Skip to Content

Weekly News Round Up - December 14, 2011

Oxybutynin (Anturol) Topical Gel Approved For Overactive Bladder

Compared to oral oxybutynin, transdermal gel bypasses liver metabolism and reduces anticholinergic side effects Read More...

Overactive bladder (OAB) is a common problem in both women and men in the U.S., affecting over 33 million patients. The FDA has approved oxybutynin topical 3% gel (Anturol) in a metered-dose pump formulation for the treatment of overactive bladder. Topical instead of oral oxybutynin allows the drug to by-pass liver metabolism. Avoiding liver metabolism can reduce the incidence of side effects such as dry mouth and constipation. In a 12-week clinical trial, patients receiving oxybutynin gel experienced significantly less OAB symptoms compared to placebo, including a lower number of incontinence episodes, lower daily urinary frequency and less urinary void volume.

New Latent Tuberculosis (TB) Guidelines Issued by CDC

New U.S. TB treatment guidelines shorten the course of therapy from nine to three months Read More...

Latent tuberculosis (TB) occurs when a person is infected with TB bacteria, but does not have symptoms and cannot spread the disease to others. When the TB microbes become active, disease sets in and the person can then become contagious. The U.S. Centers for Disease Control and Prevention (CDC) has announced new guidelines that recommend a reduced treatment period in latent TB from nine to three months. Previous treatment regimens have included up to 270 days of isoniazid treatment. Adherence with these regimens is difficult, especially because patients my be asymptomatic. The new regimen entails once-a-week isoniazid for 12 weeks, along with rifapentine. Shorter regimens will strengthen the U.S. fight to avoid a TB resurgence.

Plan B One-Step Vetoed As Nonprescription Alternative for Girls Under 17

FDA determines morning-after pill is safe, effective for nonprescription use in girls under 17, but decision overruled by HHS Read More...

Food and Drug Administration (FDA) drug evaluations are based on scientific evidence. But a decision last week that Plan B One-Step (levonorgestrel) should be available on a nonprescription status for all women of child-bearing potential was overruled by U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius. Sebelius disagreed that the FDA had adequate data to support the change. Women under the age of 17 will still be required to present a prescription to access the drug at the pharmacy; women 17 and older can get it without a prescription. According to package labeling, Plan B One-Step should be taken as soon as possible within 72 hours after unprotected intercourse.

Adverse Effects to Antiestrogen Therapy May Prematurely Halt Treatment

Breast cancer patients taking antiestrogen therapies often stop therapy early due to intolerable side effects Read More...

Aromatase inhibitors, such as Arimidex, Aromasin and Femara are antiestrogen medications often prescribed to breast cancer patients with estrogen-sensitive tumors to help prevent a recurrence. A recent study suggests that many women stop treatment early due to intolerable side effects, including severe joint pain, hot flashes, decreased libido, fatigue, night sweats, or anxiety. Thirty-six percent of women stopped treatment at roughly four years instead of the recommended five. Ten percent had quit after only two years. Patients most likely to stop treatment early were those who had not fully recovered from side effects due to chemotherapy or radiation when the aromatase inhibitor was started.

FDA Advisory Panel: Drospirenone Birth Control Label Update Needed

FDA expert panel discusses added blood clot risk with drospirenone; stronger label warning suggested Read More...

Yaz, Ocella, and similar oral contraceptive pills (OCPs) that contain drospirenone have been associated with a slight increased risk of blood clot development compared to older OCPs. The absolute risk of having a clot due to OCP use is very rare, but the nature of blood clots make them a dangerous side effect. An advisory panel to the FDA suggested last week that prescription labeling for these newer pills should better reflect the risk for clots, including the fatal nature of clots. The panel noted the risk for clots appear higher in the first 3 to 6 months of drospirenone OCP use and in older women. Smoking, obesity and family history are also independent factors that increase the risk for blood clots.