The FDA Looks into Reports of Drug-Induced Depression
By Gerri Elder
The FDA has examined a link between some commonly prescribed medications and depression. Drugs that are often used to treat epilepsy, asthma, the flu and even depression as well as a drug used to help people overcome nicotine addiction have reportedly caused serious side effects, including depression and thoughts of suicide, in some patients.
While the FDA suspects an array of drugs could have the side effect of making patients depressed and self-destructive, it has not yet established a direct casual link between the use of the drugs and the dangerous side effects. However, in all cases, federal regulators have seen one of the two possible indicators of a problem.
In some scenarios, early clinical trials showed that patients who took the drugs had increased incidences of suicidal thoughts. The other indicator of the drugs potentially causing depression is evidenced by a surge of reports that patients treated for illnesses and disorders other than depression have developed symptoms of depression while taking the medications.
Examining the Data on Drugs Linked to Depression
Medical researchers have now begun the process of dissecting data to pinpoint evidence that the suspect drugs put patients at risk for dangerous psychiatric side effects. All future drugs will require the developers to look at these risks and take them into account when weighing the benefits of a drug against the dangers of unintended side effects.
Warnings from the FDA about Dangerous Drugs
The FDA first suggested that there could be a link between certain prescription drugs and the symptoms of depression about four years ago. Recent reports that adolescents who were treated with antidepressant medications were at more at risk of having suicidal thoughts and fantasies prompted an FDA warning in 2004. However, recent studies contradict the earlier findings and experts now feel that there may not be enough evidence to support the theory that antidepressant medications put already depressed teens more at risk for suicide.
In the future, the FDA hopes to detect the potential side effects of drugs and issue clear warnings to doctors and patients before they are widely prescribed.
More Rigorous Screening before FDA Approval
The Los Angeles Times reported that one of the first drugs to undergo more rigorous testing and screening for psychiatric side effects is the anti-obesity drug rimonabant. This drug is used in approximately 20 other countries, but has not gained yet gained FDA approval for the U.S. market. Early clinical trials showed that patients treated with rimonabant showed increased rates of anxiety and depression and therefore an FDA advisory panel voted last year to delay approval until more studies are done.
Drugs Suspected of Inducing Depression and Suicidal Thoughts
Tamiflu®: Last year in Japan, several teenagers died from apparent suicides while being treated for influenza with Tamiflu. One child experienced delirium, hallucinations and psychotic behavior while on the drug and ran out into traffic and was killed. The FDA advisory panel has been informed of 25 deaths and 365 cases of abnormal behavior in people under the age of 21 who took Tamiflu. The FDA notified Japanese physicians and urged them to closely monitor young patients with influenza, who might be taking an antiviral medication.
Relenza®: Relenza is a drug used to shorten the duration of influenza. It is similar to Tamiflu and manufactured by GlaxoSmithKline. Because Relenza and Tamiflu are popular drugs in Japan, GlaxoSmithKline voluntarily notified physicians that young patients treated with Relenza should be closely monitored for any unusual side effects.
Singulair®: The FDA announced on March 27, 2008 that it was investigating the possibility that the asthma and allergy medication Singulair is linked to changes in mood and behavior. The FDA's adverse-event monitoring system registered an increased number of reports about patients who took Singulair who developed symptoms of depression including suicidal thoughts.
Chantix®: Chantix is a drug that was developed to help smokers overcome nicotine addiction. It was approved by the FDA in May 2006. Many smokers who wished to kick the habit and were prescribed Chantix advised their doctors and the FDA that they had experienced abnormal behavior, agitation, depression, suicidal thoughts and self destructive actions that they could not explain. In January 2007, the FDA issued a warning and announced that "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."
Epilepsy Drugs: Last year the FDA noticed an increase in reports of suicidal behavior in people who take certain drugs for epilepsy. A broad review of the clinical trials of 11 anti-convulsive drugs was conducted, and on January 31, 2008, the FDA issued an alert to doctors notifying them that a link had been found between all 11 drugs used to treat patients with epilepsy and suicidal thoughts and actions. Patients treated with these drugs for as little as a week were twice as likely to develop suicidal thoughts and actions as those given a placebo.
Learn More about Possibly Defective Drugs
To get more information on possibly defective drugs, check out our defective drugs glossary. And if you have experienced unexpected side effects from a drug which caused you injury and are wondering whether you may have a personal injury claim, speak to a local personal injury attorney as soon as possible.