FDA May Add Suicide Warnings To Epilepsy Meds

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lyricaDrugmakers are scrambling to convince the FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, The Wall Street Journal reports.

On Monday, at a closed meeting of epilepsy researchers and industry reps in New York, the FDA presented data that agency officials said show a statistically significant difference in suicidal tendencies for patients who have taken one of 11 epilepsy drugs that are on the market. However, the difference is quite small; the risk for patients on a placebo was 0.23 percent and for those taking one of the 11 drugs it was 0.37 percent, the Journal writes.

Several drugmakers at the forum held by the Epilepsy Study Consortium told the FDA that its analysis is flawed because it grouped the results of 199 previously completed clinical studies of the 11 drugs, some of which are very different, the Journal writes. In addition, several of them are commonly used in combination. Glaxo, Pfizer and UCB made presentations.

Several execs left Monday’s conference convinced the FDA may announce new warnings about suicidal behavior soon, according to two people who attended. The FDA has scheduled an advisory committee meeting on the drugs for early July. “We did not see a signal for suicidality at all in our data base,” Steve Romano, vp global health at Pfizer, which makes Lyrica, tells the Journal, after the meeting.

Stricter warnings about Lyrica, which brought in $1.8 billion in sales last year, would hurt Pfizer, especially after new warnings on the Champix anti-smoking pill, the paper notes, adding that Lyrica was approved last year to treat fibromyalgia. Other epilepsy drugs are also used to treat chronic pain, migraines, anxiety and bipolar disorder, which boost sales.

“I think the market would look at a stronger FDA label for Lyrica as very bad, especially after we’ve watched Chantix prescriptions take a hit,” Credit Suisse analyst Catherine Arnold tells the Journal. For now, she predicts Lyrica generating $5.6 billion in sales by 2015.

Abbott, which sells Depakote, says its review of clinical trial data “shows no incremental risk of suicide-related events, but will work with the FDA to implement any label changes it recommends, according to the paper.

“I think the FDA is overreacting,” Ilo Leppik, a physician, University of Minnesota pharmacology professor and director of research at Mincep, a Minneapolis clinic for epileptics, tells the Journal. “This came out of the blue.” He believes the FDA is acting quickly because of the agency’s late response in 2004 to concerns that popular antidepressants were linked to suicide among teenagers.

However, Frank Gilliam, an epilepsy specialist at Columbia University, tells the Journal that many studies have demonstrated a connection to suicide and depression, and one key investigation suggested that nearly 10 percent of epilepsy patients suffer severe depression.

“When the base rate is 9 percent, it’s hard for me to see the importance of overemphasizing the .2 percent difference” between placebo-takers and epilepsy drug users, he tells the Journal.

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  1. “Champix”?

  2. My daughter was placed by her psychiatrist on Lamictal (Glaxo) for bipolar depression, an “approved use”. Very soon after starting the drug, she became suicidal - most pronounced before and during her monthly cycle. Very hormonal reaction. Finally tapering off the medication after close calls, she had to be hospitalized because each taper exacerbated these symptoms.

    We told Medwatch in great detail and were advised to do the same with Glaxo, which we did. I have seen concern about this suicidality on several blogs and websites, but nothing from doctors or the company.

    I hope for once the FDA will do the right thing and require prominent warnings on this whole class of drugs in a timely fashion. Months of worry, and close oversight, and luck saved her life.

  3. Once again the FDA fails the American public in its evaluation drugs

  4. I’m a little tired of the practice of slapping every possible warning on everything, to aid in the defense of drug companies, to lay the blame on the patient or the doctor.

    They were warned in bold print on a packaging insert (says the pharma defense attorney).

    Maybe the suicides are because the FDA won’t stand up for people that expect their protective body to protect them, creating hopelessness. It’s not news that MedWatch is an overwhelmed joke. But to do this means they are not planning to attempt a better process. I hope to God no one goes along with giving the FDA more money.

    Nice win pharma!

  5. And incidentally, that these warnings only come about because the drugs are being used to treat things other than epilepsy, is insulting to epileptics.

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