Alert on CellCept; Solodyn, Digitek recalled


Alerts, warnings, recalls

An alert about the risk of birth defects and first-trimester miscarriages associated with the use of mycophenolate mofetil (CellCept) and metabolite mycophenolic acid (Myfortic) in pregnancy. A black box about these risks was added to the drugs last year; the recent alert is a reminder. Before prescribing the drugs, providers should confirm transplant patients are not pregnant and are using effective contraception. Birth defects after taking CellCept have included ear deformities and cleft lip and palate.

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A recall of Solodyn (minocycline) lot numbers B080037 and B080038, due to a report that one bottle contained Azasan (azathioprine) instead of Solodyn. Side effects of Azasan may include myelosuppression, infection, bleeding, chills, nausea, vomiting and diarrhea, especially in the elderly.

A boxed warning on etanercept (Enbrel) about infections. Some patients have had serious infections, including bacterial sepsis and tuberculosis, that led to hospitalization or death. Providers should screen patients for latent tuberculosis infection before beginning etanercept, and monitored for symptoms of infection during and after treatment.

A Class I recall of all strengths of Digitek (generic name digoxin) because tablets with double the appropriate thickness may contain double their approved strength. Such tablets pose a risk of digitalis toxicity in patents with renal failure; digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.

A warning not to use or purchase Mommy's Bliss Nipple Cream, because it contains chlorphenesin and phenoxyethanol, which may cause respiratory distress or vomiting and diarrhea in infants. The manufacturer said it has discontinued making the cream with these ingredients.

A precautionary recall of certain lots of Hydraglide heparin-coated thoracic drainage catheters, some of which were contaminated with oversulfated chondroitin sulfate. No adverse events have been reported. Call 1-800-5-ATRIUM for information.

A recall of Cardinal Health labeled alcohol-free mouthwash, which has been found positive for Burkholderia cepacia, a known cause of infections in hospitalized patients. At least one patient was sickened after using the mouthwash. People with weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia.

A voluntary recall of Viril-Ity Power Tabs and an alert not to use Xiadafil, both dietary supplements for erectile dysfunction that are sold online and/or at natural food stores. The products contain undeclared hydroxyhomosildenafil, which may interact with nitrates and can lower blood pressure to life-threatening levels.

Approvals

Alvimopan (Entereg), for accelerating the restoration of normal bowel function in adult patients who have undergone partial large or small bowel resection surgery. The drug will be used in hospitalized patients who can receive no more than 15 doses.

Methylnaltrexone bromide (Relistor) to restore bowel function in patients with late-stage, advanced illness who are continuously receiving opioids. The once-daily injection isn't recommended for patients with known or suspected intestinal obstructions. Common side effects are abdominal pain, gas, nausea, dizziness and diarrhea.

The ACUITY Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and pacemakers. A five-year follow-up of the lead's real-world performance is planned.

The ClariVein infusion catheter for minimally invasive treatment of peripheral vascular disease. The catheter contains a motor-driven, rotating wire to enhance fluid dispersion.

Miscellaneous

Providers should transition patients to hydrofluoralkane (HFA) propelled albuterol inhalers from chlorofluorocarbon (CFC) propelled albuterol inhalers, which will not be available after Dec. 31 due to an international environmental treaty. The HFA inhaler may feel softer, and has different priming, cleaning and drying instructions which patients should read before use.

Tropical Orange and Peach Nectar flavors of Total Body Formula and Orange/Tangerine flavor of Total Body Mega Formula contain hazardous levels of chromium. The products had already been recalled for harmful selenium levels.