US Pharm. 2007;32(7)(OTC suppl):22.
First OTC Weight Loss Drug Now Available
in Stores
GlaxoSmithKline's
alli (orlistat), the only FDA-approved weight loss product, recently hit
shelves in pharmacies, grocery stores, and mass merchandisers nationwide. alli
was approved as an OTC product in February.
"alli is not for people
looking for miracle pills and overnight results. It offers consumers a proven,
safe, OTC option to help them lose weight gradually," said Steven L. Burton,
Vice President of Weight Control at GlaxoSmithKline Consumer Healthcare. alli
is intended for use in conjunction with diet and exercise and has been
reported to help people lose 50% more weight than with dieting alone.
Once Popular OTC Contraceptive Product to
Relaunch
Today Sponge, a
hormone-free OTC contraceptive option for women, will relaunch this summer
with a new package design. Today Sponge measures only 1.75 inches in diameter
and .50 inches in thickness and fits comfortably over the cervix. The product
prevents pregnancy for 24 hours by blocking the entry of sperm into the
cervix, continuously releasing the spermicide nonoxynol 9, and absorbing sperm
in the foam sponge; it has been proven to be 89% to 91% effective in
preventing pregnancy. Today Sponge will be available in major chain drug
stores, as well as in Target, Wal-Mart, and select grocery stores.
FDA Approves New OTC Nicotine Gum
Products
The Perrigo Company
has received FDA approval to market OTC coated fruit nicotine polacrilex gum
USP, 2 mg and 4 mg, as an aid to smoking cessation. The product will be
marketed under store brand names and is expected to be available in early
2008.
The FDA has also granted
approval of Novartis Consumer Health's Thrive (nicotine polacrilex gum USP, 2
mg and 4 mg) to help smokers quit in 12 weeks. The mint-flavored gum will be
available as an OTC product nationwide in late 2007.
MiraLax Receives OTC Status
Schering-Plough
announced that prescription-strength MiraLax (polyethylene glycol 3350) is now
available as an OTC treatment for occasional constipation, making it the first
laxative to switch from prescription to OTC status in the past 30 years.
MiraLax is taken once daily
and comes in the form of a powder, which dissolves completely in any beverage
(e.g., coffee, tea, juice, soda). The product works by increasing the
frequency of bowel movements without causing unwanted side effects such as
cramps and gas.
Prescription/OTC Pain Medications Do Not
Prevent AD
The OTC pain
medication naproxen and the prescription pain reliever celecoxib do not
prevent Alzheimer's disease, according to a study in the online edition of
Neurology. These findings contradict earlier studies, which found that
sustained use of NSAIDs may have protective effects against Alzheimer's
disease.
More than 2,100 people older
than 70, who had no signs of dementia but who had a family history of
Alzheimer's disease, received daily doses of either naproxen, celecoxib, or
placebo for up to four years; most participants received treatment for less
than two years. The study found that neither drug was associated with the
prevention of Alzheimer's disease or dementia.
One explanation for the
inconsistency in these findings, compared with those of other studies, may be
that the findings of the current study relate specifically to celecoxib and
naproxen but not to other commonly used NSAIDs, said the researchers. Another
explanation may be that the drugs might not prevent the progression of the
disease in people with advanced Alzheimer's disease pathology who are
asymptomatic.
To comment on this article,
contact editor@uspharmacist.com.