FDA DRUG SAFETY COMMUNICATION: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

Safety Announcement
[4-20-2017] The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

As a result, we are requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond our 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. We are now adding:

FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. You can also ask your child’s health care provider or a pharmacist. Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk. These signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness. If you notice any of these signs, stop giving the medicine and seek medical attention immediately by going to an emergency room or calling 911.

Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.

Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medicines, such as acetaminophen, in prescription pain medicines. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines. Tramadol is a prescription medicine approved only for use in adults to treat moderate to moderately severe pain. However, data show it is being used in children and adolescents despite the fact that it is not approved for use in these patients.

In early 2013, FDA added a Boxed Warning to the codeine drug label cautioning against prescribing codeine to children of any age to treat pain after surgery to remove tonsils or adenoids. We also issued Drug Safety Communications in July 2015 and September 2015 warning about the risk of serious breathing problems in some children who metabolized codeine and tramadol much faster to their active form than usual (called ultra-rapid metabolism), causing potentially dangerously high levels in their bodies too quickly. At that time, we said we would continue to evaluate this safety issue. As part of that safety review, the codeine-related safety issues were discussed at an FDA Advisory Committee meeting in December 2015.

Our review of several decades of adverse event reports submitted to FDA* from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. This includes only reports submitted to FDA, so there may be additional cases about which we are unaware. We also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016 (see Data Summary). The majority of serious side effects with both codeine and tramadol occurred in children younger than 12 years, and some cases occurred after a single dose of the medicine.

In our review of the medical literature1-19 for data regarding codeine use during breastfeeding, we found numerous cases of excess sleepiness and serious breathing problems in breastfed infants, including one death. A review of the available medical literature4,5,23,24 for data regarding tramadol use during breastfeeding did not reveal any cases of adverse events. However, tramadol and its active form are also present in breast milk, and tramadol has the same risks associated with ultra-rapid metabolism as codeine.

We will continue to monitor this safety issue. We are considering additional regulatory action for the OTC codeine products that are available in some states. OTC codeine products are available in combination with other medicines for cough and cold symptoms. We are also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

We urge patients and health care professionals to report side effects involving codeine-and tramadol- containing medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Full Safety announcement can be found at https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm

FDA MedWatch – Canagliflozin (INVOKANA, INVOKAMET)

MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Increased Risk of Leg and Foot Amputations
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.
BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.
RECOMMENDATION: Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm
________________________________________
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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Centegra Hospital Huntley Laboratory Passes Initial CAP Inspection

It is with great pleasure that we announce the successful completion of the Laboratory CAP (College of American Pathologist) inspection at Centegra Hospital Huntley.  We were surveyed Monday May 1, 2017 by 8 Inspectors from various hospitals in the Midwest as well as three College of American Pathologist inspectors.

Our Laboratory successfully met the Laboratory Accreditation Program standards in all areas.  Some corrections or additions of procedures and/or policies are required and will be fulfilled within the next 30 days.  This Accreditation also meets requirements for the Joint Commission and CMS.

The surveyors were very impressed with the quality of the laboratory and the helpfulness of the leaders and the staff.  Their comments were that the laboratory provided high quality care to our patients and was very well organized.  The inspectors stated that this was the best initial inspection they participated in.

The positive outcome of the survey is directly attributed to the daily dedication to quality demonstrated by the Associates of the laboratory.  The Laboratory Leadership and Associates are congratulated on this success!

  • Wendy Ward, MD Director of Pathology & Laboratory Medicine
  • Rebecca Rockwood, Administrative Director Laboratory Services, Respiratory, Sleep and Neurology

New PhysDoc Templates Coming – Old Templates Will Be Retired

The following document templates have been updated and are scheduled for release in Paragon Live on Mon 5/15/17. Your favorites will need to be re-favorited.

  • History & Physical 1000
  • Resident History & Physical 1003
  • Medical Student History & Physical 1004
  • Progress Note 2000
  • Resident Progress Note 2003
  • Medical Student Progress Note 2004
  • Immediate Postop Note has had required field added
The following current templates will be retired on 5/15/17:
  • History & Physical Template
  • History & Physical Blank
  • Progress Note Template
  • CPC Hospitalist Progress Note Template
  • Critical Care Progress Note Template
  • Miscellaneous Template
  • Progress Note Template
  • Progress Note 2000NEW

What is a true penicillin allergy?

Did you know that most patients who give a history of “penicillin allergy” do not have a true allergy? Most of them will tolerate more effective and less expensive agents without issues.

For more information see the recently updated policy.

How to request non-formulary medication

Please note that CHS is instituting a new policy regarding the order of Non-Formulary medications.  The ordering of Non-Formulary medications will include completion of the Non-Formulary Use Request.  When requests have been completed, they are to be sent to the Pharmacy Department.  The Pharmacy Director, Dima Awad, will be reviewing all requests for approval to use.  This pertains to all Inpatient and all Outpatient (SAGE, ATC/ATS) requests.  Pharmacy will be collecting data on requests which will assist in determining the need of products for Formulary Addition.  Also included is the most recent approved Therapeutic Interchange List for your review.

Thank you very much for your consideration.

Alan Mader

Paragon Diet Orders – How to use them

When ordering a diet outside of an order set providers are taken to a screen where they can see the active diet and any supplements/modifiers for that patient. Below are directions on how to submit a new diet and discontinue a previous one. Please keep in mind that the process below is based on ordering a diet outside of an order set.

New Diet Order

    1. Search for a diet and click on the diet.

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    1. Edit information as needed; Providers can add notes, start and stop times, etc. if need be.

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    1. Click on the red “x” of the diet you wish to discontinue. If the previous order is not discontinued in the diet order detail screen, you will not be able to submit the new diet.

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    1. To submit the new diet scroll to the bottom of the page and click “submit.” *Always click submit*

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After the submitted diet has been processed by nursing, the submitted diet will be the active diet for that patient.

Things to Remember

    • You must discontinue the previous diet in the diet order detail screen before you can submit the new diet.

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    • New diet orders cannot be submitted if there is a pending diet order change. Kindly ask a nurse or patient care tech to process the pending diet order or cancel the request for the pending diet order in the Order Queue by clicking the Cancel Req button.

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