FDA's MedWatch Safety Alerts for Consumers: July 2015
On this page:
- Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication
- FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs
- Unapproved Ear Drop Products Not Evaluated by FDA for Safety, Effectiveness, Quality
- Moses Lake Professional Pharmacy Recalls Human and Veterinary Drugs
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication
FDA is investigating the potential risks of using medicines with codeine to treat coughs and colds in children because of the potential for serious side effects, including slowed or difficult breathing.
Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.
The European Medicines Agency (EMA) announced in April that codeine must not be used to treat cough and cold in children younger than 12. It also said codeine isn’t recommended for children and teens between ages 12 and 18 who have breathing problems, such as asthma. FDA will continue to evaluate this safety issue and will consider the EMA recommendations.
Risk: Children, especially those who already have breathing problems, may be more susceptible to serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.
Recommendations:
Read the product label to find out whether a medicine contains codeine. Talk with your child’s health care professional or a pharmacist if you have questions or concerns.
If your child shows signs of slow, shallow breathing, difficult or noisy breathing, confusion or unusual sleepiness, stop giving codeine. Get immediate medical attention – go to the emergency room or call 911.
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 the 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
For more information:
FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs
FDA is strengthening an existing label warning that nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on its review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.
As is the case with current prescription NSAID labels, FDA will also request updates to the over-the-counter (OTC) NSAID Drug Facts labels. OTC NSAIDs are used for the temporary relief of pain and fever. Prescription NSAIDs are used to treat several kinds of arthritis and other painful conditions.
Risk: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels.
Recommendations:
When taking NSAIDs, watch for heart-related side effects. Seek medical attention immediately if you experience symptoms, such as chest pain, shortness of breath, trouble breathing, weakness in one part or side of their body, or slurred speech.
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 the 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
Unapproved Ear Drop Products Not Evaluated by FDA for Safety, Effectiveness, Quality
FDA is notifying companies to stop marketing certain unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality.
These drugs are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling.
Unapproved prescription ear drug products containing these ingredients are covered by FDA’s action:
- benzocaine
- benzocaine and antipyrine
- benzocaine, antipyrine and zinc acetate
- benzocaine, chloroxylenol and hydrocortisone
- chloroxylenol and pramoxine
- chloroxylenol, pramoxine and hydrocortisone
Risk: These drugs have not been proven to be safe or effective. These products may be contaminated or have other quality problems, which could result in patients receiving the wrong dose.
FDA has received a few reports that these products had caused local allergic reactions of the ear, eye, face, neck and mouth. They can also cause itching, stinging, burning and irritation of the ear.
Recommendations:
Contact your health care provider to discuss FDA-approved alternatives to these unapproved drugs.
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 the 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
Moses Lake Professional Pharmacy Recalls Human and Veterinary Drugs
Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs because they might not be sterile. The company has not received any reports of product contamination or adverse events.
Risk: Patients who use contaminated products could be at risk of serious infections.
The recalled products were made from July 21, 2014, through July 21, 2015. They were distributed in Arizona, Idaho, Florida, Oregon, Texas and Washington. For information on which products were recalled, see the company’s press release.
Recommendations:
Consumers should immediately discontinue using these products.
To return the product or for help with this recall, call 509-764-2314 from 8:30 a.m.-12:30 p.m. and 1-5:30 p.m. PDT Monday through Friday.
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 the 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
For more information:
August 25, 2015
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