Tony Pantalleresco Radio Show notes – Show of the Month February 9 2013

Tony Pantalleresco

Show of the Month February 9 2013

The Drug Regulatory Agency Warnings on Psychiatric drugs and violence

Antidepressant Birth Defect Drug Warnings

Antidepressant Studies

Supplements with aloe vera may slash cholesterol levels by over 40%, suggests a new study with lab rats

Eczema in Infants Linked to Gut Bacteria

Caloric Restriction Has a Protective Effect On Chromosomes

Health Canada Approves Bio-K+® as a New and Effective Mean for the Reduction of Clostridium difficile Infections in Hospitals


The Drug Regulatory Agency Warnings on Psychiatric drugs and violence:

United States, November 2005: The FDA’s Safety Information and Adverse Event Reporting Program reported “homicidal ideation“ as an adverse event of Effexor ER (extended release).

Source: “Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — November 2005,” FDA MedWatch, November 2005.

United States, March 22, 2004: The FDA Public Health Advisory was issued, on antidepressants stating: “Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement, mild mania] and mania [psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been reported in adult and pediatric patients being treated with antidepressants.”


United States, October 1995: The U.S. Drug Enforcement Administration (DEA) said Ritalin use could lead to addiction and that “psychotic episodes, violent behavior and bizarre mannerisms had been reported” with its abuse.

Source: “Methylphenidate,” U.S. Drug Enforcement Administration (DEA), October 1995.

United States, June 28, 2005: The FDA announced its intention to make labeling changes for Concerta and other methylphenidate (Ritalin) products (stimulants) to include, “psychiatric events such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.” The FDA announced its intention to also investigate possible cardiac concerns with these drugs.

Source: “Statement on Concerta and Methylphenidate for the June 30 PAC”, Food and Drug Administration (FDA), June 2005.

Canada, February 2006: Health Canada approved a new warning label for Paxil that read, in part: “A small number of patients taking drugs of this type may feel worse instead of better. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts, such as thoughts of self-harm or harm to others.“ Health Canada required Paxil’s product information to detail a list of “rare” side effects, affecting fewer than one in 1,000 patients. These include delusions, hostility, psychosis, and psychotic depression.

Source: Kate Jaimet, “’I’ve learned a lesson in the worst way possible’: What drove a loving father to kill his son?,” Ottawa Citizen, 27 Aug. 2006.

Canada, June 03, 2004: Health Canada issued an advisory to the public that stated that stronger warnings have been placed on antidepressants. These warnings indicate that people taking these drugs at any age are at greater risk of behavioral or emotional changes including self-harm or harm to others. The advisory said, “A small number of patients taking drugs of this type may feel worse instead of better…. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.”

Source: Jirina Vlk, “Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants,” Health Canada, 2004-31, June 3, 2004.

Japan, May 2009: The Japanese Ministry of Health, Labor and Welfare investigated news reports of antidepressant users “who developed increased feelings of hostility or anxiety, and have even committed sudden acts of violence against others.” After its investigation, the Ministry decided to revise the label warnings on newer antidepressants stating, “There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication.”

Source: “Japan Revises SSRI Warnings–Hostility, Violence,” Medical News Today, May 28, 2009.

European Union, August 19, 2005: The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child antidepressant use as recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP). Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.

Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.

Australia, February 2009: The Australian Therapeutic Goods Administration reported that a boxed warning (the strongest warning) was placed onto the ADHD psychostimulant drug methylphenidate (Concerta and Ritalin) for drug dependence. It warns that chronic abuse of methylphenidate can lead to a marked tolerance and psychological dependence with varying degrees of abnormal behavior and frank psychotic episodes can also occur.

Source: “Boxed Warning, Contraindications and strengthened Precautions for Methylphenidate,” Janssen-Cilag, February 2009.

Australia, December 2004: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin recommending that any use of SSRI antidepressants in children and adolescents should be carefully monitored for the emergence of suicidal ideation. In a recent study involving Prozac, it said, there was an increase in adverse psychiatric events of suicide, self-harm, aggression and violence.

Source: “Use of antidepressants in children and adolescents,” The Australian Therapeutic Goods Administration (TGA) published an Adverse Drug Reactions Bulletin, Vol 23, No. 6, Dec. 2004, p. 22.

United States, July 01, 2009: The FDA has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban, aka the antidepressant Wellbutrin) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

Source: “Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics),” FDA, July 1, 2009.

United Kingdom, March 2009: Medicines and Healthcare products Regulatory Agency (UK) published in their Drug Safety Update newsletter new information about Atomoxetine (Strattera, a non-stimulant ADHD drug). They warned that Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children without a history of such disorders.

Source: Medicines and Healthcare products Regulatory Agency, Drug Safety Update newsletter, Vol. 2, March 8, 2009.

Australia, December 2008: The Australian Adverse Drug Reactions Bulletin published an article about the psychostimulant Modafinil. The bulletin advised that this drug has been reported to cause serious adverse skin and psychiatric reactions including anxiety, hallucination, aggression, and mania.

Source: Adverse Drug Reactions Advisory Committee, Australian Adverse Drug Reactions Bulletin, Vol. 27, No. 6, December 2008.

European Union, November 20, 2008: Eli Lilly included in their Strattera label in Europe warnings that Strattera causes “hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania…” Strattera is an antidepressant prescribed as a “non stimulant” drug to treat ADHD.

Source: “Official warnings issued: The ADHD drug Strattera CAUSES psychosis, hallucinations, mania and agitation” TransWorldNews, November 20, 2008.

United States, September 2007: The Vice President of Medical Services at the drug company Cephalon sent out a letter to health care professionals informing them of new warnings for the company’s psychostimulant Provigil. “Updated Safety Information: Warnings regarding serious rash, including Stevens Johnson Syndrome [a life-threatening condition affecting the skin] and hypersensitivity reactions, and psychiatric symptoms (including anxiety, mania, hallucinations, and suicidal ideation). 1. Provigil can cause life-threatening skin and other serious hypersensitivity reactions… 2. Provigil is not approved for use in pediatric patients for any indication. 3. Provigil can cause psychiatric symptoms.”

Source: Jeffrey M. Dayno, M.D., “Dear Healthcare Professional,” Cephalon, September 2007.

United States, February 21, 2007: The FDA directed ADHD drug manufacturers to distribute “patient friendly” guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs. The psychiatric adverse events included hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

Source: “FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events,” FDA News, February 21, 2007.

United States, August 21, 2006: The FDA said that ADHD drug manufacturers have to strengthen their warning labels to warn that the drugs can cause suppression of growth, psychosis, bipolar illness, aggression, and ‘serious’ cardiovascular side effects, including misuse possibly leading to sudden death from heart attacks and strokes. Psychostimulant drug companies GlaxoSmithKline and Shire posted a letter to doctors about the revised prescribing information.

Source: “UPDATE 2-US FDA calls for new warnings on ADHD drugs”, Reuters, August 21, 2006.

European Union, April 25, 2005: The European Medicines Agency’s scientific committee, the Committee for Medicinal Products for Human Use, concluded that Prozac-type antidepressants were associated with increased suicide-related behavior and hostility in young people. The London-based watchdog said it recommended the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks and that the drugs should not be used in children and adolescents in off label situations.

Source: “EU calls for tougher warnings on antidepressants for kids” April 25, 2005.

United Kingdom, September 21, 2004: The British Healthcare Products Regulatory Authority advised that it had issued guidelines that children should not be given most SSRI antidepressants because of clinical trial data showing an increase rate of harmful outcomes, including hostility.

Source: “Antidepressant aggression concern,” BBC News, 21 Sept. 2004.

European Union, April 22, 2004: The European Agency for the Evaluation of Medicinal Products issued a press release to the press and public. In this press release, they reported that, according to clinical trials, Paroxetine (Paxil in the U.S.) containing medicines could cause suicidal behavior and hostility in children. It recommended that Paroxetine not be used in children and recommended that young adults be observed carefully for signs and symptoms of suicidal behavior or hostility. Paroxetine was shown to have little effectiveness in children according to clinical trials. The committee also recommended strengthened warnings on the withdrawal symptoms of paroxetine, which are common.

Source: “European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products 20-22 April 2004″ EMEA, The European Agency for the Evaluation of Medicinal Products, Press Release April 2004.

Canada, August 22, 2003: Wyeth Pharmaceuticals, the makers of the antidepressant Effexor, issued a warning to U.S. and Canadian doctors that use of this drug could cause hostility, suicidal ideation and self-harm in patients under the age of 18.

Source: Wyeth Pharmaceuticals, “Dear Health Care Professional…” Health Canada, Health Products and Food Branch, August 22, 2003.

United States, May 2007: The FDA’s MedWatch system published a warning on the psychostimulant Desoxyn which is used for ADHD stating that the drug could cause: sudden death with pre-existing structural cardiac abnormalities or other serious heart problems, psychiatric adverse avents including aggression and the emergence of new psychotic or manic symptoms, long-term suppression of growth, seizures, visual disturbance, as well as serious cardiovascular adverse event.

Source: Food and Drug Administration (FDA), “Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)”, MedWatch, May 2007


Antidepressant Birth Defect Drug Warnings:

There have been 15 drug regulatory agency warnings from seven countries (United States, United Kingdom, Ireland, Canada, Australia, New Zealand, and Germany), showing how antidepressants have been tied to birth defects, listed below:

United States, December 14, 2011: The FDA notified healthcare professionals and the public about the use of selective serotonin reuptake inhibitor (SSRI) antidepressants, by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). Source: “Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn” FDA, December 14, 2011,

United States, April 01, 2011: The FDA issued label changes to the antidepressant Prozac to warn of the potential risk of cardiovascular defects in infants exposed during first trimester of pregnancy. In addition, the following side effects were added to the “Adverse Reaction” section: balance disorder, bruxism (habitual grinding of teeth), gynecological bleeding, hypotension (low blood pressure), alopecia (hair loss), dysuria (painful urination), micturition (urination) disorder and depersonalization. Source: “Prozac (fluoxetine hydrochloride), Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)” FDA, April 2011,

New Zealand, September 01, 2010: MedSafe (NZ) issued information in their Prescriber Update publication about the use of antidepressants during pregnancy. The Medicines Adverse Reactions Committee (after reviewing studies on two types of antidepressants – SSRIs and SNRIs) concluded that there is a small increased risk of heart birth defects associated with fluoxetine (Prozac), similar to that seen with Paroxetine (Paxil). Also, there is a possibility of this increased risk for all SSRIs or SNRIs antidepressants (not just Paxil and Prozac). In addition to the risk of birth defects, SSRIs and SNRIs antidepressants have been associated with an increase in risk of pre-term birth, persistent pulmonary hypertension (little or no blood flow enters into an infants lungs after birth) and newborn withdrawal symptoms. Source: “The use of antidepressants in pregnancy,” Prescriber Update, MedSafe, Vol. 31, No. 3, Sept. 2010.

United Kingdom, May 01, 2010: The UK’s Medicines and Healthcare products Regulatory Agency issued a warning about the use of SSRIs (selective serotonin reuptake inhibitor) antidepressants in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension, where there is a defect in the newborns arteries causing little or no blood flow to enter the lungs after birth. Source: “SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn,” Drug Safety Updates, Medicines and Healthcare products Regulatory Agency, Vol. 3, Iss. 10, May 2010, p. 2.

United Kingdom, March 2010: The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published in their Drug Safety Update a warning that there was an increased risk of heart birth defects with the use of the antidepressant fluoxetine (Prozac) in the first three months of pregnancy, similar to that seen with paroxetine. Source: “Fluoxetine: possible small risk of congenital cardiac defects,” Drug Safety Updates, Medicines and Healthcare products Regulatory Agency, Vol. 3, Iss. 8, March 2010.

Ireland, March 2010: The Irish Medicines Board published in there Drug Safety Newsletter, a report warning about the increased risk of heart birth defects and the use of fluoxetine (Prozac) in the first three months of pregnancy. This was based on the European Medicines Agency analysis of the subject, which included nine studies. They found that the risk of having a baby born with a cardiovascular birth defect following the use of fluoxetine during the first trimester is slightly increased. Source: “Fluoxetine and risk of cardiovascular birth defects,” Drug Safety, Irish Medicines Board, Iss. 36, March 2010.

United States, July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took newer antidepressants during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension (a heart and lung disorder) in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels. Source: Susan Heavey, “U.S. FDA warns of new antidepressant risks,” Reuters, July 19, 2006.

Germany, May 08, 2006: The German Drug Regulatory Agency (BfArM) issued risk information on the newer antidepressant Paroxetine (Paxil), that it increased the risk of cardiac malformation in newborns when the mother took Paroxetine during her pregnancy. All German drug manufacturers producing Paroxetine drugs were ordered to implement the warning and safety notes on their drug information leaflets. Source: “Questions and answers on Paroxetine,” Risk information of the BfArM, May 8, 2006.

Canada, March 10, 2006: Health Canada issued an advisory warning for antidepressant use in pregnant women. Research shows newer antidepressants may increase risk of a serious lung disorder in newborns. The warning applies to all newer antidepressants including Wellbutrin, Celexa, Cipralex, Prozac, Luvox, Remeron, Paxil, Zoloft, Effexor, Zyban. Source: “Newer antidepressants linked to serious lung disorder in Newborns” Health Canada, March 10, 2005.

Canada, February 25, 2006: Health Canada issued an advisory to the press regarding newer antidepressants being linked to serious lung disorders in newborns. Health Canada advises that pregnant women taking newer antidepressants should discuss the situation with their doctor because of the potential risk to the baby. Source: “Advisory – Newer antidepressants linked to serious lung disorder in newborns” CNW Group, February 25, 2006.

Canada, December 16, 2005: Health Canada issued Important Safety Information on Paxil, publishing GlaxoSmithKline’s letter to healthcare professionals about a Swedish study that had found heart malformations in newborns of mothers taking Paxil during their first trimester. “Due to the potential for discontinuation symptoms, doctors should inform patients that the drug should not be stopped without first discussing it with their doctor,” the letter further states. Source: “New Safety Information Regarding Paroxetine: Second Large Study Shows an Increased Risk of Cardiac Defects, Over Other Antidepressants, Following First Trimester Exposure to Paroxetine” Health Canada, December 16, 2005.

United States, December 08, 2005: The FDA issued a Public Health Advisory that warned physicians about the potential risk to the fetus if they prescribed Paxil to pregnant women in their first trimester. The drug may cause birth defects, including heart malformations. Source: “FDA Public Health Advisory Paroxetine” Food and Drug Administration (FDA), December 8, 2005.

Canada, September 29, 2005: GlaxoSmithKline, after discussions with Health Canada, issued a letter to healthcare professionals advising of a change to their prescribing information stating that Paxil is associated with an increase of congenital malformations when used by pregnant women. Source: “Important Prescribing Information,” GlaxoSmithKline, September 2005.

United States, September 27, 2005: The FDA and GlaxoSmithKline issued a warning that showed a recent study the drug company conducted on 3,581 pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy. They found an increased risk of major congenital [defect at birth] and cardiovascular [heart] malformations at birth for those mothers taking Paxil. The most common defect was malformations between the heart’s two main pumping chambers. Paxil’s website also said, “Babies born to mothers who have taken antidepressants, including newer ones such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, shakiness, irritability or constant crying…There have also been reports of premature births in pregnant women exposed to SSRIs [newer antidepressants], including Paxil.” Source: Miranda Hitti, “New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants” WebMD, September 27, 2005.

Australia, September 07, 2005: The Australian Therapeutics Goods Administration issued an information sheet to health professionals warning that use of newer antidepressants-especially Paxil-in early pregnancy could cause congenital heart abnormalities in newborns. It reported that Danish researchers had determined an association in the first trimester of pregnancy. Source: “General information concerning use of SSRI antidepressants in pregnant women” Australian Government, Department of Health and Aging, September 7, 2005.


Antidepressant Studies:

There have been 18 studies in eight countries (United States, United Kingdom, Australia, Canada, Netherlands, Finland, Denmark and Sweden), which found a connection between antidepressants and birth defects listed below:

Nordic Countries, January 12, 2012: A study published in the British Medical Journal looked at 1.6 million infants born between 1996-2007. The authors found that mothers who used SSRIs late in pregnancy increased the risk of their child being born with a birth defect effecting breathing, known as persistent pulmonary hypertension. This increased risk was more than two folds. Source: Helle Kieler, Miia Artama, Anders Engeland, Orjan Ericsson, Kari Furu, Mika Gissler, Rikke Beck Nielsen, Mette Norgaard, Olof Stephansson, Unnur Valdimarsdottir, Helga Zoega, Bengt Haglund, “Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries,” British Medical Journal, Vol. 344, Jan 12, 2012.

Finland, July 01, 2011: The journal Obstetrics & Gynecology published a Finnish population-based study of 635,583 births, where 6,976 (1.1%) of the fetuses were exposed to SSRIs (newer antidepressants) during their first trimester. The authors found “that exposure to fluoxetine (Prozac) and Paroxetine (Paxil) in early pregnancy is associated with a small but established risk of specific cardiovascular anomalies [heart defects]…” Source: Heli Malm, MD, PhD, Miia Artama, MSc, PhD, Mika Gissler, MSocSc, PhD, and Annukka Ritvanen, MD, “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies,” Obstetrics & Gynecology, Vol. 118, No. 1, July 2011.

Denmark, June 23, 2010: A study in BioMed Central, Ltd., showed how the prescribing of psychotropic drugs in infants is rapidly increasing. In attempts to curb the use of these drugs, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. This team of researchers analyzed data submitted to a national adverse drug reactions (ADR) database to categorize ADRs reported for psychiatric drugs in the Danish pediatric population. They found that almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents. The authors concluded that, “The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women.” Source: Lise Aagaard and Ebba H Hansen, “Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade,” BioMed Central Ltd., vol. 3, no. 176, June 23, 2010.

Australia, May 01, 2010: A study in Australian and New Zealand Journal of Psychiatry looked at whether newborn outcomes, including age at birth, growth at birth and then at 1 month, were altered by exposure to antidepressants during pregnancy. They found that antidepressant exposure during pregnancy resulted in an eightfold increase in chance of being born premature, and with a smaller birth weight. This association was not found with depressed mothers. In addition, at 1 month in age, the difference in weight in the exposed group became significantly greater then those not exposed to antidepressants. Source: Andrew J. Lewis, et al, “Neonatal growth outcomes at birth and one month postpartum following in utero exposure to Antidepressant medication,” Australian and New Zealand Journal of Psychiatry, Vol. 44, No. 5, May 2010.

Canada, April 26, 2010: The American Journal of Obstetrics and Gynecology published a study that researched whether maternal bupropion (an antidepressant) treatment in early pregnancy is associated with birth heart defects in the infant. They found that mother’s of infants with left outflow tract heart defects were more likely to have reported taking bupropion. The authors concluded that there is an association between early pregnancy bupropion use and left outflow tract heart defects. Source: Alwan S, Reefhuis J, Botto LD, et al., “Maternal use of bupropion and risk for congenital heart defects.” American Journal of Obstetrics and Gynecology, Volume 203, Issue 1 , Pages 52.e1-52.e6, July 2010.

Denmark, March 01, 2010: The journal Pediatrics published a study that investigated the possible association between antidepressant exposure (including Paxil) to the fetus during pregnancy and normal milestone developments at 6 and 19 months. Their concluding research found that exposure to antidepressants affected fetal brain development. Source: Lars Henning Pedersen, MD, et al., “Fetal Exposure to Antidepressants and Normal Milestone Development at 6 and 19 Months of Age,” Pediatrics, Vol. 125, No. 3, March 3, 2010.

Sweden, January 05, 2010: Authors of a study published in Psychological Medicine investigated possible adverse effects of the use of antidepressant medication during pregnancy. They reviewed 14,821 women from the Swedish Medical Birth Register. The researchers found that there was an association between antidepressant treatment and many pregnancy complications, notably after tricyclic antidepressant use. An association between use of Paroxetine (Paxil) and birth heart defects and urinary tube defects was also found. The authors concluded that women using antidepressants during pregnancy and their newborns have an increase in health issues. Source: M. Reis, and B. Kallen, “Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data,” The Psychological Medicine, 1-11, [Epub ahead of print], Jan. 5, 2010.

United States, January 01, 2010: A study published in the Current Drug Delivery researched the “under evaluated” impact of antidepressant use during pregnancy on the risk of spontaneous abortion. After reviewing the data collected, they said the information suggests fetal exposure to antidepressants, especially Paroxetine (Paxil) and venlafaxine (Effexor), can lead to spontaneous abortion. Source: Broy, Perrine and Berard, Anick., “Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review,” Current Drug Delivery, Vol. 7, No. 1, January 2010.

United States, December 01, 2009: A study in the American Journal of Obstetrics & Gynecology looked at the effects of psychiatric drugs taken during pregnancy on fetal outcomes. It found that Selective serotonin receptor inhibitors (SSRIs – newer antidepressants) were associated with preterm deliveries when women started treatment after the first trimester. The researchers recommend more studies about risks and benefits of psychotropic medication use during pregnancy. Source: Ronit Calderon-Margalit, MD, MPH, et al., “Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy” American Journal of Obstetrics & Gynecology, Vol. 201, Iss. 6, Page 579, December 2009.

United Kingdom, September 23, 2009: A study published in the British Medical Journal reviewed the chances of SSRIs (newer antidepressants) causing birth defects when taken during pregnancy. The authors found a significant increase in risk of septal (the muscle wall that divides the heart chambers) heart defects among children who’s mothers took SSRIs during pregnancy, particularly with sertraline and citalopram. This risk nearly doubled when more then one SSRI was taken. Source: Lars Henning Pedersen, et al, “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study,” British Medical Journal, Vol. 339, September 23, 2009.

Canada, September 01, 2009: The journal Current Drug Safety published a study that found when pregnant women used Paroxetine (Paxil) during the stage in pregnancy when their baby’s organs are being developed, there was a connection to the increased risk of heart malformations. Source: Simoncelli M, Martin BZ, Brard A, “Antidepressant Use during Pregnancy: A Critical Systematic Review of the Literature,” Current Drug Safety, September 1, 2009.

Netherlands, August 14, 2009: The journal BJOG: An International Journal of Obstetrics & Gynaecology published a study that found children of mothers who used antidepressants during pregnancy showed increased healthcare use during the first year of life, independent of the mother’s healthcare use, and had an increased risk of major cardiac interventions such as cardiovascular surgery or heart catheterization in early childhood. Source: TF Ververs, et al., “Association between Antidepressant drug use during pregnancy and child healthcare utilization,” BJOG: An International Journal of Obstetrics & Gynaecology, August 14, 2009.

United States, October 24, 2007: A study presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry by Sheila Marcus, MD, found that babies born to mothers who take antidepressant drugs during pregnancy have high levels of cortisol (primary stress hormone) in cord-blood at birth, and their mothers are more likely to experience delivery complications. Source: Sheila Marcus, M.D., “Antidepressant Medication and Depression Status: Impact on Neonatal Outcomes,” presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry, October 24, 2007.

United States, June 28, 2007: A study published in the New England Journal of Medicine found that infants born to women taking commonly prescribed newer antidepressants during the first trimester of their pregnancies have a slightly higher risk of life-threatening birth defects. Source: Carol Louik, Sc.D., et al., “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects,” New England Journal of Medicine, Vol. 356, No. 26, June 28, 2007.

Canada, December 29, 2006: A new study published in Birth Defects Research Part B: Developmental and Reproductive Toxicology on Paxil, found that Paxil and other antidepressant use in pregnant women increased the possibility that their babies would be born with birth defects. Source: Roman Bystrianyk, “Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth Defects,” Health Sentinel, December 29, 2006 citing: Birth Defects Research Part B: Developmental and Reproductive Toxicology, December 2006.

Denmark, November 01, 2006: An Epidemiology study found that pregnant women who took newer antidepressants were more likely to have babies with birth defects than mothers who didn’t take these drugs. Source: Wogelius, Pia, Norgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et al., “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, November 2006.

Finland, July 15, 2003: A Finnish study published in the Archives of General Psychiatry found that infants whose mothers took newer antidepressants during pregnancy could suffer neurological problems during their first week of life. The symptoms included tremors, restlessness and rigidity. Source: “Newer Antidepressants Can Harm Newborns,” Connecticut Post, July 15, 2003.

United States, May 01, 1993: A study published in the Journal of the American Medical Association found that out of 117 mother who took fluoxetine (Prozac) during the first trimester had a 14.8% risk of miscarriage compared to 7.8% in mothers not exposed to fluoxetine or older antidepressants. There were 19 spontaneous abortions and 13 abnormalities, including heart and small intestine defects in the Prozac group. One baby was born with clubfeet, and a second with a congenital dislocation of the hip. In comparison, there were only 10 spontaneous abortions and 4 anomalies in the non-drug group. Source: Anne Pastuszak, BSc, et al., “Pregnancy Outcome Following First-Trimester Exposure to Fluoxetine (Prozac),” Journal of The American Medical Association, Vol. 269, No. 17, May 5, 1993.


Antidepressant Side Effects Reported to the FDA:

There have been 6,011 birth defects adverse reactions that have been reported to the US FDA’s Adverse Event Reporting System (MedWatch), between 2004 and 2011, these break down to:

3,386 cases of antidepressants causing heart problems
2,190 cases of antidepressants causing general birth defects
218 cases of a antidepressants causing lung and heart defect causing normal blood circulation failure
217 cases of antidepressants causing clubfoot


Supplements with aloe vera may slash cholesterol levels by over 40%, suggests
a new study with lab rats
The combination was also associated with similar significant reductions in triacylglycerol levels, and a 12% increase in HDL cholesterol levels, according to findings published in An optimized blend of the probiotic LGG and aloe vera gel could be exploited as a potential biotherapeutic remedy to decrease cholesterol levels and lower the risk of CVD, although the field is open for further studies wrote researchers led by Manoj Kumar, PhD, from India’s National Institute of Nutrition High cholesterol levels, hypercholesterolemia, have a long association with many diseases, particularly cardiovascular disease (CVD), the cause of almost 50 per cent of deaths in Europe and the USA recent report from the American Heart Study The Indian researchers divided lab rats into four groups: The first group acted as the control and was fed a normal diet; the other three groups were fed a hypercholesterolemic diet with supplemental LGG, Aloe vera gel, or a combination of both for 45 days Results showed that LGG consumption alone was associated with a 32% reduction in total cholesterol levels, and this increased to 43% when administered in combination with Aloe vera In addition to the improvements in triacylglycerol and HDL levels, the LGG Aloe vera combination was also associated with reductions in very low-density (VLDL) and low-density lipoprotein (LDL) of 45% and 30%, respectively “There has been a surge of interest in using phytometabolites for nutritional and health applications,” wrote the researchers.“The present study showed that probiotic-fermented milk alone or in combination with AV gel had a positive effect on the lipid profile in experimental animals, although the mechanisms involved warrant further investigations.
Special Note—any combo with aloe or yogurt or kefir —will have a profound effect on the intestinal and stomach health—aloe will effect– Aloe vera (consumed orally or applied topically) may inhibit various types of Detrimental Bacteria and Aloe vera (gel applied topically for long periods) may prevent Detrimental Bacteria from penetrating the Skin. references Bacteria inhibited by Aloe vera include: —Bacillus subtilis -Citrobacter species –Enterobacter cloacae Eschericia coli –Klebsiella pneumoniae –Mycobacterium tuberculosis –Propionibacterium acnes–Pseudomonas aeruginosa –Salmonella species –Serratia marcescens –Staphylococcus aureus—Streptococcus agalactiae –Streptococcus faecalis -Streptococcus pyogenes — Yogurt may stimulate the growth of Immune Cells to combat the Detrimental Bacteria within the Digestive Tract that cause Diarrhea. –May help to prevent Gastric Ulcers (due to the Lactobacillus acidophilus content of Yogurt inhibiting Helicobacter pylori, the Detrimental Bacteria that is implicated in Gastric Ulcers).- May stimulate the production of Antibodies (due to Beneficial Bacteria in Yogurt). May prevent some forms of Cancer–High consumption of Yogurt may help to prevent Breast Cancer. — May help to prevent Colon Cancer (due to Beneficial Bacteria in Yogurt detoxifying the Heterocyclic Aromatic Amines (HAAs) that may initiate Colon Cancer).–May inhibit the proliferation of Candida albicans (by recolonizing the Digestive Tract with Beneficial Bacteria). May inhibit the growth of Detrimental Bacteria in the Intestine (due to the presence of Beneficial Bacteria within the Digestive Tract)-May suppress the proliferation of Eschericia coli.- May inhibit Pseudomonas aeruginosa. May increase the resistance of the Digestive System to Salmonella infection. –Yogurt may suppress the proliferation of Staphylococci aureus Bacteria—=Yogurt may stimulate the Immune System. — Yogurt may lower serum Cholesterol levels by up to 30%-Yogurt may increase HDL Cholesterol levels.—Kefir-will as well provide beneficial bacteria as well as enzymes



(Please note that this is NOT a cure! It’s purely to assist your system to expel SOME of the fibres, thus reducing the load and resulting in some comfort.)

MUST WATCH: for a complete demonstration.

1. Aloe Vera Gel – 250ml (Aloe Vera penetrates up to 3 layers of skin)
2. Citric Acid – 1 Heaped Teaspoon
3. PURE powdered Aspirin (Salicyclic Acid) – 1/4 to half Teaspoon (Strips toxins off the skin & reduces inflammation on the skin)
4. Powdered Vit C – 15 grams (OR 1 to 3 HEAPED Teaspoons) Tony varies on this, but says it’s NOT as issue!
5. Only added LATER ~ AFTER blending the above 4 as recommended below: IODINE ~ DO NOT ADD NOW!

METHOD for mixing:
1: Blend the above first 4 ingredients together until evenly blended. (1 – 2mins depending on what method you choose to use.)
2. Remove from blender & pour into a PLASTIC lidded container / jar. (Not a metal lid)
3. Add 5th ingredient ~ IODINE (clear & not brown IF available) – 20 – 25 drops (Iodine breaks down METAL, so don’t put it in your blender or beat with a metal whisk ~ Iodine also helps to rid the system of any radiation poisoning).

1. If you have Colloidal Copper or Silver, you can add a little.
2. You can add about 5 – 8 drops of any Essential Oil (NOT Tea Tree Oil!) to scent your mix. eg. Lemon Grass

METHOD for application:
1. Pour a little at a time into the palm of your hand and lightly rub / blend all over your skin ~ but NOT the genitals where it may sting.
2. After sometime ??? – you will probably or more than likely notice tiny ‘fibres’ surfacing. THESE ARE STILL TOXIC & dangerous, so it would be best to take a special Morgellons BATH afterwards, to wash these toxic fibres off.

1. Use Betadine SOAP.
2. Add 1/4 Cup if each added to your bath water ~ BICARB OF SODA; TSP (Trisodium phosphate); Epsom Salts OR if available, but not necessary, you can possibly add 1 ounce of “Miracle” Salt in place of Epsom Salts.
3. Add 1 CAP of Betadine solution.
5. Fill the bath as high as possible and sit in it for at least 20 minutes, then use a nice soft body-scrub brush & start brushing!!!
6. Once toweled down (put that towel in the wash away from other laundry items) and RE-APPLY the above SOLUTION / MIXTURE to whichever parts of your face and/or body that will be exposed to the outdoor elements.

1. Absolutely AVOID any / ALL GMOs (Genetically Modified products)!!!
2. When CHEMTRAILS are obvious in your sky, avoid skin exposure whilst outdoors.
3. If you ever see ‘web-like’ things outdoors, NEVER ever touch them!!!
4. After applying the Stripper Solution, once it dries on the skin, it leaves a slight sheen BARRIER (protection for further contamination), and when coming into contact with Chemtrail poisons, you MAY sometimes even feel as though you have walked through a spiders web. That’s because the solution is reacting with whatever toxins are in the atmosphere.


Eczema in Infants Linked to Gut Bacteria

Jan. 21, 2013 — Children with eczema have a more diverse set of bacteria in their guts than non affected children, finds a new study in BioMed Central’s open access journal BMC Microbiology. The types of bacteria present were also more typical of adult gut microbes than for toddlers without eczema[U1] .—Eczema is a chronic inflammation of the epidermis. The gut bacteria of children with or without eczema was examined when they were six and 18 months old. At six months all the infants had the same types of bacteria but by 18 months old the children with eczema had more of a type of bacteria normally associated with adults (Clostridium clusters IV and XIVa) while the healthy children had a greater amount of Bacteroidetes.—MSc Lotta Nylund from University of Turku, Finland, who led the project explained, “The composition of bacteria in a child’s gut depends on its environment and the food it eats. You would expect that as a child’s diet changes so will the bacteria present. The number of bifidobacteria naturally falls with age and in total we found 21 groups of bacteria which changed in this time period. However it is the early change towards adult-type bacteria which seems to be a risk factor for eczema.”—Journal Reference-Lotta Nylund, Reetta Satokari, Janne Nikkilä, Mirjana Rajilic-Stojanovic, Marko Kalliomäki, Erika Isolauri, Seppo Salminen and Willem M de Vos (in press). Microarray analysis reveals marked intestinal microbiota aberrancy in infants having eczema compared to healthy children in at-risk for atopic disease. BMC Microbiology, 2013 [link]

Special Note On Healthy Bacteria–To mimize this while breast feeding consume a good priobiotic enriched yogurt or dairy or a kefir and while gestating the child consume it orally as well—other studies have validated that the increased levels of yogurt during this time will increase the protection for respiratory ad digestive system


Caloric Restriction Has a Protective Effect On Chromosomes

A sustained lowering of food intake over time results in an increase of telomere length — the ends of chromosomes — Jan. 23, 2013 — One of the indicators of a cell’s health is the state of its DNA and containers — the chromosomes — so when these fuse together or suffer anomalies, they can become the source of illnesses like cancer and/or aging processes.–According to a study carried out by a team led by María Blasco, the director of the Spanish National Cancer Research Centre (CNIO) and head of the Telomeres and Telomerase Group, a sustained lowering of food intake over time results in an increase of telomere length — the ends of chromosomes — in adult mice, which has a protective effect on the DNA and genetic material.—These beneficial effects on the youth of the chromosomes translate to a lower incidence of cancer and other age-related illnesses. The journal PLOS ONE is to publish the details of this study in its online edition this week.

A lower incidence of cancer and better health—To carry out the study, researchers used young mice — just three months old — and reduced their caloric intake by 40[U2] % before observing them until the end of their life cycle.-“We see that mice that undergo caloric restriction show a lower telomere shortening rate than those fed with a normal diet,” says Blasco. “These mice therefore have longer telomeres as adults, as well as lower rates of chromosome anomalies,” she adds.—To study the effects of this phenomenon on the health of the mammals, researchers observed the incidence of age-related illnesses like cancer. The mice that had been fed a lower calorie intake showed a reduction in the incidence of cancer. Furthermore, these mice also showed a lower incidence of other age-related illnesses such as osteoporosis, greater glucose uptake or improvements in motor coordination.—When the researchers carried out these same experiments with a variety of mice that produce more telomerase — a protein that lengthens telomeres and protects chromosomes — they observed that these mice not only enjoyed better health but also lived up to 20% longer.—“We believe that such a significant increase in longevity is due to the protective effect against cancer produced by caloric restriction — incidents fall by 40% if we compare them with the mice that produce more telomerase and have a normal diet — and, added to the presence of longer telomeres, this makes the mice live longer and better,” says Blasco.—Despite the effects of caloric restriction depending on the genetic characteristics of each organism, this study opens the way to studying the effect other factors and lifestyle habits, such as smoking or exercise, might have on aging.—Furthermore, it is calculated that there are currently more than 10,000 people in the world on some form of controlled caloric restriction, so the observation of these individuals will be decisive in discovering the effects of this type of diet on humans.—=Story Source-The above story is reprinted from materials provided by Centro Nacional de Investigaciones Oncologicas (CNIO), via EurekAlert!, a service of AAAS. –Journal Reference-Elsa Vera, Bruno Bernardes de Jesus, Miguel Foronda, Juana M. Flores, Maria A. Blasco. Telomerase Reverse Transcriptase Synergizes with Calorie Restriction to Increase Health Span and Extend Mouse Longevity. PLoS ONE, 2013; 8 (1): e53760 DOI: 10.1371/journal.pone.0053760


Health Canada Approves Bio-K+® as a New and Effective Mean for the Reduction of Clostridium difficile Infections in Hospitals


MONTREAL, Jan. 16, 2013 /CNW Telbec/ – Today, Bio-K Plus International Inc., a leading Canadian biotechnology company, announced that Health Canada has approved its exclusive and patented Bio-K+® probiotic formula to help reduce the risk of Clostridium difficile (C. difficile) infections in hospitalized patients and those in long-term care facilities. Based on solid clinical evidence published in prestigious medical journals, including the American Journal of Gastroenterology, this approval is confirmation that Bio-K+® is a proven safe and effective product. Despite all preventive measures used, C. difficile still remains a high cause of hospital acquired infections (HAIs) responsible for over 1,000 Canadian deaths yearly unrelated to the cause of hospitalization. Health professionals can benefit from this effective product to protect their patients and help fight C. difficile infection at a very low cost compared to C. difficile treatment. —“Although the company continues its R&D program, the clinical results published to date, on this unique product, have demonstrated its potential of reducing the risk of this prevalent disease. Health Canada’s approval is further support for the product’s role in prevention of C. difficile associated diarrhea,” said Dr. Donald Low, Microbiologist-in-Chief at Mount Sinai Hospital in Toronto.

Making Our Healthcare System Safer—A Canadian hospital study found that of 136,877 hospital admissions, 1 in 100 patients will contract a C. difficile infection, and of those, 1 in 10 will die regardless of the initial reasons for admission. “Bio-K+® is an innovative product that works to reduce the risk of hospital acquired or antibiotic-associated C. difficile infections. Health Canada’s approval of Bio-K+® represents a milestone in further recognizing the importance of such products in the prevention landscape,” said Dr. Ian Bookman, Gastroenterologist at St. Joseph’s Health Center in Toronto. —In Quebec, there were 3,934 C. difficile infections resulting in 619 deaths (i.e. 16% of infected patients) between 2010 – 2011. Since 2004, the Pierre-Le-Gardeur Hospital in Montreal, reacting to a major outbreak, has used Bio-K+® on its formulary and also provides the product to all patients treated with antibiotics with no exclusion factors, as a risk reduction measure to control C. difficile. -“Our hospital has almost 9 years of pharmaco-vigilance with more than 40,000 patients using Bio-K+® products with no serious adverse events reported and we have maintained one of the lowest rates of C. difficile in the Province of Quebec,” said Dr. Pierre-Jean Maziade, Microbiologist and Head Officer of Infection Preventions at Pierre-Le-Gardeur Hospital, Montreal.

About Bio-K Plus International Inc.
Bio-K Plus International Inc. is a Canadian biotechnology company, committed to medical research and to develop breakthrough innovative products capable of improving human health and quality of life. The company has over 100 employees in Canada and the United States. Bio-K+® is a quality probiotic product that is distinguished by its exclusive and patented formula. It is available in fermented drinks or enteric-coated capsules, dispensed in hospitals, pharmacies, health food stores and supermarkets in North America. The company is also GMP certified by NSF International. This certification confirms the commitment of the company to provide high quality products of international standards. —SOURCE: Bio-K+ International Inc.

For further information:
Dr. Serge Carrière
Managing Director, Scientific Affairs
Bio-K Plus International Inc.

Isabèle Chevalier
Bio-K Plus International Inc.

Media Contact:
Elizabeth Tanguay
Cohn & Wolfe | Montréal
Direct line: 514 845-7064 |cellphone: 514-627-6919



[U1]This would imply strongly a contaminant that the child has gotten exposed to as the adult—a carcinogen—a food contaminant or even a food genetically disorienting the colon

[U2]So if you were to explore this take your full caloric intake –example 2000cal a day take 40% that would keave you 1200—so the idea is to keep using that number daily—would see a increase in metabolism—less pollutant build up of foods and chemicals or genetics on the foods—less wear and tear on pancreas and stomach and liver