New drugs approved for type 2 diabetes and COPD
This regulatory update covers dapaglifozin (Farxiga) a sodium-glucose co-transporter 2 inhibitor, to treat diabetes, and umeclidinium and vilanterol inhalation (Anoro Ellipta) for maintenance of chronic obstructive pulmonary disease.
Recalls, warnings and label changes
A warning that methylphenidate medications (Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR) may in rare instances cause priapism. The warning has been added to the drug label and medication guide. Clinicians should talk to patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. Priapism appears to be even more common in patients taking atomoxetine, so use caution when considering switching patients from methylphenidate to atomoxetine.
A recall of some TRUEbalance and TRUEtrack blood glucose meters by Nipro Diagnostics, Inc. because they may have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dL.
A warning about a specific dietary supplement, Mass Destruction, that has been linked to at least 1 reported serious illness. The product contains at least 1 synthetic anabolic steroid and led to a previously healthy 28-year-old man developing liver failure requiring transplant after several weeks of product use.
A warning about over-the-counter (OTC) sodium phosphate products because using more than 1 dose in 24 hours can cause rare but serious harm to the kidneys and heart, and even death. The FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes associated with use of the drugs to treat constipation. According to the reports, most cases of serious harm occurred with a single dose larger than recommended or with more than 1 dose in a day. Clinicians should use caution when recommending an oral dose of these products for children 5 and younger, and the rectal form of these products should never be given to children younger than 2.
Dapaglifozin (Farxiga) to treat type 2 diabetes, along with diet and exercise. Dapaglifozin is a sodium-glucose co-transporter 2 inhibitor. Safety and effectiveness were evaluated in 16 clinical trials of more than 9,400 patients, which showed improvement in hemoglobin A1c. It has been studied as a stand-alone therapy and in combination with other therapies, including metformin, pioglitazone, glimepiride, sitagliptin and insulin. It should not be used to treat type 1 diabetes or patients with diabetic ketoacidosis, moderate or severe renal impairment or end-stage renal disease. The most common side effects are genital mycotic infections and urinary tract infections. An increased number of bladder cancers were diagnosed in patients on the drug, so it is not recommended for patients with active bladder cancer. It can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function.
Umeclidinium and vilanterol inhalation powder (Anoro Ellipta) for maintenance treatment of chronic obstructive pulmonary disease (COPD). The once-daily drug is a combination of umeclidinium, an inhaled anticholinergic, and vilanterol, a long-acting ß2-adrenergic agonist (LABA). Safety and efficacy were evaluated in over 2,400 patients, showing it improved lung function compared to placebo. It carries a boxed warning that LABAs increase the risk of asthma-related death and that the drug is not approved for the treatment of asthma. It may cause serious side effects, including paradoxical bronchospasm, cardiovascular effects, acute narrow-angle glaucoma and worsening of urinary retention. The most common side effects are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain and chest pain.
The FDA is warning clinicians and the public that a nipple aspirate test is not a replacement for mammography, other breast imaging tests or breast biopsy. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition. Certain manufacturers are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, the agency said. The FDA is concerned that women will believe the misleading claims and not get mammograms and/or other needed breast imaging tests or biopsies.