The FDA has called for warning labels on several drugs that have been linked with suicidal behavior.

FDA calls for new warning label on anti-depressant drugs

Mark York
Daily Sundial

In a new public statement, the Food and Drug Administration has called for new warning labels on the antidepressants Paxil and Zoloft, after concluding that these drugs increase the chance of suicidal thinking and behavior in some pediatric patients.

The drugs, used to treat anxiety and depressive disorders, have been the subject of increased scrutiny and lawsuits after several cases of suicide by teenagers and adults who take the drugs.

In the statement, the FDA Advisory Committee recommended that a “black box” warning label be added for a range of antidepressant drugs. According to the FDA, the vote was 15 to 8 in favor of the new label.

The FDA will take this into consideration and make a final ruling, but there is no indication as to when this will take effect. The label will be used for all of the drugs, including Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa Wellbutrin, Luvox and Serzone, tested in controlled clinical trials.

The warning pertains to children, adolescents and adults.

The FDA issued a Public Health Advisory on May 22, the third in two years, focusing on this increased risk of suicide in some users.

The “black box” warning is the strongest label the FDA gives a drug.

“There will have to be enough time allotted (for) the manufacturer to comply once the ruling is confirmed by the FDA,” said Laurel Eu, a field officer for the FDA in Los Angeles.

When the decision will become final is not known at this time.

“(The) FDA never puts a timeline on these decisions,” Eu said. “And the black box label is not a certainty.”

GlaxoSmithKline, the manufacturer of the drug Paxil (Paroxetine), said on Sept. 14, in a prepared statement, that the company agrees with the committee on the need to better inform patients as to the risks of the treatment. The company wouldn’t comment beyond this statement.

Litigation instances in several states, including California, have been on file since 2001. The accusations contest that GlaxoSmithCline knew about the potential withdrawal symptoms experienced when using the drug, but didn’t include a warning in the literature.

The American Psychiatric Association, (APA) commends the FDA decision. In a public statement, the APA said that the Sept. 13-14 hearing was “inclusive and thorough, and based on science and concern for patients and parents.”

The APA stressed that antidepressants were still an integral part of treatment for depression and that no care at all is the worst option.

“As of yet, the FDA has not come forth with its official decision,” said Jessica Mikulski, communications specialist for the APA in Arlington, Va. “Up to this point, the APA has only made commentary about the panel recommendations. However, you can view our official testimony submitted at the Sept. 13 and 14 hearings.” The information can be found on the APA website at www.apa.org.

Dr. David Fassler, an adolescent psychiatrist from Burlington, Vt., testified before the committee for the APA at the Sept. 13-14 hearing.

“At this point, the data is still inconsistent and inconclusive,” Fassler said. “If we just look at the studies on the treatment of childhood and adolescent depression, there are no significant differences.”

“However, if we combine these studies with those on anxiety disorders, then we find a 1.78 times increase in what’s classified as ‘suicidal thinking and/or behavior.’”

“Any increased risk of suicidal thinking or behavior must be taken very seriously. But at this point in time, there is general consensus in the clinical community that when used appropriately, the benefits of these medications far outweigh the risks.”