FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market
This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
- the possibility of improper use in infants and young children
- potentially risky combinations of ingredients
- patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:
- You can visit the FDA website (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm244852.htm) for more information about this action to remove unapproved cough, cold, and allergy products from the market.
- You can find a list of unapproved products by going to (http://goo.gl/Gqc7d).
- For information on how to dispose of unused products, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.
Why is this medication prescribed?
Cyproheptadine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, irritants in the air, and hay fever. It may also be used to relieve the itching of allergic skin conditions, and to treat hives, including hives caused by exposure to cold temperatures and by rubbing the skin. Cyproheptadine is also sometimes used to treat allergic reactions in people who have received blood products as part of medical treatment and to treat life-threatening allergic reactions after the symptoms have been brought under control with other medications. Cyproheptadine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Cyproheptadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
How should this medicine be used?
Cyproheptadine comes as a tablet and a solution (liquid) to take by mouth. It is usually taken two or three times a day. Take cyproheptadine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cyproheptadine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are using the solution, do not use a household spoon to measure your dose. Use the measuring cup or spoon that came with the medication or use a spoon that is made especially for measuring medication.
Other uses for this medicine
Cyproheptadine also is used for the treatment of Cushing's Syndrome (an abnormal condition that is caused by excess hormones [corticosteroids]) and to treat certain types of headache such as migraine.Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking cyproheptadine,
- tell your doctor and pharmacist if you are allergic to cyproheptadine, other antihistamines, or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other medications for allergies or colds; medications for anxiety, depression, or seizures; muscle relaxants; narcotic medications for pain; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had asthma, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision), ulcers, difficulty urinating (due to an enlarged prostate gland), heart disease, high blood pressure, seizures, or an overactive thyroid gland.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cyproheptadine, call your doctor.
- talk to your doctor about the risks and benefits of taking cyproheptadine if you are 65 years of age or older. Older adults should not usually take cyproheptadine because it is not as safe or effective as other medications that can be used to treat the same condition.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking cyproheptadine.
- you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- talk to your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects of cyproheptadine worse.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Cyproheptadine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dry mouth, nose, and throat
- chest congestion
- excitement (especially in children)
- muscle weakness
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- difficulty urinating
- vision problems
Cyproheptadine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.