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:
Certain people are at higher risk to develop seizures and death from Lindane. This includes:
Serious side effects have been reported in patients who:
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.
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.
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.
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.
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.
Lindane Lotion and Lindane Shampoo have been available since the early 1950’s.
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 )
Lindane should be used only if:
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.
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.
Talk with your health care provider. You should not use Lindane Shampoo or Lindane Lotion if you:
Do not use Lindane Shampoo or Lindane Lotion on your baby. Babies are too little and have thin skin and should not use Lindane.
It is difficult to know who may experience side effects, however, tell your health care provider if you:
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.
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:
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:
Head and pubic lice:
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.
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.
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:
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:
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: email@example.com.
FDA/Center for Drug Evaluation and Research