Serzone Liver Failure

Very few patients and doctors take the time to read FDA issued label changes warning of serious and deadly Serzone side effects that can occur. Despite a Black Box warning being the strongest FDA warning issued, many doctors even admit not knowing the last time they have seen a drug label. While the FDA has been criticized for not being proactive enough when issuing warnings of possible death and serious side effects, a patient should take responsibility for reading their patient packet inserts and drug labels.

While these informational pamphlets are often hard to read with the fine print and loaded drug information, by educating yourself about the dangers and risks, as well as possible complications to be aware of, you can help prevent death or serious injury from occurring.

 

Safer Drug Use

Public Citizen's eLetter on Drugs for Severe Psychiatric Illnesses has outlined the ten rules that patients should follow to assure they take the best route to better ensure they do not needlessly suffer dangerous adverse side effects. Drugs, such as Serzone antidepressant, are associated to very dangerous side effects that certain conditions can make you more prone to becoming affected by. By taking the time to learn about the antidepressant medication that your doctor wishes to administer you can help avoid injuries that have led to instances like the Serzone liver failures.

-From Public Citizen's eLetter

Rule 1 Rule 2 Rule 3 Rule 4 Rule 5
Rule 6 Rule 7 Rule 8 Rule 9 Rule 10



Rule 1: Have "Brown Bag Sessions" With Your Primary Doctor and Fill Out A Drug Worksheet.
It is impossible to overemphasize the importance of this first and most crucial step in preventing adverse drug reactions. Whenever you go to a doctor you have not previously seen or to one with whom you have never had a brown bag session, put all prescription and over-the-counter drugs you are using, have used in the last month, or are likely to use in a bag, and bring them to the doctor so a list can be made and you can start to fill out your drug worksheet.

Doctors should never prescribe a drug or renew a prescription nor should you be willing to get a new prescription, without full up-to-date knowledge of all drugs already being taken or likely to be taken.

Before your brown bag session with the doctor, your neighborhood pharmacist may help you to fill out some of the blanks on your drug worksheet.

Once you have brought in all the drugs you are taking, ask your doctor to help you fill out the drug worksheet. You will probably be able to fill out more of the information concerning over-the-counter drugs yourself, since doctors often do not know that you are taking them or for what purpose. The doctor will be able to help you to fill out most of the information concerning prescription drugs, at least the ones that he or she has prescribed for you.

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Rule 2: Find Out If You Are Having Any Adverse Drug Reactions.
Even before you have a brown bag session with your doctor, if you develop any of the following reactions after beginning to use any drug, contact your doctor. Ask if you really need a drug in the first place and, if you do, whether a safer drug can be substituted or whether a lower dose could be used to reduce or eliminate the adverse effect.

  • Mental Adverse Drug Reactions: depression, hallucinations, confusion, delirium, memory loss, impaired thinking, and insomnia
  • Nervous System Adverse Drug Reactions: parkinsonism, involuntary movements of the face, arms, and legs (tardive dyskinesia), dizziness on standing, falls (which can sometimes result in hip fractures), automobile accidents that result in injury because of sedation, and sexual dysfunction
  • Gastrointestinal Adverse Drug Reactions: loss of appetite, nausea, vomiting, abdominal pain, bleeding, constipation, and diarrhea
  • Urinary Tract Adverse Drug Reactions: difficulty urinating or loss of bladder control (incontinence)

If you or a relative or friend have any of the above problems or develop other problems arising after starting a new drug, notify your doctor or tell your friend or relative to notify his or hers.
The remaining rules for safer drug use (or nonuse) were compiled from a number of lists, but particularly from the World Health Organization's General Prescribing Principles for the Elderly. These rules, however, apply to all age groups--and all doctors and patients who are involved in drug therapy should know them.

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Rule 3: Assume That Any New Symptom You Develop After Starting a New Drug Might Be Caused By the Drug.
If you have a new symptom, report it to your doctor.

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Rule 4: Make Sure Drug Therapy Is Really Needed.
Often, drugs are prescribed to treat situational problems such as loneliness, isolation, and confusion. Whenever possible, nondrug approaches to these problems should be tried. These include hobbies, socializing with others, and getting out of the house. When a person is suffering from an understandable depression after losing a loved one, for example, support from friends, relatives, or a psychotherapist is preferable to drugs such as antidepressants.

Mild anxiety or difficulty sleeping are two situations for which drug therapy is rarely, if ever, appropriate. Severe anxiety, however, is a common symptom of many severe psychiatric disorders and is commonly and successfully treated pharmacologically.

For any condition, always consider and discuss with the doctor whether the drug that is being selected may cause problems (side effects) worse than the disease being treated. A very common example of this is the extraordinary over-treatment of older people with slightly high blood pressure but without any symptoms of or problems caused by high blood pressure. In most cases, the person will feel worse because of the treatment, without any evidence of benefit. Always consider the seriousness of the condition which your doctor is considering treating, and try to make sure that the treatment is not worse than the disease.

The guiding principle is to use as few drugs as possible, in order to reduce adverse reactions and increase the odds of properly taking the ones that are really necessary.

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Rule 5: If Drug Therapy Is Indicated, In Most Cases, Especially in Older Adults, It Is Safer To Start With a Dose That Is Lower Than the Usual Adult Dose.
"Start low, go slow." The lowest effective dose in any patient is always the best, because a lower dose will cause fewer adverse effects, which are almost always related to dose. In the elderly, some experts suggest starting with one-third to one-half of the usual adult dose for most drugs and watching for side effects, increasing the dose slowly and only if necessary to get the desired effect.

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Rule 6: When Adding a New Drug, See If It Is Possible to Discontinue Another Drug.
If your doctor is considering the addition of a new drug, this should always be used as an opportunity to reevaluate existing drugs and eliminate those that are not absolutely essential. The possibility of an adverse drug interaction between the new drug and one of the old ones may force dropping or changing a drug.

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Rule 7: Stopping a Drug Is As Important As Starting It.
Regularly review with your doctor, at least every three to six months, the need to continue each drug being taken. However, many, if not most individuals with schizophrenia, manic-depressive illness, and severe recurrent depression must continue taking medication for many years. The prevailing principle for doctors and patients should be to discontinue any drug unless it is essential. Drugs which were continued long after any rational duration of use ended cause many adverse drug reactions. Many drugs such as antidepressants, sleeping pills, tranquilizers, digoxin and others that are prescribed for an acute problem are not needed beyond a short period, and cause risks without providing benefits. Slow and careful weaning off these drugs may significantly improve the user's health. In addition to considering whether to stop the drug, you and your doctor should discuss the possibility of lowering the dose.

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Rule 8: Make Sure Your Drug-Using Instructions Are As Clear As Possible To You and At Least One Other Person.
Regardless of how old someone is, the chance of adverse reactions is high enough that at least one other person--a spouse, child, or friend--should know about these possibilities. In the presence of such adverse reactions as confusion and memory loss, this is especially critical. For older adults, the complexities of drug use may be greater, especially for people taking more than one drug and people with physical or mental disabilities. In these cases, it is even more important to inform another person about possible adverse drug reactions.

Ask your doctor to make sure that the label on the drug states, if at all possible, the purpose for which the drug is being used. This is especially important when you are using multiple drugs, but is always important as a way of increasing your and your family or friend's participation. All information concerning the proper use of the drug should also be on the label. In addition to the label, you should get a separate instruction sheet and have it explained to you.

In the case of Serzone antidepressant, the FDA added many warning and risk indications onto the Serzone labeling. It has been found that many patients and doctors are guilty of not reading through the drug information and patient pamphlets. In the case of Serzone, Black Box warnings were added to the antidepressant labeling warning of the potential Serzone liver failure that has been found to occur.

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Rule 9: Discard All Old Drugs Carefully.
Many people are tempted to keep and reuse drugs obtained in the past, even though reasons for their use have changed. Additional drugs used may make the earlier drugs much more dangerous. In addition, you may be tempted to give drugs to a friend or relative whom you believe may benefit from them. Resist these temptations and avoid further problems caused by using outdated drugs, by throwing them away when you are done with your course of therapy.

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Rule 10: Ask Your Primary Doctor to Coordinate Your Care and Drugs.
If you see a specialist and he or she wants to start you on new medicines in addition to the ones you are on, check with your primary doctor first--usually an internist or general or family practitioner. It is equally important to use one pharmacist, if possible.


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Dangers of Serzone
The type of liver damage Serzone can cause ranges from asymptomatic reversible increases in serum transaminase to serious cases of liver failure. Liver damage that leads to instances of liver failure resulting in transplant and/or death has been associated to the use of Serzone antidepressant.
What is a Black Box Warning?
The FDA issues Black Box warnings when a drug is associated to a high risk of serious and deadly side effects. This type of warning is the strongest warning possible. Serzone's manufacturer, Bristol-Myers, was told in December 2001 that their antidepressant drug must include a Black Box to warn patients of the "life-threatening hepatic failure" that had been reported. The "black box" refers to the thick black outline that surrounds the warning.