Lindane Shampoo and Lindane Lotion- Questions and Answers

1. What is the new, important information I should know about Lindane Shampoo and Lindane Lotion?
2. Will this change how my prescription is filled at the pharmacy?
3. What is Lindane Shampoo and what does it treat?
4. What is Lindane Lotion and what does it treat?
5. How long has Lindane been on the market?
6. How many prescriptions for Lindane are given to patients each year?
7. When should Lindane be used?
8. How many times should I use Lindane Lotion or Shampoo?
9. If itching persists after treatment with Lindane should another treatment be used?
10. Who should not use Lindane Shampoo or Lindane Lotion?
11. How do I know if I am more likely to have side effects? What should I tell my health care provider?
12. What prompted FDA to make the changes in labeling for Lindane Shampoo and Lotion?
13. Who is at greatest risk for having side effects from using Lindane?
14. What other options are available for the treatment of scabies or lice? (4/11/2003)
15. If a child is treated with Lindane Shampoo or Lindane Lotion, are they never to use Lindane again?
16. Are there any long term health risks if a child is under 110 lbs. and has used Lindane in the past?
17. What are other possible side effects from Lindane Lotion and Lindane Shampoo?
18. How can I report a serious side effect with Lindane Shampoo or Lindane Lotion to FDA?
19. 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.

 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:

• The Medication Guide

• A limited amount of Lindane Shampoo or Lindane Lotion

 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.

 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.

 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.

 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.

 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

 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

 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 either online, by regular mail or by fax, using the contact information at the bottom of this page.

 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.