FDA Warns Bayer About Two Unapproved Aspirin Products
What action is FDA announcing?
On Oct. 28, 2008, the Food and Drug Administration (FDA) sent warning letters to Bayer HealthCare regarding two over-the-counter (OTC) products that combine aspirin with a dietary supplement into a single pill. The products are not approved by FDA.
Which products are affected?
- Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)
- Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s)–aspirin combined with calcium
Why is FDA issuing these warning letters?
In addition to marketing these products as pain relievers, Bayer is also marketing them for reducing the risks of heart disease. The labeling for Bayer Women’s also claims that the product helps “fight” osteoporosis.
- The products are unapproved new drugs. Because these products combine aspirin with a dietary supplement into one pill, FDA considers them to be new drugs that must undergo FDA review before they can be marketed. Their safety and effectiveness for their marketed uses have not been reviewed by the agency.
Under the OTC Drug Review–a process that lays out ingredients and uses that are allowed in OTC products–FDA allows some drugs to be marketed without first obtaining formal agency approval. But Bayer Heart Advantage and Bayer Women’s are not covered by FDA’s OTC Drug Review, nor are they otherwise approved by the agency.
- Bayer is marketing the products over-the-counter, but their use requires a physician’s supervision. Products that are being marketed for preventing heart attacks, for preventing and/or treating heart disease, and/or for treating osteoporosis require the supervision of a physician to ensure safe use.
- The products have inadequate and misleading directions and warnings. Both products lack adequate directions and warnings for their safe use by consumers. For example, these products are labeled with directions and warnings that are inconsistent and contradictory.
The “Drug Facts” panels on the labeling for these products specify that consumers should stop use and ask a doctor if pain gets worse or lasts more than 10 days. But the “Supplement Facts” panels on the labeling for these products include directions for daily use, without mentioning any limitations on duration of use.
Have there been adverse events related to these products?
FDA is not aware of significant adverse events related to these products. But the agency is concerned because Bayer Heart Advantage and Bayer Women’s have not been proven safe and effective for their labeled uses.
What is FDA’s advice for consumers who may have been taking these products?
FDA has not approved these products. The agency recommends that consumers talk with their health care providers about alternatives to taking an unapproved drug. Consumers who are taking any aspirin products for cardiovascular health should only do so under the supervision of a physician.
Why is it important to use aspirin products under the supervision of a physician?
Studies have shown that aspirin can help prevent the recurrence of heart attacks and stroke, but aspirin use has also been associated with adverse events. These include gastrointestinal side effects, such as stomach pain, heartburn, nausea, vomiting, and bleeding. Also, using aspirin for cardiovascular health may not be necessary or appropriate for some people.
This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
American Diabetes Month and World Diabetes Day
November is American Diabetes Month. My family is well acquainted with diabetes. In July, my father lost his battle with diabetes. My older sister has diabetes. I was originally told that I was “insulin resistant.” Diagnosis of insulin resistance or pre-diabetes may not seem like a big deal, but make no mistake: it is the beginning of an assault that will escalate, if given the chance. My insulin resistance turned into a diagnosis of diabetes several years ago.
My dad had to test his blood and give himself daily insulin shots. His kidneys began to fail and every night he hooked himself up for 8-10 hours of peritoneal dialysis. The nerve damage in his hands eventually prevented him from doing activities that required manual dexterity. He could no longer feel his feet and he became very unstable when walking. He was in and out of hospitals with a host of heart and respiratory issues. His circulation worsened. He got gangrene in his right foot and had to
have his leg amputated. He had started trying to regain his strength and to heal from the amputation when he died at a rehabilitation facility.
My dad went through a lot, but diabetes doesn’t just affect the person with the disease, it affects the whole family. My mom had to learn to cope with my dad’s extreme high and low sugar levels and near-death cardiac crises. My mother’s intervention saved my dad’s life on more than one occasion. She had to learn to manage his medicines and perform his dialysis hook-up when circulatory-related dementia set in and he could no longer remember how to safely perform his health maintenance routines. She had to deal with a host of logistics from getting him up when he fell to getting him to all of his doctor appointments. I know that this was tremendously stressful
for her.
It was a very difficult thing watching my dad trying to cope
with the pain of the amputation. My dad
was “old school” in his belief that men don’t cry. To witness him shaking with pain and trying
not to cry in front of his daughters was something that will stay with me
forever. Watching him joke with the
nurses and trying to keep a positive attitude when I know he must have been
scared confirmed for me that he was a brave person in his own way.
As a diabetic, I can tell you that it can be difficult to deal with emotionally. It is a struggle sometimes to maintain a positive attitude and keep focused on good eating, exercising, and disease-monitoring habits. Depression or despondency can cause disease control and good habits to slip away and when that happens, diabetes infiltrates and does more damage.
Diabetes is not easy to manage or live with, but diabetics don’t have to do it all alone. Working with a good health
care team can help manage and control the disease, but it is crucial to get
control of the disease as early as possible. The American Diabetes Association is a good resource for anyone who has been recently diagnosed with diabetes.
Does someone in your family have diabetes? If you are comfortable talking about it, please share your story. We are all in this together.
Source: http://blog.usa.gov/roller/govgab/entry/diabetes_my_family_s_story
Perindopril Side Effect occurred on 2008-11-15
Mucinex Side Effects Poll and Discussion
PatientsVille.com – Latest Comments- Re: Avodart Questions and Answers | Patient Discussion Forum May 18, 2012
- Re: Dulcolax Side Effects May 18, 2012
- Re: Nitrofurantoin Side Effects May 18, 2012
- Re: Avodart Questions and Answers | Patient Discussion Forum May 18, 2012
- Re: Aclasta Side Effects|8 May 18, 2012
- Re: Seretide Side Effects May 18, 2012
- Re: Mersyndol Side Effects May 18, 2012
- Re: Implanon Side Effect Report#3661 itching, redness & swelling May 17, 2012
- Re: Liposit prolib Side Effects Summary - Reports by Liposit prolib Users May 17, 2012
- Re: Lupron Side Effects May 17, 2012
Subscribe to RSS Feed