Discussion on Black box warning

[Guest guest]

Dear all,

I congratulate the moderator, Dr. Tarun Wadhwa, for the nice discussion. I would like to add

some information from my side.

Thanks

Dr.Shilpa N.Kaore,

Associate Prof, Dept of Pharmacology, PCMS, Bhopal

Points of consideration in BLACK BOX WARNING –

1. Important to know that BLACK BOX WARNING – is a warning highlighted in BLACK BOX ,

which denotes possibly serious side effects and risks.

2. A black box warning, is also known as a “black label warning†or “boxed warning,†is

named for the black border surrounding the text of the warning that appears on the package

insert, label, and other literature describing the medication (e.g., magazine advertising). It

is the most serious medication warning required by the FDA.

3. Medication guides – It is must when drugs are dispensed with Black box warning.

Along with a black box warning, the FDA also requires a drug company to create a medication

guide that contains information for consumers on how to safely use a specific medication. The

guides contain FDA-approved information that can help you avoid a serious adverse event.

These guides are meant to be given out by your pharmacist at the time you have your

prescription filled. The guides are also available online from the drug company and from the

FDA.

For example, the medication guide for Avandia (rosiglitazone) is available from

GlaxoKline, the manufacturer of Avandia, and from the FDA Center for Drug Evaluation and

Research.

4. Example, Antidepressant – Sertraline

The following excerpt from the prescription label of Zoloft is an

example of a black box warning.

Suicidality in Children and Adolescents -

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-

term studies in children and adolescents with Major Depressive Disorder (MDD) and other

psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a

child or adolescent must balance this risk with the clinical need. Patients who are started on

therapy should be observed closely for clinical worsening, suicidality, or unusual changes in

behavior. Families and caregivers should be advised of the need for close observation and

communication with the prescriber. Zoloft is not approved for use in pediatric patients except

for patients with obsessive compulsive disorder (OCD).

5. When Does the FDA Require a Boxed Warning?

The FDA requires a black box warning for one of the following situations:

• The medication can cause serious undesirable effects (such as a fatal, life-

threatening or permanently disabling adverse reaction) compared to the potential benefit from

the drug. Depending on your health condition, you and your doctor would need to decide if the

potential benefit of taking the drug is worth the risk.

• A serious adverse reaction can be prevented, reduced in frequency, or reduced in

severity by proper use of the drug. For example, a medication may be safe to use in adults,

but not in children. Or, the drug may be safe to use in adult women who are not pregnant.

6. What Information Does the FDA Require in the “Black Box�

The FDA requires the boxed warning to provide a concise summary of the adverse side effects

and risks associated with taking the medication. You and your doctor need to be aware of this

information when deciding to start the drug or if you should switch to another medication

altogether. Understanding side effects will help you make a better informed decision.

7. Possible concerns/ controversy over Black Box Warning …….

Many experts question if adding warnings to medicines even when the link to side effects

hasn't been proven, as in the case of antidepressants, eczema medicines, and ADHD medicines.

With so many warnings out there, won't people just start ignoring the warnings?

That is definitely one possible problem with all of the recent warnings. Many doctors and

parents may simply get so used to the warnings that they don't even consider them when

deciding if a child should take a medicine.

Adding to the controversy, with the new warnings, many experts come out against them, as in

the case of Elidel and Protopic, which are used to treat kids with eczema. Althought the FDA

added a black box warning to them, the American Academy of Dermatology issued a statement in

response to the FDA warning, saying that they disagree with the FDA and that they believe that

current research doesn't prove that Elidel (Pimecrolimus)and Protopic (Tacrolimus) are

dangerous when used properly. The SAGA continues……..

NOTE: these drugs were introduced in 2000 2001, offered relief to millions of eczema

patients.

Source -

http://drugs.about.com/od/medicationabcs/a/BlackBoxWarning.htm

http://pediatrics.about.com/od/drugwarnings/a/06_black_box.htm

Treat yourself at a restaurant, spa, resort and much more with Rediff Deal ho jaye!