Prozac (fluoxetine) is the most popular selective serotonin reuptake inhibitor (SSRI) in history. The antidepressant’s side effects include birth defects and suicidal thoughts and actions. As of February 2018, the FDA had not warned of new side effects. But, a January 2018 article found the drug may affect attention span in children.
Prozac (fluoxetine) is an antidepressant. It was the first drug in the selective serotonin reuptake inhibitor (SSRI) class. Eli Lilly manufactures Prozac.
The U.S. Food and Drug Administration approved the drug in 1987. The FDA approved it to treat depression in adults, children and adolescents.
People received 24.4 million prescriptions for generic fluoxetine in 2010. It is the third most prescribed antidepressant in the U.S.
Prozac earned the nickname “bottled sunshine.”
The drug also comes with some serious side effects. These include sexual dysfunction, suicidal thoughts and anorexia.
Studies link it to birth defects and side effects in children.
In January 2018, study author Edward Hackett said that healthy children who take Prozac may experience attention problems.
Hackett and colleagues published their data in Developmental Cognitive Neuroscience in August 2017. They found Prozac had negative effects on attention span, impulsive behaviors and sleep in young monkeys.
As of February 2018, the FDA had not added new warnings to Prozac’s label.
The FDA approved Prozac to treat four psychiatric disorders and an additional two in combination with Symbyax (olanzapine). In addition to the FDA-approved uses, doctors may also prescribe the drug off-label — for uses not approved by the FDA.
Generally, off-label uses may be helpful to patients who have no other treatment for an illness or condition. But these uses may not have clinical trials that prove safety or effectiveness
Prozac comes in a number of strengths and dosage indications. The typical dose is 20 mg a day taken in the morning. But depending on the psychiatric disorder treated, the frequency and dose may vary. The time of the day is also important in Prozac dosing. Some indications call for patients to take Prozac and Symbyax together.
Even after three decades, researchers continue to study Prozac’s effects on the body, and new information about potential complications is still coming to light. The safety insert lists a number of side effects discovered during clinical trials. In addition to common and mild side effects, Prozac may cause serious adverse events — some fatal.
Although most doctors don’t consider Prozac addictive — at least in the sense of inducing cravings in patients — doctors say it can make patients dependent. Drug dependency means that the body has adapted to a chemical to the point that it requires steady doses to normally function.
Because of this, patients who abruptly stop taking antidepressant drugs such as Prozac are likely to experience withdrawal symptoms such as nausea, headache, dizziness and lethargy. Patients must wean themselves off antidepressants slowly and under a doctor’s care.
High doses of SSRIs often increase the severity of side effects, and one particular side effect—Serotonin syndrome — can be fatal. Serotonin syndrome is a condition in which the body produces too much serotonin — a neurotransmitter that controls mood and behavior.
Symptoms can occur within minutes and include high blood pressure, hyperthermia, high body temperature and an increased heart rate that can lead to shock. Serotonin syndrome can arise when SSRIs act alone or in conjunction with other medications.
Prozac is one of the few antidepressants approved for the treatment of depression in youths. Unfortunately, however, studies on children have linked the drug to increased suicidal thoughts and behavior.
As a result, the FDA issued a public warning in October 2004, and two years later extended the advisory to include young adults as old as 24.
In 2007, the FDA took an even stronger stance. The agency required antidepressant manufacturers to update existing black box warnings about the increased risks of suicidal thoughts and behavior during initial treatment in the first one to two months.
An FDA black box warning is the most stringent precaution a drug can carry before it is pulled from the shelves. It takes its name from the black border that surrounds the warning information on the drug’s packaging. The agency often requires pharmaceutical companies to include a bold warning on drug packaging and patient instruction sheets if serious or life-threatening risks are associated with the drug’s use.
In studies, most SSRIs can harm unborn animals in large doses, but there are no adequate studies in pregnant women. According to the Prozac medication insert, pregnant women should only use Prozac if the benefit outweighs the risk to the fetus, and breast feeding is not recommended.
The FDA released a Safety Announcement in 2006 warning that SSRIs including Prozac can increase the risk of rare heart and lung condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during the last half of pregnancy. The agency stated in its communication, “FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.”
“FDA Will update the SSRI Drug Labels to reflect the new data and the conflicting results.”
This condition arises when a newborn’s circulatory system does not properly adapt to breathing outside of the womb. The FDA based the initial warning on one study. Then, the agency found more studies with conflicting findings and released another warning in 2011.
So far, the FDA has yet to make a final ruling.
A study published in the British Medical Journal (BMJ) in July 2015 by Jennita Reefhuis and colleagues linked Prozac to increased risk of heart wall defects, craniosynoctosis and heart defects.
Researchers from the CDC’s National Center on Birth Defects and Developmental Disabilities studied about 28,000 mothers with children born between 1997 and 2009. Of the 9,857 mothers of babies with birth defects, 659 reported taking an SSRI during pregnancy.
Prozac may interact with a variety of drugs and some complications may be severe. Side effects of drugs interaction include internal bleeding, seizures and abnormal heartbeats. Patients should always check with their doctor before taking any medication with Prozac.
Critics of the drug say there is no real proof the drug works. One of these critics is Dr. Alexander Bingham. He is a psychotherapist who spent years studying Prozac.
“Eli Lilly, the manufacturer of Prozac, conducted 20 clinical trials, 17 of which were so bad and so flawed . . . that they didn’t even submit them,” Bingham told Drugwatch. “They only submitted three to the FDA and were denied approval twice.”
Prozac has a controversial history filled with early failures.
Chemists Klaus Schmiegel and Bryan Molloy discovered the drug in 1971. The drug failed to treat blood pressure and obesity.
Then, the company tested the drug on hospitalized depressive patients. Not only did the drug not work, it made some patients worse.
The drug finally worked when Lilly tested it on five mildly depressed patients and all five improved.
Please seek the advice of a medical professional before making health care decisions.
Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.
Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.(888) 645-1617