Specialists in Allergy, Asthma and Sinusitis
Tomorrow, Wednesday December 4th, our offices will be closed in the morning for our annual staff in-services and holiday celebration. The Mount Laurel, NJ office, the Bala Cynwyd, PA office and the Pine Street Philadelphia office will open tomorrow at 2:40pm. The Langhorne, PA office will open tomorrow at 3pm. The Center City (205 N Broad Street) office and the Hamilton, NJ office are CLOSED tomorrow. For more specifics on shot hours, please check out your specific office's shot calendar.
Safety Concerns with Asthmanefrin and the EZ Breathe Atomizer
[9-30-2013] FDA warns patients, caregivers, and health care professionals of the potential harm of using Asthmanefrin (racepinephrine) and the EZ Breathe Atomizer. Asthmanefrin is an over-the-counter (OTC) product for the temporary relief of mild symptoms due to bronchial asthma.
FDA has received multiple adverse event reports since Asthmanefrin went on the OTC market in September 2012, including complaints of chest pain, nausea/vomiting, increased blood pressure, increased heart rate, and patients coughing up pink/red-colored sputum (hemoptysis).
In addition, a nationwide recall
was recently initiated for certain lots of Asthmanefrin Starter Kits that contained faulty EZ Breathe Atomizers that posed a choking hazard due to the possibility of a washer being dislodged during use.
Asthmanefrin’s labeling directs patients to use the product along with the EZ Breathe Atomizer, which turns the inhalation solution into a continuous vapor. Asthmanefrin solution is sold in an Asthmanefrin Starter Kit, which contains 10 filled vials and is packaged with the EZ Breathe Atomizer. Asthmanefrin is also sold in refills of 30 vials.
Asthmanefrin has not been evaluated by FDA for safety and efficacy under the new drug application process.
Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level, as a precautionary measure, due to results from our internal monitoring processes. NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. This voluntary recall will affect the following product:
Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25)
Ten (10) lots have been identified as impacted by this recall:
A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A
NPC performs aseptic process simulation as part of our internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, in accordance with published guidance regarding aseptic processing simulation from the Food and Drug Administration (FDA), NPC has decided to initiate this recall as a precautionary measure.
No other NPC products or lots are impacted by this recall.
As of July 2013, Combivent MDI will no longer be available. However, Combivent Respimat is available now. For more information on this product and a coupon good toward your first prescription, check out www.combivent.com.
There are some new medications available for treating seasonal and perennial allergies. If you would like more information on these medications, talk to your Asthma Center physician at your next appointment or visit the medication websites:
Enjoy our printable, comprehensive guide on the care and management of asthma.