Does the FDA Take Suicide As Seriously as Other Side Effects?
Wednesday, February 13, 2008
Increasing reports of pharmaceutical-related suicidality have sparked a great deal of concern among patients and doctors. While the FDA has encouraged, and in some cases forced, drug companies to warn doctors and patients about the potential risk of suicidal behavior, critics argue that the warnings are insufficient and have come too late. They believe that the FDA acts more quickly and more aggressively when warning patients about other serious side effects than it does for suicidal and violent behavior.
SSRIs - Popular Depression and Mental Illness Drugs
No debate over the risk of suicidality has been greater than for SSRIs (Selective Serotonin Reuptake Inhibitors). These drugs, which are used to treat depression and other mental illnesses, have become some of the best selling drugs in the United States. They include Prozac, Paxil, Zoloft, Lexapro, Celexa, Remeron and Effexor. After hiding internal clinical data years, several drug companies finally released studies showing that these drugs do increase the risk of suicidality and violent behavior. While the risks were seen in all patients, they occurred most frequently in children 18 years of age and younger. In 2004, the FDA required the manufacturers of these drugs to add warnings about the risk of suicidality in patients 18 years of age and younger. In 2006, the agency strengthened the warning to include patients 24 years of age and younger.
When these studies were finally released, the drug companies reacted predictably, saying that the patients taking these medications are already depressed, and therefore more likely to commit suicide. The drug companies have a history of throwing patients and doctors under the proverbial bus when it benefits them. If a patient suffers adverse events from a medication, drug companies are very quick to point the finger at the doctor who prescribed the drug or the patient who took the drug. Meanwhile, the companies advertise directly to consumers on TV, radio, print and the internet and send pharmaceutical sales reps to doctors’ offices on a regular basis.
While SSRIs are approved by the FDA, pharmacologists and doctors are not quite certain how or why they work. New studies have also revealed that they are not as effective as drug companies have said. It is believed that certain brain chemicals called neurotransmitters are associated with depression, including the neurotransmitter serotonin. Some research suggests that abnormalities in neurotransmitter activity affect mood and behavior. SSRIs seem to relieve symptoms of depression by blocking the reabsorption, commonly referred to as reuptake, of serotonin by nerve cells in the brain. This leaves more serotonin in the nerve synapses, which should improve mood. While we believe that neurotransmitters in the brain affect mood, we don’t know exactly what else they affect; manipulating them may have unintended consequences, like suicidal or violent behavior.
FDA and Chantix
Perhaps acting proactively in light of the SSRI criticism, the FDA appears to have acted more quickly in warning about the potential risks of suicidal behavior in the smoking cessation drug Chantix. The agency said that some patients taking Chantix have attempted, and in some cases committed, suicide. The warning also said Chantix could be associated with violent and unusual behavior. Chantix, like the SSRIs, works on the brain’s neurotransmitters. This could explain why the drug appears to have similar side effects as antidepressants.
Pfizer, the manufacturer of Chantix, intially appeared reluctant to add the warnings to Chantix’s label, but has since done so under FDA pressure. However, the recent warnings haven’t stopped Pfizer from launching a large direct to consumer advertising campaign. In fact, the risk of suicidality and violent behavior is not mentioned in the television commercials for Chantix.
The Case for a Chantix Black Box Warning
Perhaps the recent Chantix warning indicates that the FDA is taking suicidal risks more seriously. But while the FDA required Pfizer to warn about suicidal risks on Chantix’s label, it did not require that warning to be a so-called “black box warning”, which is the strongest warning possible. The agency would most likely have required a “black box warning” on the drug if the side effects were liver damage or cardiovascular damage. The FDA’s quick action on Chantix is certainly welcomed, but the agency should treat mental side effects as seriously as liver failure, kidney failure or cardiovascular injuries. For this reason, we urge the FDA to require a “black box warning” on Chantix’s label about the risks of suicidal and violent behavior. We also strongly believe that the FDA should take the risk of suicidal ideation and suicidal behavior more seriously for all drugs. Consumers and healthcare professionals deserve to have the maximum amount of side effect information available when making decisions about which drugs to prescribe and take.
Posted under: Dangerous Drugs • Chantix