Lindane Shampoo
and Lindane Lotion
Questions and Answers
- What is the new, important information I should know
about Lindane Shampoo and Lindane Lotion?
- Will this change how my prescription is filled at the
pharmacy?
- What is Lindane Shampoo and what does it treat?
- What is Lindane Lotion and what does it treat?
- How long has Lindane been on the market?
- How many prescriptions for Lindane are given to patients
each year?
- When should Lindane be used?
- How many times should I use Lindane Lotion or Shampoo?
- If itching persists after treatment with Lindane should
another treatment be used?
- Who should not use Lindane Shampoo or Lindane Lotion?
- How do I know if I am more likely to have side effects?
What should I tell my health care provider?
- What prompted FDA to make the changes in labeling for
Lindane Shampoo and Lotion?
- Who is at greatest risk for having side effects from
using Lindane?
- What other options are available for the treatment of
scabies or lice?
(4/11/2003)
- If a child is treated with Lindane Shampoo or Lindane
Lotion, are they never to use Lindane again?
- Are there any long term health risks if a child is under
110 lbs. and has used Lindane in the past?
- What are other possible side effects from Lindane Lotion
and Lindane Shampoo?
- How can I report a serious side effect with Lindane
Shampoo or Lindane Lotion to FDA?
- What if I have other questions about Lindane Shampoo or
Lindane Lotion?
1. What is the new, important information I should
know about Lindane Shampoo and Lindane Lotion?
The FDA is announcing important updates to the labeling of Lindane
Shampoo and Lindane Lotion. These labeling updates are based on the
information generated from FDA’s MedWatch program, a voluntary system for
reporting side effects to FDA, and reports from medical journals. The FDA
wants to update you and your caregivers using Lindane Shampoo or Lindane
Lotion that:
- serious side effects including seizures and deaths have been reported
to the FDA in patients who use too much Lindane or after a second treatment with
Lindane.
- seizures can happen in some patients even if they use Lindane as
directed.
Certain people are at higher risk to develop seizures and death from
Lindane. This includes:
- babies and children
- elderly
- people weighing less than 110 pounds (50 kg)
Serious side effects have been reported in patients who:
- used a second application of Lindane too soon after the first
- did not use Lindane as directed by their health care provider
- should not have used Lindane
- applied too much Lindane to the skin
Lindane products can cause serious side effects for many reasons, even
when used as directed. It is important for patients and caregivers to
understand how to properly use Lindane Shampoo and Lindane Lotion.
Back
to Top
2. Will this change how my prescription is filled
at the pharmacy?
Yes. The FDA and the manufacturers of Lindane Shampoo and Lindane Lotion
have worked together to make sure that this new information is shared with
health care providers, patients and caregivers to increase the safe use of
these products. When you now go to the pharmacy to get your Lindane
prescription filled or refilled, your pharmacist will give you:
This is an information sheet that highlights important safety
information. Do not forget that it is very important to read and follow
these instructions before using Lindane Shampoo or Lindane Lotion. The
Medication Guide allows you or your caregivers to take a more active role
in your treatment, especially when that drug treatment involves the
possibility of serious side effects.
- A limited amount of Lindane Shampoo or Lindane Lotion
The size of the Lindane bottle available to the pharmacy will be
reduced to either 1 ounce or 2 ounce sizes. This will control the amount
of Lindane Shampoo or Lindane Lotion that you or your caregiver can apply
at one time, and also prevent a second treatment without the supervision
of a healthcare provider.
3. What is Lindane Shampoo and what does it treat?
Lindane Shampoo is applied to the hair and underlying skin and is used to
kill lice and their eggs. Lice are very small bugs that attach to the hair
on your head or pubic (crotch) area and lay eggs, called nits, in your hair.
Lice can cause severe itching and scratching.
Since there is the possibility for serious side effects, the FDA
recommends that Lindane Shampoo only be used when you have already been treated
with other products that did not work or you cannot use other safer medications.
4. What is Lindane Lotion and what does it treat?
Lindane Lotion is applied to the skin and is used to kill scabies and
their eggs. Scabies are very small bugs that crawl under your skin, lay
eggs, and make you itch.
Since there is the possibility for serious side effects, the FDA
recommends that Lindane Lotion only be used when you have already been treated
with other products that did not work or if the you cannot use other safer medications.
Back
to Top
5. How long has Lindane been on the market?
Lindane Lotion and Lindane Shampoo have been available since the early
1950’s.
6. How many prescriptions for Lindane are given to
patients each year?
It is estimated that there are up to1 million Lindane prescriptions written each
year to treat new cases of head lice and scabies in the United States.
However, this number has been decreasing over the past few years. (From
IMS Health, National Prescription Audit Plus )
7. When should Lindane be used?
Lindane should be used only if:
- you cannot tolerate other safer treatments for lice or scabies, or
- you have used the other safer treatments, as instructed, and they did not
work
8. How many times should I use Lindane Lotion or
Shampoo?
The FDA recommends only a single treatment with Lindane. This is because
of the risk of serious side effects and even death when Lindane is applied
too early the second time. It is not known how soon after applying Lindane
that it is safe to apply a second dose. People who have used Lindane Lotion
for treating scabies should not use any form of Lindane too early, if it
indeed needs to be used again.
Sometimes, two treatments are necessary to completely treat lice. If you
suspect that the first treatment was not completely successful because you
see live lice, you should call you doctor.
Back
to Top
9. If itching persists after treatment with Lindane
should another treatment be used?
It is important to know that you may still itch after using Lindane. This
does not mean the medication is not working. Even after all the bugs are
dead, they can still make your skin itch for a few weeks. Lindane sometimes
makes this itch even worse. Talk to your health care provider about things
you can do to soothe the itch. DO NOT USE MORE LINDANE. Using Lindane a
second time may lead to serious side effects including seizures and death.
If treating lice, you should know that Lindane kills the eggs (also known
as "nits"), but it does not remove them. A special comb, called a "nit
comb," can be used to remove the dead eggs from the hair.
10. Who should not use Lindane Shampoo or Lindane
Lotion?
Talk with your health care provider. You should not use Lindane
Shampoo or Lindane Lotion if you:
- have used Lindane in the past few months. You should see your doctor
if you think that you need another treatment.
- have not tried another medicine for lice or scabies
- have a seizure disorder (convulsions, fits) or have ever had a
seizure, especially seizures that have been hard to control
- have had a bad reaction to Lindane Shampoo or Lindane Lotion before,
or are allergic to Lindane or any of its ingredients
- have open sores or crusted (scabby) sores on the skin around your head
and neck, or lots of broken skin in the treatment area
- have other skin conditions such as psoriasis or atopic dermatitis
- do not have lice or scabies. Lindane does not stop you from getting
lice or scabies. Lindane only kills the lice or scabies you already have.
- have worsening itching after using Lindane; this does not necessarily
mean that you need to reapply Lindane. Itching may worsen even when all
the lice are dead. See your doctor if this happens.
- are breast feeding. Lindane can get in your milk and may be fed to
your baby, and your baby may get sick. Lindane Lotion on your skin can
also be absorbed by your baby. If you are breastfeeding, ask your doctor
for a safer medicine.
Do not use Lindane Shampoo or Lindane Lotion on your baby. Babies are
too little and have thin skin and should not use Lindane.
Back
to Top
11. How do I know if I am more likely to have side
effects? What should I tell my health care provider?
It is difficult to know who may experience side effects, however, tell
your health care provider if you:
- have HIV or AIDS
- are pregnant
- drink a lot of alcohol
- have recently stopped drinking alcohol
- use illicit drugs
- have diabetes
- have had a head trauma, seizures, or a brain tumor
- have liver disease
- have a sexual partner and you have scabies or lice is in your pubic
(crotch) area. Your partner should be checked for scabies or lice.
- take any medications, including prescription and non-prescription
medications, vitamins and supplements. Some medications can increase your
chances of having a seizure, such as:
- Antidepressants
- Chlopromazine (Thorazine) and other antipsychotics
- Chloroquine
- Ciprofloxacin (Cipro) or penicillins
- Methocarbamol (Robaxin)
- Pemoline (Cylert)
- Promethazine (Phenergan)
- Theophylline
- Corticosteroids
12. What prompted FDA to make the changes in
labeling for Lindane Shampoo and Lotion?
The FDA uses a voluntary reporting system to help monitor and identify
serious side effects of drugs once they are on the market.
When serious side effects and misuse are reported, the FDA and manufacturers
want to minimize risks by making sure that only appropriate patients are
being prescribed the medication and then using it appropriately. We share
available information with health care providers to help them make the best
possible decisions with caregivers and patients.
Lindane products can cause serious side effects even when used as
directed. All medicines carry some risk. Yet, FDA believes that the benefits
of Lindane outweigh the possible risks in certain patients who have
exhausted all available treatment options and use Lindane appropriately.
Back
to Top
13. Who is at greatest risk for having side
effects from using Lindane?
There is increasing concern that patients weighing less than 110 pounds,
(50 kg), the elderly and babies may be more susceptible to side effects.
Babies, because of their size and thin skin may absorb more Lindane Shampoo
or Lindane Lotion and may be more at risk for serious side effects.
Reports to FDA’s MedWatch program and scientific studies suggest to FDA
that:
- Babies, because of their size and weight may be more sensitive to the
drug
- an early second treatment of Lindane to the skin may cause serious
side effects
14. What other options are available for the
treatment of scabies or lice?
(4/11/2003)
There are other medications approved by the FDA to treat scabies and
lice. In fact, Lindane should be used only after treatment with a safer
medication does not make your scabies or lice go away, or when you cannot
use safer medications. Some examples of these safer medicines used to treat
scabies and lice include the following:
Scabies:
- Crotamiton cream and lotion 10% (Eurax) - Rx
- Permethrin cream 5%, (Acticin, Elimite) - Rx
- Permethrin cream rinse 1% (Nix) - OTC
Head and pubic lice:
- Malathion lotion 0.5% (Ovide) - Rx
- Pyrethrum extract 0.33% with piperonyl butoxide shampoo (Rid) - OTC
- Permethrin cream rinse 1% (Nix) - OTC
Back
to Top
15. If a child is treated with Lindane Shampoo or
Lindane Lotion, are they never to use Lindane again?
Not necessarily, although it is known that a second treatment with
Lindane Shampoo or Lindane Lotion may lead to serious side effects. It is
still uncertain how long to wait before safely treating a second time with
Lindane.
That is why the FDA and the manufacturers of Lindane Shampoo and Lindane
Lotion want health care providers to have as much information regarding the
safe use of this product when making decisions about a second treatment for
their patients. This way the health care provider, and you or your caregiver
together can make a more informed decision with up-to-date safety
information.
16. Are there any long term health risks if a
child is under 110 lbs. and has used Lindane in the past?
The long term side effects of Lindane are not known. It is best to
discuss this with your health care providers since they can best answer this
for your own medical situation.
17. What are other possible side effects from
Lindane Lotion and Lindane Shampoo?
This is not a complete list of side effects reported with Lindane. Your
health care provider can discuss with you a more complete list of side
effects.
Lindane may cause serious side effects such as seizures (convulsions,
fits) or death. Lindane can also make you feel sleepy, dizzy, or can
cause body shaking that you cannot control.
The most common side effects of Lindane are:
- itching skin
- burning skin
- dry skin
- a skin rash
Back
to Top
18. How can I report a serious side effect with
Lindane Shampoo or Lindane Lotion to FDA?
FDA encourages anyone aware of a serious side effect, including consumers
or patients, to make a MedWatch report.
You can report an adverse event in two ways:
19. What if I have other questions about Lindane
Shampoo or Lindane Lotion?
If you have further questions regarding the program for the safe use of
Lindane products, please contact the FDA’s Center for Drug's Division of
Drug Information at: 888.INFO.FDA (888-463-6332), or email us at:
druginfo@fda.hhs.gov.
Back to Top
Back to Lindane Information
FDA/Center for Drug Evaluation and Research
Created: March 28, 2003; Last Updated: 4/15/2003
Originator: OTCOM/DLIS
HTML by SJW |