Wednesday February 27, 2013
Postmenopausal women who experience pain during intercourse -- a condition called dyspareunia
-- have a new treatment option with Shionogi Inc.'s Osphena (ospemifene).
The U.S. Food and Drug Administration approved the once-daily pill on February 26, 2013
. The drug acts like estrogen without replacing the hormone, which has been the treatment of choice for reducing incidences of painful sex following menopause.
Even though Osphena is neither estrogen nor a hormone-replacement therapy, it has many of the same potential side effects and adverse events
as the older treatments. Labeling for Osphena emphasizes that women should take the medication for the shortest period necessary to produce benefits like thickening and strengthening vaginal and vulvar tissues. The label also includes black box warnings about risks for deep-vein thrombosis, strokes and endometrial cancer
Osphena can damage a developing fetus, so it should never be used during pregnancy. The medication should also not be prescribed or dispensed to women with estrogen-sensitive cancers, undiagnosed genital bleeding or blood clots.
Full prescribing information for Osphena
is available online.
Editorial Note: This will be the last blog post for a while. I have been offered another professional opportunity that is too pass up and which will make writing and editing this blog and website impossible. About.com should begin looking for a new pharmacy guide soon. Thanks for reading.
Sunday February 17, 2013
Any pharmacy or health and wellness store stocking SlimXtreme, SlimPlus, SlimLee, GetSlim, SlimDrops or Colonew should stop selling the weight loss aids immediately.
The U.S. Food and Drug Administration announced on Feb. 14, 2013, that U.S. marshals had seized all unshipped packages of the products from Globe All Wellness
. Analyses and inspections by FDA officials found that the company had used the prescription-only drug sibutramine when formulating its products. It also failed to follow current good manufacturing practices required for dietary supplements.
Sibutramine was the active pharmaceutical ingredient in Abbott Laboratories' diet drug Meridia
. Abott withdrew Meridia
from the market in 2010 after evidence emerged that patients taking the medication had significantly increased risks for suffering debilitating and fatal heart attacks and strokes.
FDA considers the seized weight loss supplements from Globe All to be both unapproved and counterfeit drugs under federal law. The products were sold primarily through the company's website, which has been taken down, and through online pharmacies
A warning letter sent to Globe All
in early 2012 alerted company executives that they would face administrative and legal penalties if they did not resolve identified production, drug approval and product safety issues. The enforcement actions taken last week indicate that necessary improvement were not made.
This incident is just the latest example that should remind patients that dietary supplements
can be as risky as prescription and OTC drugs. In addition to ridding their pharmacies of all Globe All products, pharmacists and pharmacy technicians should consider taking this opportunity to offer counseling on supplement use.
Product package image courtesy of FDA
Sunday February 17, 2013
The detection of particulates in some vials from a single lot of Vistide (cidofovir injection)
has led Gilead Sciences, the medication's manufacturer, to recall the potentially contaminated products.
Vials from the affected lot bear the production code B120217A
and a May 2015 expiration date. Gilead informed the U.S. Food and Drug Administration that the recalled products had been delivered to community pharmacies, drug wholesalers and hospitals in the United States, Europe and Canada.
Generic versions of cidofovir injection and other lots of Vistide can remain in stock. However, any injectable medication should be visually inspected
before administration. If any unusual cloudiness or discoloration is detected, the drug in question should not be given to a patient. Preliminary reports on the tainted steroid injections prepared by the New England Compounding Center indicate that the vials should not have passed a "looks" test.
is a viral infection of the retina at the back of the eye. It most often becomes symptomatic in people with weakened immune system. Untreated or mistreated, the disease can cause blindness. Adding to potential problems, particles in injected medication can lead to other infections and life-threatening blood clots.
Pharmacies and other health care facilities that have recalled Vistide can contact Stericycle at (888) 965-5791 to get information on returns and refunds.
Gilead is also accepting questions from pharmacists, doctors, nurses and patients at (800) GILEAD-5, which is also (800) 445-3235.
Any serious or unexpected side effects or adverse events from any medication should be reported to FDA's MedWatch
Product package image courtesy of DailyMed
Monday February 11, 2013
Any pharmacies stocking Rad Block KI potassium iodide dietary supplements
or 600 mg enteric-coated guaifenesin tablets produced by Titan Medical Enterprises should remove the products from their shelves immediately.
The U.S. Food and Drug and Drug Administration on Feb. 4, 2013, won a federal cease-and-desist order against Titan Medical after nearly a decade's worth of inspection showed that the drugmaker persistently failed to comply with current good manufacturing practices
for its supplements and medications. The agency also determined that the company had failed to receive approval for its version of guaifenesin.
The only FDA-approved guaifenesin products are a generic made by Perrigo and the brand name nonprescription cough and cold medicine Mucines from Reckitt Benckiser
The full text of the five-page summary judgment against Titan Medical
is available online. The company could potentially return to producing and marketing supplements and drugs if FDA certifies that Titan Medical has resolved all identified problems, particularly in regards to certifying the purity and regulatory status of the active pharmaceutical ingredients
and supplement ingredients it uses.
According to Acting Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, her agency "continues to take strong enforcement actions against companies that fail to comply
with federal drug and dietary supplement manufacturing regulations. The actions we are taking are necessary to make sure that the drugs and dietary supplements consumers purchase have been manufactured in compliance with cGMP."
When pharmacists and pharmacy technicians
learn of such enforcement actions, they owe it to patients to stop selling and dispensing affected products.
Illustration courtesy of DTR