After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.
To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children...
McNeil Consumer Healthcare expanded its recall to include all product lots of Tylenol Arthritis Pain Caplet, 100 count bottles, with the distinctive red EZ-open cap. In November 2009, McNeil recalled five lots of this product due to reports of an unusual moldy, musty, or mildew-like odor that was related to nausea, stomach pain, vomiting, and diarrhea.
The odor is caused by the presence of a compound believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
The risk: The health effects of the compound believed to cause the symptoms have not been well studied. To date, all of the observed events reported were temporary and not serious.
Recommendations: • Stop using any Tylenol Arthritis Pain Caplet, 100 count bottles, with the distinctive red EZ-open cap.
• Contact the company, McNeil Consumer Healthcare, at 888-222-6036 or at www.tylenol.com, for instructions on how to get a refund or replacement, and how to return or dispose of the product.
Birth Defects Related to Depakote and Similar Drugs
FDA has notified health care professionals and patients about the increased risk of major birth defects in babies exposed to valproate sodium and related products during pregnancy.
The products are marketed under the following brand names:
Depacon (valproate sodium)
Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
Depakene (valproic acid)
Stavzor (valproic acid)
Depending on the products, they may be used to treat epilepsy, bipolar disorder, and migraine headaches.
The risk: There is an increased risk of neural tube defects, such as defects of the brain and spinal cord, and other major birth defects, such as craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels), in babies exposed to valproate sodium and related products during pregnancy.
The medication guide for valproate that is provided with each prescription explains the benefits and risks of valproate and encourages patients to discuss options with their health care professional.