FDA issues alert for CellCept, recalls for Solodyn, Digitek

An overview of agency actions, including an alert for CellCept and recalls for Solodyn and Digitek.

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.

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 monitor 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.


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.

Seroquel (quetiapine fumarate), for use with lithium or divalproex, for the maintenance treatment of patients with bipolar I disorder. The drug is already approved for schizophrenia and for treatment of depressive episodes and acute manic episodes in bipolar I disorder.

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.

Ropinirole hydrochloride tablets—the generic version of Requip Tablets—for restless legs syndrome, in .25 mg, .5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg doses.

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

Lubiprostone (Amitiza) for adult women with irritable bowel syndrome with constipation. An 8-microgram dose is taken twice daily with food and water. Common side effects include nausea, diarrhea and abdominal pain. Less common are urinary tract infections, syncope, peripheral edema, dyspnea and heart palpitations. The drug shouldn't be used in patients with severe diarrhea or bowel obstruction.