Skip to main content
U.S. Department of Health and Human Services

Consumers: Case Study 1 – Therapeutic Failure

-
-

Alfred F. (Al) is a 66-year-old (DOB 05/19/1945) retired construction worker who has been using a nasal spray for episodic treatment of allergic rhinitis, prescribed by his family doctor.

Al has had this problem for over 5 years, and it is especially troublesome in the evening because the nasal discharge and post-nasal drip interferes with falling and staying asleep. He has been using First Pharmaceutical’s nasal spray with good results for the past 5 years. The product he has received has come from one of two generic manufacturers, depending on the availability at his drug store. At the time of last refill on August 5, Al was given a new generic brand manufactured by XYZ Pharmaceutical in Texas. The product was the same 50 mcg/dose, one spray in each nostril twice daily, that he had used with previous brands of the same drug product.

Within the first several days of use, Al noticed that the medication was not having the same reliable effect that he expected and had experienced for several years with use of the same drug by a different generic manufacturer. He told his wife that the spray was “acting like distilled water instead of medicine.” He continued to use the medication twice a day, including at bedtime, as directed, but continued to have the persistent and troublesome post-nasal drainage. After several months, his wife encouraged him to speak with a pharmacist about the possibility that this generic brand was ‘different’ than his other previous brands. Al spoke with his local pharmacist about his observation that the current generic brand of his nasal spray, from XYZ Pharmaceutical, was not working.

Al was given a refill of First Pharmaceuticals’ generic nasal spray and found that his symptoms went away as soon as he began using the product. The pharmacist provided Mr. F with the lot number, 610877, the NDC number, 50383-700-16, and the expiration date 07/2013, for the XYZ product and Al submitted his report of suspected therapeutic failure to FDA’s MedWatch program.

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)



For a problem with a product, including

  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods
  • tobacco and nicotine products, including those to help you quit
  • cosmetics or make-up products
Go to Section B

For problems with a medical device, including

  • any health-related test, tool, or piece of equipment
  • health-related kits, such as glucose monitoring kits or blood pressure cuffs
  • implants, such as breast implants, pacemakers, or catheters
  • other consumer health products, such as contact lenses, hearing aids, and breast pumps
Go to Section C
(Skip Section B)
Section B – About the Product
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Do you still have the product in case we need to evaluate it? (Do not send the product to FDA.
We will contact you directly if we need it.)
Go to Section D (skip section C)
Section C – About the Medical Device
Was someone operating the medical device when the problem occurred?
If yes, who was using it?

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.):

Go to Section D
Section D – About the Person Who Had the Problem
Sex
Go to Section E
Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Did you report this problem to the company that makes the product (the manufacturer)?
May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?
-