By Judy Hittman and Diana Zuckerman, PhD
Updated February 2015
For patients who suffer from depression or anxiety, it’s hard to know which medication is best. It seems everyday a new “wonder drug” is introduced, often costing 10 or 20 times as much as older medications. Things become even more confusing when doctors prescribe medications “off label,” which means that the FDA has approved the drug as safe and effective for a specific use, but the doctor is prescribing it for another use which is not FDA approved.
A group of popular and widely advertised drugs that were approved by the FDA to treat psychotic conditions such as schizophrenia and psychosis (such as hallucinations) that are sometimes associated with bipolar disorder (manic depression), are bringing in billions of dollars in sales. Although the evidence is questionable, some of these drugs are also approved by the FDA to use with antidepressants if the antidepressants are not effective by themselves. Most prescriptions for the drug are “off label”– for anxiety, insomnia, PTSD, and even for ADHD and behavior problems in children and the elderly. Despite their huge sales, Seroquel, Abilify, Zyprexa, Risperdal, Geodon and similar drugs often causes rapid weight gain, breast development in boys and men, and may also have serious adverse effects such as diabetes, hyperglycemia, pancreatitis, and sudden death.
When the FDA approves a drug with such serious side effects, they look at the balance of risks and benefits. Such serious risks may be considered acceptable for schizophrenia treatment or for severely depressed individuals, but should not be considered acceptable when the benefits are not proven or when safer treatments are available.
Little Benefit for Depression
Even for the approved use of hard-to-treat depression, the benefits of these drugs are minimal. In fact, the patients on placebo (“sugar pills” that look just like medication) are improving greatly in these studies – almost as much as those taking Seroquel. Most of the improvement for patients is apparently due to the placebo effect: when depressed or anxious patients take a new pill, they tend to get better, even if the pill has no active ingredients that work. The drug itself appears to add little benefit. The difference between depression scores for patients taking Seroquel or some of these other drugs is just slightly better than the scores for the patients taking the placebo. These differences are sometimes statistically significant, but that doesn’t mean they are meaningful improvements to the patients. In fact, these antipsychotic drugs don’t contain any ingredients that are targeted to reduce depression or anxiety. Instead, patients taking these drugs tend to feel “knocked out” – they tend to fall asleep. That may improve their scores on an anxiety scale or depression scale (since anxious and depressed people often have trouble sleeping) but it doesn’t mean the patient actually feels less anxious or depressed.
The bad news is that in addition to those modest benefits there are many serious risks. Patients taking these drugs are significantly more likely to drop out of the study because of side effects (such as drowsiness or weight gain) than the placebo patients. Since the studies that companies conducted are short-term (only 6-8 weeks), they don’t measure long-term adverse effects. These short-term studies are inadequate because patients with depression, PTSD, and these other problems have those conditions for many years. For example, in 2015 a 20-year old boy was awarded $2.5 million because he developed large breasts from taking Risperdal. Johnson & Johnson, the company that makes Risperdal, does not deny that the drug caused the side effect but claims that the benefits of the drug still outweighed this complication. Unfortunately, when boys develop breasts as a result of Risperdal, stopping the medication does not solve the problem. Surgery is needed to remove the breasts.
In addition to diabetes and the above-mentioned risks, patients are at risk of developing tardive dyskinesia, a condition that causes uncontrolled movements, such as grimacing, tongue protrusion, and lip smacking. There is a lack of effective treatments for these symptoms and stopping the drug after the problems have started usually doesn’t work. The nonprofit organization that educates people about movement disorders such as tardive dyskinesia, is clear about the importance of avoiding drugs that can cause this disorder; they say: “every effort should be made to limit the use of these drugs to those patients for whom no other treatment options are available.” Drugs that can cause tardive dyskinesia should therefore never be given to anyone with depression or anxiety unless every other, safer drug has already been tried and failed.
Consumers need to be their own advocates because even if a prescription drug label warns to try other medications first, many doctors tend to overlook that warning, especially when drug companies spend billions of dollars for advertisements, speeches, medical articles, and personal meetings to “educate” doctors about how effective the drug is.
The most alarming reason to avoid these drugs is the danger of sudden death. Although relatively rare, this risk is unacceptable for any treatment where the benefits are unproven or very modest.
At the FDA’s April 2009 public meeting on Seroquel, family members testified about how their loved ones, veterans of the Iraq war, had died after being prescribed Seroquel from the VA for post traumatic stress disorder (PTSD). Commented Harold S. White, who lost his son under questionable circumstances: “In my research, I have found at least 51 military men have died in their sleep in the past six years, 35 in the last three years.” He added that it “was always the same story,” with perfectly healthy people dying suddenly after taking the drug. Cassandra Harper testified that “the doctors and nurses (at Walter Reed) should be given more information on the drugs they prescribe and possible side effects/interactions.”
Choosing the Best Treatment
For example, rather than adding Seroquel or these other drugs when a patient’s antidepressant SSRI is not effective, consider cognitive behavioral therapy instead of pills or in addition to the SSRI if it is having a measurable benefit. Cognitive behavioral therapy is very safe and very effective, and unlike pills a relatively short treatment can have life-long benefits. It trains the patient to think about their shortcomings or problems in a different way, helping them to focus less on the helpless and hopeless feelings of depression and more on what they are doing well. If someone is suffering from insomnia, traditional sleeping pills are also dangerous , whereas the latest research suggests that warm milk or cognitive behavioral therapy are safe and also effective. If those don’t work, a sleep mask is worth a try.
We don’t know why so many doctors are prescribing drugs like Seroquel, which has dangers that don’t outweigh the risks except when used for schizophrenia and psychosis from bipolar disorder. We know that some physicians are influenced by the drug companies’ heavy advertising and promotional activities, which include paying famous and well-respected physicians to praise these drugs to other doctors. If you are not schizophrenic and don’t have psychosis from bipolar disorder (also called manic-depression), we suggest that you tell your doctor that you want a safer option.