Recalls and warnings
A recall of American Regent caffeine and sodium benzoate injections, USP 250 mg/mL, 2 mL single dose vials due to the presence of visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation and granuloma formation.
A recommendation that crash carts, ambulances, and emergency rooms be stocked with adenosine and amiodarone in vials or pre-filled plastic syringes instead of needleless pre-filled glass syringes. Reports have indicated that the glass syringes may malfunction, break, or become clogged during the process of connection to needleless IV access systems.
A recall of Multi-Mex Distributor Inc. dietary supplements because they may be labeled as antibiotic drugs. An FDA inspection revealed the product packaging mimics antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.
A recall of Defibtech Lifeline and ReviveR automated external defibrillators, Model DDU-100 series with software version 2.004 or earlier, because a software problem may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
A warning not to feed SimplyThick, a thickening product, to premature infants because the product may cause necrotizing enterocolitis (NEC). There have been 15 reports of NEC associated with the product, including two deaths, and SimplyThick from one plant has been recalled due to failure to ensure that harmful bacteria were destroyed in the manufacturing process.
A nationwide recall of Aidapak Services repackaged medications due to potential cross contamination of non-penicillin drug products with beta lactam products that were repackaged in the same facility. There is the potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin.
A warning on the 5-alpha reductase inhibitor (5-ARI) class of drugs about an increased risk of high-grade prostate cancer. The warning is based on FDA review of two trials comparing finasteride and dutasteride to placebo which demonstrated an overall reduction in prostate cancer diagnoses but an increased incidence of high-grade cancer. Health care professionals should weigh the known benefits against potential risks when deciding to start or continue treatment with 5-ARIs in men.
A warning on simvastatin (Zocor) about the risk of muscle injury or myopathy associated with 80-mg dosing. The warning is based on an FDA review which found that the 80 mg dose has been associated with an elevated risk of myopathy compared to lower doses of simvastatin or other statins. The dose should be used only in patients who have been taking that dose for 12 months or more and have not experienced any muscle toxicity.
A reminder about the risk of thyroid C-cell tumors and acute pancreatitis with liraglutide (Victoza) injections, after an assessment showed some physicians are not fully aware of the serious risks associated with the drug. Patients taking the drug who develop thyroid nodules should be referred to an endocrinologist. Although routine monitoring of serum calcitonin is of uncertain value, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist.
A warning about medication errors in prescriptions of risperidone (Risperdal) and ropinirole (Requip) due to similarities in the product names, packaging and characteristics. In some cases, patients who took the wrong medication needed to be hospitalized. Clinicans should clearly print or spell out the medication name on prescriptions and make certain patients know the name of their prescribed medication and their reason for taking it.
A warning that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. No valid scientific data shows that thermographic devices, when used on their own, are an effective screening tool for any medical condition.
A new indication for two drugs, everolimus (Afinitor) and sunitinib (Sutent), to treat patients with progressive neuroendocrine tumors in the pancreas that are inoperable or metastatic. Patients taking the drugs survived longer without disease progression compared to those on placebo. Everolimus was previously approved to treat advanced renal cell carcinoma and subependymal giant cell astrocytoma, and under a different trade name (Zortress) to prevent organ rejection. Sunitinib was approved to treat metastatic renal cell carcinoma and gastrointestinal stromal tumor.
An expanded indication for the RX Acculink carotid stent to treat all patients with clogged carotid arteries who are at risk for stroke. The stent was previously approved for patients who had a high risk of complications from carotid endarterectomy. Approval was based on a study finding similar rates of death, stroke, and heart attack with the stent and the surgery, but the manufacturer will be required to complete post-marketing studies.
The KeyPath MRSA/MSSA Blood Culture Test, the first test that can quickly identify whether a Staphylococcus aureus infection is caused by methicillin-resistant (MRSA) or methicillin-susceptible (MSSA) bacteria. The test determines whether bacteria growing in a patient's positive blood culture sample are MRSA or MSSA within about five hours after any bacterial growth is first detected in the sample. In a trial of organisms determined to be S. aureus, the MRSA determination was 98.9% accurate (178/180) and the MSSA determination was 99.4% accurate (153/154).
Boceprevir (Victrelis) to treat adults with chronic hepatitis C who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed treatment. It is approved for use in combination with peginterferon alfa and ribavirin.
Telaprevir (Incivek) to treat chronic hepatitis C infection in adults who have either not received interferon-based drug therapy for their infection or who have not responded adequately. It is approved for use with peginterferon alfa and ribavirin, and studies indicate that treatment can be shortened from 48 weeks to 24 weeks in most patients taking the new drug.
Rilpivirine (Edurant) to treat HIV-1 infection in combination with other antiretroviral drugs in adults who are treatment-na•ve. Three clinical trials of combination therapy found rilpivirine was as effective as efavirenz in lowering viral load. Fewer patients stopped taking the drug due to side effects compared to efavirenz.
Fidaxomicin (Dificid) tablets, a macrolide antibacterial for the treatment of Clostridium difficile-associated diarrhea. Trials showed similar response to fidaxomicin compared with vancomycin and a greater number of patients treated with it had sustained cure three weeks after treatment ended. The drug should be taken two times a day for 10 days with or without food to treat infections that are proven or strongly suspected to be caused by C. difficile.
An injectable gel (Solesta) to treat fecal incontinence in adults for whom other therapies have proven ineffective. In a trial, more than half of the patients who had the gel injected into the tissue below the anal lining experienced a 50% reduction in the number of fecal incontinence episodes compared to one-third of those who didn't receive the injections.
Ezogabine (Potiga) tablets for use as an add-on medication to treat partial seizures associated with epilepsy. It is the first neuronal potassium channel opener developed for the treatment of epilepsy. The drug can cause urinary retention, neuro-psychiatric symptoms and suicidal thoughts, and was approved with a medication guide.
Redesigned drug container labels from Merck that include a new standardized format to improve readability and provide better information on product and strength differentiation. Revisions will be made to 34 container labels for 16 solid oral drugs including Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.
New restrictions were announced by the FDA for medications containing rosiglitazone (Avandia, Avandamet, and Avandaryl). The Risk Evaluation and Mitigation Strategy will limit access to rosiglitazone to patients who are already being successfully treated with it or patients whose blood sugar cannot be controlled with other anti-diabetic medications and who, after consulting with their clinician, do not wish to use pioglitazone-containing medications. As of Nov. 18, rosiglitazone-containing medications will no longer be available through retail pharmacies. To prescribe rosiglitazone under the access program, clinicians must complete a prescriber enrollment form. If a patient who has been taking a rosiglitazone medicine is hospitalized, the patient must be enrolled in the program to continue receiving the medicine; however, the patient's clinician in the hospital is not required to be enrolled.
The FDA plans to conduct a review of results from the AIM-HIGH trial, which studied whether raising HDL in patients who have a history of cardiovascular disease and well-controlled LDL could lower the rate of major adverse cardiovascular events. The trial was stopped early due to the lack of incremental benefit in patients taking extended-release niacin plus simvastatin compared to those taking simvastatin alone. A small, unexplained increase in the rate of ischemic stroke was noted in the simvastatin plus extended-release niacin group compared to the simvastatin alone group. At this time, FDA has made no new conclusions or recommendations regarding the use of extended-release niacin alone or in combination with simvastatin or other statins.
A safety review of birth control pills that contain drospirenone has found conflicting results regarding the risk of blood clots. Several epidemiological studies have reported that the risk of blood clots with drospirenone is higher than that with levonorgestrel. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.
Angiotensin-receptor blockers (ARBs) do not increase the risk of developing cancer, according to a recently concluded safety review by the FDA. The agency found no evidence of an increased risk of cancer in patients who take an ARB and concluded that the issue has been resolved by this analysis.