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Tussionex Pennkinetic FDA Alerts

The FDA Alert(s) below may be specifically about Tussionex Pennkinetic or relate to a group or class of drugs which include Tussionex Pennkinetic (chlorpheniramine/hydrocodone).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for chlorpheniramine/hydrocodone

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Jan 11, 2018

Audience: Family Practice, Pediatrics

ISSUE: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.

FDA is taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

See the FDA Drug Safety Communication for a list of prescription cough and cold medicines containing codeine or hydrocodone

BACKGROUND: Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. Other non-opioid prescription and OTC medicines are available to treat these symptoms.

RECOMMENDATION: Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.

Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children.  Codeine and hydrocodone are narcotic medicines called opioids and may carry serious risks when used in children. It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. If a cough medicine is prescribed, ask your child’s health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. Always read the labels on prescription bottles. If the medicine prescribed for your child contains an opioid, talk to your child’s health care professional about a different, non-opioid medicine, or if you have any questions or concerns.

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

[01/11/2018 - Drug Safety Communication - FDA]

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

Mar 11, 2008

Audience: Healthcare professionals, pharmacists, patients

[Posted 03/11/2008] FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

Hydrocodone in Unapproved Prescription Products

Sep 28, 2007

Audience: Healthcare professionals, pediatricians, consumers

[Posted 09/28/2007] FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products. No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.

Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.

There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult a healthcare professional for detailed guidance on treatment options.

[September 28, 2007 - News Release - FDA]

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