Warning on Medications, Drugs, Etc.

[Harrison]

Almost missed this important notification! Please read.

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning.

The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Rufinamide (marketed as Banzel)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
Zonisamide (marketed as Zonegran)

Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

-- Online : www.fda.gov/MedWatch/report.htm
-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787
-- Fax: (800) FDA-0178
-- Phone: (800) FDA-1088

[Harrison]

Hi everyone, I am posting this by the request of a member who prefers anonymity. If you would, offer your support and suggestions, thanks.
______________________________________________

Thanks for your post on FDA warnings; re the suicidal thoughts. I have found myself thinking of ending my life recently (since I started Pregablin) and the thoughts are regular and sustained. I have talked to my friends too, and said to them how I feel and they are worried but I am not!

I take Pregablin because I think that without it, my pain would be unbearable. I can’t imagine coming off it. I am not intending to kill myself but the thoughts are there. I have just started back to work so don’t want to bring this issue to my doctor’s attention. My husband is aware and is watching for any indication I am worsening in my thoughts. Is there any body you know of who can give me info and advice?

[phylly]

Hello,

My only thought on this is that sometimes one med can have a different effect on mood than another. When I tried Lyrica I felt very depressed so I switched to nuerontin. I know they act similarly on the nerves but they may act differently on moods and feelings. Perhaps if you speak with your Dr. about switching to a different drug because you don't like how it makes you feel without going into the suicidal thoughts might help.

When I spoke to my Dr., he was happy to try a different medication. We often have to experiment a little to get the rights meds for each individual as we are all different.

Phylly

[Adrienne]

I had a weird experience on pregabalin as well. The Dr. said to take it only at night in the beginning. Slept great. But every day, around lunchtime I'd get powerful waves of emotion, usually negative. Anger, despair, rage etc. I'm typically very even tempered...you'll just have to take my word for it.

This anger would be totally inappropriate to the exigent occasion. I be, say, in the lunch line and want to sob because I didn't like chicken tetrazini. One day at a football game my husband of twenty years returned with my hot dog and had deigned to take a bite out of it. I was ENRAGED. I swear, I loathed the man. Couldn't even look at him. It was totally about the hot dog.

Every day, around noon, I'd detest whatever, whomever was around me. My friends, my car, my bank..you name it.
Whatever emotion I was having was magnified way over my capacity to handle it. A mere annoyance would become rage.

Finally figured out it was the lyrica. I was only taking it at night and I think this was a mini-withdrawl, as the levels lowered. I stopped and so did the lunch time massacres. But if that anger were directed inwardly, it would have translated to suicidal thoughts. The point is, I never acted on these waves of emotion....you could have stood right next to me and had no idea I loathed your guts. I didn't have any desire to act out; it wasn't part of the experience at all.

Maybe because it was anger without the bodily sensation of it. No increased heart rate, muscle tightness, etc. Hard to explain but, hopefully, your reaction is the same in that you have no desire to act out your feelings.

Take care, and be sure to keep your husband and friends advised. Great that you have them.

Adrienne

[Harrison]

Thank you for posting this! I must say, I am getting an education here too -- I am saddened and surprised with the intensity of the emotions you described. Oh my gosh!

In the commonality of experiences, I wonder if there is one causal factor that could be isolated? I hope someone is working on this problem. In the meantime, thanks for sharing.

Also see this article from earlier this year, which appeared in the Wall Street Journal.

[CindyLou]

I would highly recommend seeing a psychiatrist. Even if you can't afford it. Do it. Because suicidal ideation and actually coming up with a plan, any plan, can be a very thin line, and happen quickly, actually. The fact that your friends are worried and you are not is also telling. You're not worried, but you're actually telling them that you have been thinking of suicide. So, even the "talk" of it is becoming benign in your thoughts, instead of alarming, as in your friends' thinking. You need more than your husband, who can't watch you every minute, to be on your team.

God Bless you, and confide, confide, confide. I will keep you in my thoughts and prayers.

Cindy

[treefrog]

Yes this is very concerning. I agree that you need to talk to your doctor about switching medications, that is if you haven't already tried Neurontin and found it didn't work for you.

And talking to a psychiatrist is a good idea too. There may be another drug that you could take, to counteract the effects of the Lyrica.

I really hope you find something to get rid of these thoughts.

[Sandra L]

Please talk to your doctor about changing to something else. Your doctor should be able to be trusted and not cause any problems at work. Been through a suicide with a young person and having my daughter on a 24 hour suicide watch as well as seeing a professional, I can't tell you how important this is. Nothing is more important, make this a priority. I don't mean to put the burden all on you, but you can't imagine how your husband and family would suffer if you were to act on your feelings. Please see your doctor or a psychiatrist. You are in my thoughts and prayers. Sandy

[Harrison]

FDA panel recommends ban on the painkiller Darvon

[Harrison]

Postop painkillers linked to deaths after spinal fusion

April 14, 2009

A recent study links painkillers to one in five deaths among people who have had lumbar fusion surgery to help relieve lower back pain. Among this group, middle-aged men with degenerative disc disease (DDD) ran a sevenfold greater risk of either accidental or suicidal analgesic poisoning compared to the other surgical patients, according to a press release.

The findings raised questions among the researchers about the effectiveness of the surgery and the postop medications. Spinal fusion has become more popular in recent years despite being riskier than less-complicated back surgeries aimed at reducing pain, they said in the press release.

The study, published in the April 1 issue of Spine, included nearly 2,400 patients who had spinal fusion surgery between 1994 and 2001.
Of the 103 patients who died in the 3 years following surgery, 21% involved either accidental overdose or suicide involving pain medications. These fatalities tended to be younger surgical patients, while older ones were more likely to die of cancer, heart disease or other causes.

“Analgesic-related deaths are responsible for more deaths and more potential life lost among workers who underwent spinal fusion than any other cause,” lead researcher Sham Maghout Juratli, MD, MPH, of Wayne State University School of Medicine in Detroit, said in the news release. The researchers said patients with DDD, especially the highest-risk category of 45- to 54-year-old men, should be monitored carefully after surgery and be given extra attention to help reduce risk of mortality.

Reference:

Juratli SM, Mirza SK, Fulton-Kehoe D, et al. Mortality after lumbar fusion surgery. Spine. 34;7:740-747.

Courtesy of OrthoSupersite:
http://www.orthosupersite.com/view.asp?rID=38923