FDA Safety Changes: Hycodan, Lotensin, Lotensin HCT, Omnicef

Yael Waknine

March 18, 2009

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March 18, 2009 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to warn against use of hydrocodone bitartrate plus homatropine methylbromide products in children younger than 6 years, drug interactions between angiotensin-converting enzyme inhibitors and injectable gold therapy, and the potential for the development of Clostridium difficile–associated diarrhea more than 2 months after completion of antimicrobial therapy.

Hydrocodone/Homatropine Tablets ( Hycodan) Contraindicated in Young Children

On January 16, the FDA approved safety labeling revisions for hydrocodone bitartrate and homatropine methylbromide tablets and oral solution (Hycodan; Endo Pharmaceuticals, Inc) to warn against their use in children younger than 6 years.

According to the FDA, postmarketing cases of unintentional overdose, bronchopneumonia, coma, cyanosis, death (including neonates), dyspnea, pulmonary arrest, respiratory arrest, and respiratory depression have been reported in young children treated with the product.

In pediatric patients, as well as in adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner, the FDA warned. Because of the risk for fatal respiratory depression, caution is advised when administering hydrocodone/homatropine to children 6 years and older.

Overdose or concomitant administration of opioids with other respiratory depressants can increase the risk for respiratory depression. Benefit-to-risk ratio should be carefully considered, particularly in those with respiratory conditions (eg, croup). If respiratory depression occurs, it may be antagonized by treatment with naloxone HCl and other supportive measures as needed.

Hydrocodone bitartrate and homatropine methylbromide tablets are indicated for the symptomatic relief of cough in adults and children 6 years and older.

ACE Inhibitor Drug Interaction With Injectable Gold Linked to Nitritoid Reactions

On January 22, the FDA approved safety labeling revisions for benazepril HCl tablets and benazepril plus hydrochlorothiazide tablets (Lotensin and Lotensin HCT; Novartis Pharmaceuticals Corp) to warn of drug interactions with angiotensin-converting enzyme (ACE) inhibitors such as benazepril.

According to the FDA, nitritoid reactions have been reported rarely in patients receiving concomitant treatment with injectable gold (sodium aurothiomalate) and ACE inhibitors. Symptoms may include facial flushing, nausea, vomiting, and hypotension.

Intramuscular gold therapy is used to treat rheumatic diseases such as rheumatoid and psoriatic arthritis and is generally reserved for patients who show evidence of continued or additional disease activity despite conservative drug therapy with salicylates or other anti-inflammatory agents.

Benazepril and benazepril plus hydrochlorothiazide tablets are indicated for the treatment of hypertension.

Cefdinir (Omnicef) Safety Label Updated

On December 15, 2008, the FDA approved safety labeling revisions for cefdinir tablets and oral suspension (Omnicef; Abbott Laboratories) to warn of the risk for Clostridium difficile–associated diarrhea (CDAD) in patients receiving antibiotic therapy.

Use of antimicrobial agents can alter the colon's normal flora, leading to overgrowth of C difficile and subsequent release of toxins A and B that contribute to the development of CDAD. Nearly all antibiotics have been implicated in CDAD, which may range in severity from mild diarrhea to fatal colitis.

Because hypertoxin-producing strains of C difficile can be refractory to antimicrobial therapy, they are associated with increased morbidity and mortality rates and may require colectomy. The FDA advises that CDAD be considered in all patients who present with diarrhea after antibiotic use. Careful examination of medical history is required because of the potential for late-onset disease; cases of CDAD have been reported more than 2 months after completion of an antimicrobial course of therapy.

The FDA notes that current antibiotic therapy for the primary infection may need to be discontinued in patients with known or suspected CDAD. Appropriate fluid and electrolyte management, protein supplementation, antibiotic therapy for C difficile, and surgical evaluation also may be required.

Cefdinir is indicated for the treatment of infections caused by susceptible strains of designated microorganisms. Adult applications include community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute maxillary sinusitis, pharyngitis/tonsillitis, and uncomplicated skin/skin structure infections. Cefdinir may also be used to treat acute bacterial otitis media, pharyngitis/tonsillitis, and uncomplicated skin/skin structure infections in children.

Hycodan Prescribing Information

Omnicef Prescribing Information

FDA Safety Information


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