[Posted 01/10/2011] ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA’s unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.
BACKGROUND: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
RECOMMENDATION: See Roxane’s “Dear Healthcare Professional Letter” for a complete description and photos of labeling and product packaging changes. Changes include:
A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.
A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.
The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.
A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.
Healthcare providers should discuss the correct use of the oral syringe with their patients.
For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for morphine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of morphine and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
What is this medicine?
MORPHINE (MOR feen) is a pain reliever. It is used to treat moderate to severe pain.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection into a muscle, vein, or under the skin. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
Always look at your medicine before using it. Do not use the injection if its color is darker than pale yellow or if it is discolored in any other way. Do not use this medicine if it is cloudy, thickened, colored, or has solid particles in it.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
This medicine may also interact with the following medications:
What should I watch for while using this medicine?
Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take this medicine for a long time.
Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.
Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help. See your dentist every 6 months.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
Keep out of the reach of children. This medicine can be abused. Keep it in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.
If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks,
and other material contained on the Healthline Site ("Content"), its services, and any information or material
posted on the Healthline Site by third parties are provided for informational purposes only. None of the
foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek
the advice of a physician or other qualified healthcare provider with any questions you may have regarding a
medical condition. Never disregard professional medical advice or delay in seeking it because of something you
have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately.
Please read the Terms of Service
for more information regarding use of the Healthline Site.
