New Drug Update 2009-2010 - LAFP

• Change the name of Maalox Total Relief to one that will not include the name "Maalox" and
revise the graphics and information displayed on the front of the product container to help
distinguish the active ingredients and uses of this product from the traditional Maalox antacids.
• An educational program that includes outreach to healthcare professionals and consumers to
inform them about the different products sold under the Maalox brand, including how to select the
appropriate Maalox brand product.
The company expects to begin selling the renamed product in September 2010. Until that time,
healthcare professionals and consumers should be aware of the following:
• Maalox Total Relief contains the active ingredient bismuth subsalicylate and is used to treat
diarrhea, upset stomach associated with nausea, heartburn, and gas due to overindulgence in
food (overeating).Bismuth subsalicylate is chemically related to aspirin and may cause similar
adverse effects such as bleeding. Bismuth subsalicylate has a warning statement stating that it
should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding
disorder.
• The traditional Maalox liquid products including Maalox Advanced Regular Strength and Maalox
Advanced Maximum Strength are well-recognized antacid drug products that contain aluminum
hydroxide, magnesium hydroxide, and simethiconeMaalox Total Relief should not be confused
with traditional Maalox liquid antacid products.
FDA is concerned about the public health impact of medication mix-ups with products that have the same
names or portions of the same name but contain different active ingredients. The agency encourages
drug companies to consider the potential for name confusion when choosing OTC product names.
February 18, 2010 FDA Drug Safety Communication: New safety requirements for long-acting
inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk
management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised
Medication Guide written specifically for patients, and a plan to educate healthcare professionals about
the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an
increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and
adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
• Single-ingredient LABAs should only be used in combination with an asthma controller
medication; they should not be used alone.
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled
on asthma controller medications.
• Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid
should use a combination product containing both an inhaled corticosteroid and a LABA, to
ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential
risks when used appropriately with an asthma controller medication in patients who need the addition of
LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs.
American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting. We are
concerned with the FDA's recommendation that after asthma control has been achieved with a
combination of LABAs and inhaled corticosteroids, LABA use should be stopped as soon as possible.
“Their recommendations really run counter to our guidelines." They also state that combination therapy
has been very effective, showing decreased morbidity, hospitalizations, and exacerbations. "The indices
of safety that have been raised [by the FDA] really do not appear in the literature, and we really need to
see new data before making dramatic changes in our recommendations." In addition, the AAAAI "does
not want to see insurers or pharmacy benefit managers erecting more barriers because of this
recommendation that will result in patients going out of control or becoming unstable before a physician
or healthcare provider can continue their medication,"
February 19, 2010 FDA approves Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide
Diphtheria CRM197 Conjugate Vaccine - Menveo
For active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis
serogroups A, C, Y and W-135 when administered to individuals 11 through 55 years of age.
• Menveo consists of a liquid vaccine component (MenCYW-135 liquid conjugate component) and
a lyophilized vaccine component (MenA lyophilized conjugate component). Reconstitute the
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