Prozac® is an antidepressant medication generally prescribed to treat major depression, anxiety disorders, and even autism in adults. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Eli Lilly and was the first SSRI to be approved for use in the United States. The generic version, fluoxetine, is also available by prescription.
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Questions & Answers
I was prescribed Prozac for depression, and I didn’t notice an improvement in my depression.
Side Effects & Adverse Reactions
As with all antidepressants, Prozac carries the FDA’s black box warning due to an increased risk of suicidal thoughts/ideation and actions, especially in children and young adults. (.pdf)
Common side effects include fatigue, insomnia, nausea, dry mouth, headache, diarrhea, dizziness, weight gain, and sexual dysfunction (difficulty achieving arousal, erection and/or orgasm).
Prozac is officially classified by the FDA as Category C, meaning that risk cannot be ruled out. Babies born to women taking Prozac during pregnancy have often shown to suffer similar withdrawal symptoms as adults as the drug leaves their body after birth, as well as requiring extra neonatal hospital care including respiratory support and tubal feeding. Infants exposed to SSRIs during pregnancy may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN), also known as persistent fetal circulation, which is where the circulation in a newborn reverts back to the way it worked in utero, mostly bypassing the lungs. (.pdf)
Like many other antidepressant medications, the discontinuation of regular use of Prozac can cause numerous unpleasant withdrawal side effects, including flu-like symptoms (nausea, vomiting, sweating, headaches, diarrhea), sleep disturbances (insomnia, nightmares, fatigue), sensory/movement disturbances (vertigo, dizziness, “zap” like electrical sensations in the brain or nerve paths), and mood disturbances (anxiety, dysphoria, agitation). Most cases of these withdrawal symptoms are mild and resolve themselves after 1-4 weeks. (ncbi.nlm.nih.gov)
Possible Adverse Interactions (Contraindications)
Prozac should not be taken with, or immediately after stopping use of, monoamine oxidase inhibitors (MAOIs), another class of commonly used antidepressants, as well as the antipsychotic drug Thioridazine, as this can cause serotonin syndrome or serotonin toxicity, a condition that can be fatal. Prozac is also contraindicated for use with the antipsychotic medication pimozide (Orap) due to the risk of serious heart problems. (.pdf)
In the nearly 3 decades that Prozac has been available to the public, hundreds, if not thousands, of lawsuits have been filed against Eli Lilly alleging mental and physical side effects stemming from use of the drug. While they have never actually lost any of these cases, Lilly is reported to have paid in the tens of millions of dollars in settlements for cases related to suicides and murders, mostly undisclosed. Many of these cases predated the advent of the popular use of the internet, so information is scattered.
Some notable cases include:
- A lawsuit filed by the families of the victims of Joseph Wesbecker, who shot and killed 8 and injured 12 of his former coworkers at his former workplace, less than a month after starting Prozac. Lilly won this case initially, until a judge determined that the plaintiffs had been paid to withhold damaging evidence. (breggin.com), (cnn.com)
- A lawsuit filed by the husband of LaVerne Shell, who killed herself 11 days after starting Prozac.
- A lawsuit filed by Diane Cassidy, who survived a suicide attempt after being prescribed Prozac off-label for weight loss. This suit, as well as the Shell suit, was notable for its argument of the concept of “poor metabolizers” – people whose bodies lack the proper enzyme to break the drug down sufficiently, and therefore build up much higher amounts in their system than intended. Both cases settled out of court under undisclosed terms. (freerepublic.com)
In 1999, a settlement was reached in a patent infringement lawsuit filed by Lilly against three other pharmaceutical companies hoping to manufacture generic versions of Prozac. (nytimes.com)
FDA Safety Alerts
December 14, 2011
A general alert communication was sent out by the FDA regarding SSRI use and the risk of PPHN (persistent pulmonary hypotension in the newborn). (fda.gov)
A communication was sent out by the FDA to healthcare professionals regarding the risks of PPHN and serotonin syndrome when using SSRIs. (fda.gov)
Two letters were sent to healthcare providers from British pharmaceutical manufacturer GlaxoSmithKline mentioning Prozac as part of a group of drugs that would now receive the FDA black box warning regarding the risk of suicidal thoughts or behavior. (.pdf), (.pdf)
FDA Labeling Changes
Additions were made to the Warnings and Precautions section of the label, indicating that post-marketing observations of heart arrhythmia symptoms were seen in patients treated with fluoxetine. (fda.gov)
Labeling changes were made to the Contraindications (interactions with MAOI antidepressants), Warnings and Precautions (Serotonin Syndrome), Use in Specific Populations (PPHN), and Medication Guide (MAOIs). (fda.gov)
Updated information was added to the Warnings section (cautions regarding patients with Acute Narrow-Angle Glaucoma) and Adverse Reactions section (patients reporting persistence of sexual dysfunction after discontinuing use of Prozac, as well as memory impairment). (fda.gov)
Additions were made to the Adverse Reactions section of the label, adding a handful of conditions including hypotension (low blood pressure), bruxism (teeth grinding), alopecia (hair loss), etc. There were also additions made to the Use in Specific Populations section regarding possible cardiovascular defects in babies born to women who used Prozac/fluoxetine in the first trimester. (fda.gov)
Modifications were made to the medication guide section of the label. (fda.gov)
Three warnings (one for each method of delivery available) were issued regarding the potential for the potentially fatal complication serotonin syndrome, also known as serotonin storm or serotonin toxicity, or a similar condition called neuroleptic malignant syndrome. Both of these conditions can occur when Prozac is taken in combination with MAOIs, or other drugs that alter the neurotransmission of serotonin. (fda.gov), (fda.gov), (fda.gov)
Precautions were added to the label making changes to the following subjects: abnormal bleeding as a potential side effect, and interactions with drugs that interfere with the clotting and flow of blood (Non-selective NSAIDs, aspirin, warfarin, etc.). (fda.gov)
Prozac is used in the treatment of major depressive disorder, anxiety and panic disorders including social anxiety disorder (also known as social phobia), post-traumatic stress disorder, premenstrual dysphoric disorder, eating disorders (bulimia nervosa and binge eating disorder) and less commonly used in the treatment of cataplexy, alcohol dependence, and obesity. It has also been implemented in treatment of autism spectrum disorders in adults, with moderate success.
Prozac was the first ever SSRI, with a long and colorful history beginning in the early 1970’s. Scientists at Eli Lilly began to experiment with and synthesize new compounds using as a model the common antihistamine diphenhydramine (better known in US markets by its brand name, Benadryl), which was already known to have mild antidepressant-like qualities. Of these synthesized derivatives, the compound that would eventually be dubbed fluoxetine (in 1975) showed the most potent and selective inhibition of serotonin reuptake. It would be approved by the FDA in December of 1987.
Fluoxetine was originally intended as a medication to treat hypertension (high blood pressure), with which it seemed to have had success in animal testing trials, and obesity, but experienced unsuccessful human clinical trials for both purposes. It was noticed to have mood lifting effects in some trial patients, however, and a new antidepressant was born.
The introduction of Prozac to the market sparked a cultural phenomenon. It was hailed by some as a “wonder drug.” It was touted to relieve a wide range of conditions with little to none of the side effects that came along with its predecessors (tricyclic antidepressants, benzodiazepines, barbiturates). It was not sedating or intoxicating, making it easier to tolerate with everyday activities. Prozac even has its own entry in most English dictionaries, has been referred to as “bottled sunshine,” and has had books and films made detailing users’ experiences with the drug (Elizabeth Wurtzel’s Prozac Nation, Lauren Slater’s Prozac Diary). There are many testimonials indicating that Prozac has saved users’ lives or marriages. It has been used by millions of people, and has netted billions in revenue for Eli Lilly.
In contrast with its initial appeal, however, Prozac has also developed a dark reputation, and in turn has earned criticism just as widespread as its praises. Shortly after its introduction, accounts began pouring in regarding negative mental side effects such as disturbing thoughts, hostility, violent compulsions, and suicidal ideation and behavior, and those accounts do not appear to have ceased since. The use of, or discontinuation of, Prozac and similar drugs in its class have been associated with some of the biggest headlining violent crimes since its introduction, notably school/mass killings. Hundreds of lawsuits have been filed, and support groups for “survivors” of Prozac have been formed. As early as 1991, the FDA has heard the testimony of hundreds of people who represent the loved ones of those injured or killed while using Prozac or by someone else using Prozac. While much of this is often dismissed by the idea that it is the illness of depression that drives violent actions and/or suicide, the sheer number of these cases eventually drove the FDA to issue the standard black box warning that appears at the top of the labels for all antidepressants in 2004.
The patent for Prozac expired in 2001, allowing for the production of generic fluoxetine. Despite the variety of similar drugs available, it still remains very popular, with over 20 million prescriptions filled in the US in 2011. (psychcentral.com)
Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79. The structural formula is:
Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water.
Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10– and 20–mg Pulvules also contain FDandC Blue No. 1, and the 40–mg Pulvule also contains FDnadC Blue No. 1 and FDandC Yellow No. 6.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.
Prozac Weekly™ capsules, a delayed–release formulation, contain enteric–coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 μmol) of fluoxetine. The capsules also contain DandC Yellow No. 10, FDandC Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients.