Ask a Patient® Health News: Drugs & Treatments

The U.S. Food & Drug Administration (FDA) approved antibiotic Pivya (pivmacilliman) to treat uncomplicated urinary tract infections (UTIs) in women. While the treatment is new in the U.S., the tablet has been used in Denmark since the 1970s. The approval was granted to U.K. biotechnology company Utility Therapeutics. https://www.singlecare.com/blog/news/pivya-fda-approval/ The FDA approved Altor Immunity Bioscience’s immunotherapy drug Anktiva to treat advanced non-muscle bladder cancer.

Did you know that National Prescription Drug Takeback Day was last Saturday, April 27? If you missed it, you don’t have to wait another year: it’s not too late to dispose of your unwanted/expired drugs. To help protect our waterways and drinking water, avoid flushing* your meds down the sink or toilet unless the patient label instructs you to do so.

Plaque psoriasis drug Otezla (Apremilast) had a safety label update to provide clinical trials results that show weight loss side effect. In the trial, adults that showed weight loss of 5 – 10% of body weight occurred in 12% of patients taking the drug compared with 5% of those patients treated with placebo. In the pediatric trial of patients age 6 to 17 years old, weight decrease also occurred in 12% of subjects taking the drug compared with 2.5% of those subjects treated with placebo.

The U.S. Food and Drug Administration (FDA) approved Lumicell’s Lumisight (pegulicianine), an injected fluorescent imaging agent, for use during breast cancer surgery (lumpectomy) to aid in detection of residual cancerous tissue. This agent, along with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device, will help ensure a more thorough removal of the tumor.

Heart failure drug Entresto (sacubitril; valsartan) had a safety label update to include results of geriatric and pediatric trials. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1374 Eczema drug Dupixent (dupilumab) had a safety label update to include clinical trials results, including pediatric clinical trial results. The drug is approved for patients over the age of one.

The U.S. Food and Drug Administration (FDA) approved Invivyd’s monoclonal antibody drug Pemgarda under an Emergency Use Authorization (EUA) for prevention of Covid-19 in high-risk (moderate to severely immune-compromised) patients who have not had a known recent exposure to Covid-19. The drug is administered by intravenous infusion for at least 60 minutes. It may be repeated every 3 months as needed.

Cholesterol drug Lipitor (atorvastatin calcium) had its label updated to include the rare risk of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. Also, the instructions for the "missed dosage" section was updated:  patients are advised if they miss a dose, they should NOT take the missed dose and instead resume with the next scheduled dose.

The U.S. Food and Drug Administration (FDA) approved Madrigal Pharmaceutical's Rezdiffra (resmetirom) for patients noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). NASH, a common liver disease, is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction. It is often associated with other health problems such as high blood pressure and type 2 diabetes.

Have you ever switched from a brand name drug to a generic, or switched between generics, and found that the new drug didn't work as well or brought on new side effects? Sometimes, drug quality is the reason for bad side effects, and only laboratory testing can pinpoint the specific quality problem. But the FDA does not require routine testing of drugs entering the U.S. Inadequate inspections of overseas manufacturing facilities have also contributed to drug safety problems.

Gilead’s Covid-19 drug Veklury (remdesivir) has been approved to treat children younger than 12 (from birth on up) weighing at least 1.5kg. who are either hospitalized or are at high risk for progression to severe Covid-19.