FDA advisory committees turn down Primatene HFA application for OTC status
SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals’ Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.
Panelists at the joint meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee voted 18 against and six in favor of bringing what amounts to Primatene Mist — a one-time $100 million brand — back to store shelves.
A small majority (14-10) advised that the Primatene HFA inhaler was efficacious, but safety was an issue. The two panels voted 17-7 against its safety for OTC use.
The most common adverse events that occurred more frequently in more than 3% of patients were tremor, throat irritation, cough, chest discomfort and feeling jittery, according to a published report.
“OTC … provides asthmatics access without the need for additional visits to a physician’s office or to a hospital emergency room," testified David Spangler, SVP policy and general counsel & secretary for the Consumer Healthcare Products Association. "This availability especially benefits those asthmatics whose attacks are triggered by common environmental factors when immediate use may be essential. In addition, physician-diagnosed asthmatics who do not have easy access to medical care will continue to benefit from OTC use.”
I'm 54 I've been using primatine mist since it came out. It work every time 100 percent I've try all the new stuff nothing works as good as primatine mist Some body is getting paid off to keep this off the market think about all the money they are making now because u have to see a doctor. Greedy people
An asthmatic myself, I can totally emphasize. However, note that the FDA has yet to make a decision on this. The agency to this point has only brought the issue to their advisory committees — which consist of doctors and healthcare experts in the relative field. And while the predominant thinking on the advisory committees cautioned against the safety profile of Primatene, the FDA has not yet made a final decision. The general rule of thumb is that the FDA follows the advise of its advisory committees, but that doesn't always hold true. For example, the FDA recently approved the switch of Merck's Oxytrol for Women from prescription-only to over-the-counter. However, the FDA advisory committees had some months before that approval recommended against the switch.
I do NOT understand this decision by the FDA. Primatene was on the market back when generic Ventolin / Proventil were still CFA and cost less than $10.00 for those insured. When they were forced to HFA, the cost to those insured soared to over $42.00 due the delivery and Primatene was forced off the market waiting HFA. Now it is HFA and FDA won't allow it back on the OTC market? The adverse events described in the article for only 3% is identical to those described for Ventolin / Proair, etc. Also, it has been my experience that physicians will no longer simply prescribe an inhaler. They insist on prescribing an asthma controller with it, such as Advair, Symbicort, etc. that are still branded and cost a lot, all with their own side effects to consider. Something just doesn't smell right about this decision.
Survey: 4-in-5 moms turn to OTC option to treat head lice
SWIFTWATER, Pa. — A new national survey released Wednesday found that the majority of moms who have experienced head lice in their household as an adult (81%) used an OTC treatment the last time they had an infestation. Less than a third of moms (27%) chose a prescription option.
The online survey was conducted by Harris Poll on behalf of Sanofi Pasteur during back-to-school season, among more than 2,000 U.S. moms aged 25 and older. Moms define the ideal head lice treatment as one that works quickly (78%), is safe (76%) and is easy to use (74%). Approximately 67% of moms are aware of prescription treatments and 80% are aware of over-the-counter treatments. Only 32% of moms who used an OTC treatment the last time they or a member of their household had head lice say the infestation was eliminated with just one treatment; the remainder (68%) say they used two or more OTC applications to treat the infestation or report the treatment did not resolve the infestation.
The Centers for Disease Control and Prevention advises that the removal of all nits after successful treatment is not necessary and there are numerous treatment options with a range of application directions and safety profiles.
However, most moms believe that in order to get rid of an infestation you have to comb out the nits (88% of all moms and 90% of those with experience as an adult) and more than half (55% of all moms and 54% of those with experience as an adult) think that all head lice treatments require multiple applications.
Findings also demonstrate that more than three-in-four moms (77% of all moms and 89% of those with experience as an adult) believe that they know where to find reliable information about head lice — 17% turned first to a doctor, nurse or other healthcare provider and 19% turned first to a pharmacist for treatment advice the last time they had an infestation in their household.
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UrgentRx partners with Denver-area sports franchises to be ‘Official Sponsor of Game Day Relief’
DENVER — UrgentRx on Tuesday teamed up with the NFL’s Denver Broncos, the NBA’s Indiana Pacers and Kroenke Sports & Entertainment — parent of NBA’s Denver Nuggets, NHL’s Colorado Avalanche and NLL’s Colorado Mammoth — to be the “Official Sponsor of Game Day Relief.”
“Headaches, upset stomach, allergies and other common ailments often strike when you’re away from your medicine cabinet — including when you just want to enjoy the game,” said Jordan Eisenberg, president UrgentRx. “Our partnerships with these great professional sports organizations puts UrgentRx Fast Powders within reach of sports fans, so they don’t have to worry about missing that crucial shot or the game-winning goal.”
As the “Official Sponsor of Game Day Relief,” UrgentRx is delivering its over-the-counter powdered medications via various game-day promotions and in-stadium sales at Pepsi Center, Mile High Stadium and Bankers Life Fieldhouse from stadium bathroom take-overs to “lucky row” game-day relief giveaways.
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