Antidepressant Prozac—Warnings

There have been 27 drug regulatory agency warnings from six countries (United States, New Zealand, United Kingdom, Ireland, Australia and Canada) and the European Union on Prozac. These are as follows:

United States, December 14, 2011: The FDA notified healthcare professionals and the public about the use of selective serotonin reuptake inhibitor (SSRI) antidepressants, including Prozac, 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, July 26, 2011: The FDA issued a warning about serious central nervous system (CNS) reactions that occur when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (such a Prozac). Some of the reactions included Serotonin Syndrome (a potentially life threatening drug reaction that causes the body to have too much serotonin), trouble with coordination, muscle twitching, etc. There were also some deaths reported. Source: Zyvox (linexolid), MedWatch Safety Information, July 26, 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. 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 (flluoxetine hydrochloride), Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)” FDA, April 2011,

New Zealand, September 2010: MedSafe issued in their Prescriber Update publication information 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 into an infants lungs after birth) and newborn withdrawal symptoms. Source: “The use of antidepressants in pregnancy,” Prescriber Update, MedSafe, Vol. 31, No. 3, September 2010.

United Kingdom, March 01, 2010: The Medicines and Healthcare products Regulatory Agency (MHRA) published a warning about the 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 01, 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’s (EMA) analysis of the subject. The EMA 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 Newsletter, Irish Medicines Board, Iss. 36, March 2010.

United States, March 01, 2008: The FDA added the following information to Prozac’s safety label: Abnormal Bleeding, Hyponatremia (not enough sodium in the body fluids outside the cells), may result; certain drug interactions with drugs such as, NSAIDs (non-steroid anti-inflammatory drugs), aspirin, and warfarin (an anticoagulant), and precautions with geriatric use. Source: “Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2008,” FDA, March 2008.

United Kingdom, February 05, 2008: UK’s Medicines and Healthcare products Regulatory Agency ordered drug companies to update the warnings on antidepressants, such as Prozac, to show that they cause suicidal thoughts and behavior. Source: “Implementation of warnings on suicidal thought and behaviour in antidepressants,” Medicines and Healthcare Products Regulatory Agency, February 5, 2008.

European Union, January 2008: The Pharmacovigilance Working Party (a party that provides advice on the safety of medicinal products and on the investigation of adverse reactions associated with medicinal products authorized in the European Union) recommended an update to product labeling and all antidepressants (including Prozac) patient information leaflets to include information on the increased risk of suicide for children to young adults. Source: “Antidepressants and suicidal thoughts and behaviour,” Pharmacovigilance Working Party, January 2006.

United States, May 02, 2007: The FDA officially extended the age group covered in the October 15, 2004 black box warning regarding antidepressants (including Prozac) causing suicidal tendencies in children and adolescents, to include 18 to 24 year-olds. Source: “FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications,” FDA News, May 2, 2007.

United States, July 19, 2006: The FDA issued a Public Health Advisory regarding the combination of certain migraine medications and certain types of antidepressants. The combination of these drugs can cause a life-threatening condition called serotonin syndrome (which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea). The migraine medications (Amerge, Axert, Frova, Imitrex, Maxalt, Maxalt-MLT, Relpax, Zomig, Zomig-ZMT) should not be combined with any of these newer antidepressants: Celexa, Luvox, Lexapro, Paxil, Prozac, Symbyax, Zoloft, Cymbalta, Effexor. Source: “Public Health Advisory – Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May Result in Life-threatening Serotonin Syndrome,” FDA, July 19, 2006.

United States, July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took newer antidepressants, such as Prozac, during pregnancy. The agency added that 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 this potential risk on their drug labels. Source: Susan Heavey, “U.S. FDA warns of new antidepressant risks,” Reuters, July 19, 2006.

Australia, June 05, 2006: The Australian Therapeutic Goods Administration drug adverse reaction database showed there had been 827 adverse reactions reported in 380 separate cases for antidepressant use (including Prozac) among under 10-year-olds. Apart from deaths, these included convulsions, self-harm, muscle spasms, tremors, hallucinations, deafness, paralysis and Tourette’s syndrome. A further 833 adverse health responses, in 385 cases, had been linked to use by youths aged between 10 and 19 years. The reactions included 3 deaths. Source: “Drugs driving kids to suicide,” Daily Telegraph, June 5, 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 (including Prozac) 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.

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 (which includes Prozac) 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.

United States, June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications,” which stated that several recent scientific publications suggested the possibility of an increased risk of suicidal behavior in adults taking both older and newer antidepressants (which includes Prozac). It recommended that physicians monitor adults who took antidepressants for suicidal tendencies. Source: “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, June 30, 2004.

European Union, April 25, 2005: The European Medicines Agency’s Committee for Medicinal Products for Human Use concluded that antidepressants (like Prozac) 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 States, October 15, 2004: The FDA ordered pharmaceutical companies to add a “black box” warning to antidepressant packaging (including Prozac), explaining that the drugs could cause suicidal thoughts and actions in children and teenagers. It also directed the manufacturers to print and distribute medication guides with every antidepressant prescription and to inform patients of the risks. Source: “Suicidality in Children and Adolescents Being Treated With Antidepressant Medications,” FDA Public Health Advisory, October 15, 2004.

Canada, June 03, 2004: Health Canada issued an advisory to the public that stated 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.” The drugs mentioned in this Advisory are Wellbutrin (bupropion), Zyban (bupropion), Celexa (citalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Paxil (Paroxetine), Zoloft (sertraline), Effexor (venlafaxine). Source: Jirina Vlk, “Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants,” Health Canada, 2004-31, June 3, 2004.

United States, March 22, 2004: The FDA asked drug companies to add new warnings on 10 widely used antidepressants. It said patients who used Prozac (fluoxetine), Zoloft (sertraline), Paxil (Paroxetine), Luvox (fluvoxamine), Celexa (citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone), and Remeron (mirtazapine), should be closely monitored for possible suicidal behavior and anxiety, especially when the patient first begins taking the drugs or changes doses. It stated, “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.” Source: “Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medications,” FDA Public Health Advisory, March 22, 2004.

Canada, February 03, 2004: Health Canada issued a warning to the public about Prozac, Paxil, Celexa, Luvox, Remeron, Zoloft and Effexor. The warning states that reports show an increased risk of suicide in children taking these drugs. Health Canada said its action was based on international studies that linked the use of these drugs to “suicide-related events,” suicides and suicide attempts. Source: “Health Canada advises Canadians under the age of 18 to consult physicians if they are being treated with newer anti-depressants,” Health Canada, February 2004.

United States, October 27, 2003: The FDA released a “Health Advisory” where they announced that they had completed a preliminary review of reports of suicidality in pediatric patients for eight antidepressant drugs (both newer and older antidepressants, including Prozac) and had determined that additional data and analysis and public discussion of available data were needed on the issue. The Health Advisory simply urged health care professionals to use the drugs with caution. Source: Food and Drug Administration (FDA), “Reports of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD),” October 27, 2003.

Australia, August 01, 2003: The Australian Therapeutic Goods Administration reported that the use of newer antidepressants, like Prozac, during or after pregnancy may result in adverse reactions to newborn babies, due to the withdrawal effect following intra-uterine exposure, or a toxic effect from ingestion of an antidepressant in breast-milk. The withdrawal effects the baby experienced included agitation, jitteriness, poor feeding, sleepiness/lethargy, gastrointestinal symptoms and hypotania (deficient tone or tension). Source: “Maternal SSRI Use and Neonatal Effects,” The Australian Therapeutic Goods Administration, Adverse Drug Reactions Bulletin, Vol. 22, No. August 4, 2003, p. 14.

Australia, February 01, 2000: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting that newer antidepressants are commonly reported to cause nightmares and specifically mentioned Prozac, Zoloft, Paxil and Celexa. Source: “Drug-induced nightmares,” Australian Therapeutic Goods Administration, Adverse Drug Reactions Bulletin, Vol. 19, No. 1, February 2000.

Australia, November 01, 1997: The Australian Therapeutic Goods Administration reported that there has been an increasing number of reports to the adverse drug reactions advisory committee on the effects of newer antidepressants (such as Prozac) on newborns. Some of the reports described withdrawal reactions in newborns whose mothers had taken newer antidepressants throughout their pregnancies; reports relate to probable breast milk transfer. Practitioners should consider this possibility when prescribing to depressed patients who are pregnant or breastfeeding. Source: Therapeutic Goods Administration, “SSRIs and neonatal disorders,” Australian Adverse Drug Reactions Bulletin, Volume 16, Number 4, November 1997.

United Kingdom, May 01, 1989: The Medicines and Healthcare products Regulatory Agency published warnings in their Current Problems bulletin, about fluvoxamine and fluoxetine (Prozac) interactions with older antidepressants, lithium, and tryptophan. The combinations can increase the risk of severe side effects such as serotonin syndrome, tremor and convulsions. Source: “Serious interaction between tamoxifen and warfarin,” Current Problems, MHRA, No. 26, May 1989.


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