Abbott]

Celebrex (celecoxib) FDA notified healthcare professionals that, based on emerging information, including preliminary reports from one of several long term National Institutes of Health (NIH) prevention studies, the risk of cardiovascular events may be increased in patients receiving Celebrex. FDA is analyzing all available information from these studies to determine whether additional regulatory action is needed. [December 17, 2004 - Drug Information Page - FDA]

Vioxx (rofecoxib) Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.  Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.  [September 30, 2004 Public Health Advisory - FDA]

Steroids
Prednisone, cortisone ---  Have you ever wondered what happened to Jane Pauley?  Well, in 2001 Jane Pauley suffered a painful bout with hives and was prescribed Steroids by her doctor.  Soon after taking the medication, she began exhibiting manic episodes and was subsequently diagnosed as Bi-Polar or Schizophrenic.  Her condition was caused by a known side effect of the steroids, this one time use of steroids had caused her irreversible damage.  She spent weeks in a Psychiatric hospital and now takes Lithium on a daily basis, for life to control her Schizophrenia.    Here is her story: http://www.msnbc.msn.com/id/5887567/

According to The Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas 75235-9101:      "Corticosteroids are routinely prescribed for a variety of allergic and immunologic illnesses. Psychiatric side effects from corticosteroids include mania, depression and mood disturbances. Psychiatric symptoms usually occur within the first two weeks of corticosteroid therapy and seem to be dose related. Treatment with lithium or antipsychotics may be helpful. Physicians should carefully monitor patients for psychiatric and cognitive side effects of corticosteroid use." http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10619339

Birth Control
Depo-Provera (medroxyprogesterone acetate injectable suspension)  FDA and Pfizer notified healthcare professionals of the addition of a BOXED WARNING along with revisions to the WARNINGS, INDICATIONS AND USAGE, PRECAUTIONS and POSTMARKETING EXPERIENCE sections of the prescribing information to include information on the loss of significant bone mineral density. Depo-Provera Contraceptive Injection is indicated only for the prevention of pregnancy in women of child-bearing potential. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-Provera Contraceptive should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate. [November 18, 2004 - Dear Healthcare Professional Letter - Pfizer]

Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) [Posted 11/14/2005] FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills. [November 10, 2005 - News Release - FDA]

Attention Deficit Disorder and Depression
Strattera (atomoxetine) FDA notified health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered. Health care professionals are encouraged to report any unexpected adverse events associated with Strattera to Eli Lilly or to the FDA MedWatch program. [December 17, 2004 - Talk Paper - FDA]

Paxil (paroxetine hydrochloride) Tablets
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. [May 2004 Letter - GlaxoSmithKline]

Antidepressant Use in Children, Adolescents, and Adults    The FDA asked manufacturers of the following antidepressant drugs to include in their labeling a Warning statement that recommends close observation of adult and pediatric patients for worsening depression or the emergence of suicidality when treated with these agents. The drugs that are the focus of this new Warning are: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine). [March 22, 2004 Public Health Advisory - FDA]

Wellbutrin (bupropion hydrochloride) Tablets
Wellbutrin SR Sustained-Release Tablets Wellbutrin XL Extended-Release Tablets
FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. [May 2004 Letter - GlaxoSmithKline]

Adderall XR (amphetamine)
FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old with ADHD, and Adderall, the immediate release formulation of the drug, is approved for pediatric patients with ADHD. [February 10, 2005 - Drug Information Page - FDA]

Asthma, OTC Pain Relief, Dry Skin, Erectile Dysfunction, Antibiotic, Weight loss and Diabetes
Long-acting Beta2-Adrenergic Agonists:
Advair Diskus (fluticasone propionate & salmeterol inhalation powder)
Foradil Aerolizer (formoterol fumarate inhalation powder)
Serevent Diskus (salmeterol xinafoate inhalation powder)FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled. [November 18, 2005 - Public Health Advisory - FDA]