The Food and Drug Administration proposed to amend the labeling regulations on 
over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) 
drug products to include important safety information regarding the potential for 
stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug 
products, commonly known as acetaminophen and nonsteroidal anti-inflammatory 
drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to 
treat pain, fever, headaches, and muscle aches.  Click for Questions and Answers 
on Proposed rule for Labeling Changes to Over-the-Counter Pain Relievers. 

 www.fda.gov/bbs/topics/NEWS/2006/NEW01533.html. 

The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary 
recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 
lots of acetaminophen 500mg caplets manufactured and distributed under various 
store-brands as a result of small metal fragments found in a small number of these 
caplets.  Approximately 11 million bottles containing varying quantities of 
acetaminophen 500mg caplets are affected by this recall. For a list of batches 
affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. 
Consumers can determine if they are in possession of a recalled product by 
locating the batch number printed on the container label. A list of stores that 
carry store-brands potentially affected by this recall is located on FDA's website 
at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

While most prescription drugs marketed in the U.S. have been reviewed and 
approved as required by FDA, some unapproved prescription drugs are marketed by 
companies, prescribed by physicians, and taken by patients. Some unapproved 
drugs, such as phenobarbital, used to control seizures, are very 
important therapies in the treatment of significant medical conditions and appear 
to have benefits for patients, so patients should not stop taking an unapproved 
drug without talking to their doctor first to determine their best treatment options. 
However, being unapproved means a drug’s safety, effectiveness, manufacturing, 
and labeling have not been specifically reviewed by FDA. Click the link above for 
more information on this topic from the U.S. Food and Drug Administration. 

The U.S. Food and Drug Administration (FDA) will continue to provide the public 
with regular updates on the E. coli O157:H7 outbreak each day until further 
notice.  To date, 109 cases of illness due to E. coli infection have been reported 
to the Centers for Disease Control and Prevention (CDC), including 16 cases of 
Hemolytic Uremic Syndrome (HUS) and one death. Illnesses continue to be 
reported to CDC. This is considered to be an ongoing investigation.

Symptoms of Illness
E. coli O157:H7 causes diarrhea, often with bloody stools. Although most healthy 
adults can recover completely within a week, some people can develop a form of 
kidney failure called HUS. HUS is most likely to occur in young children and the 
elderly. The condition can lead to serious kidney damage and even death.  There 
are 19 confirmed states: California, Connecticut, Idaho, Indiana, Kentucky, Maine, 
Michigan, Minnesota, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, 
Utah, Virginia, Washington, Wisconsin, and Wyoming.

Consumer Advice
FDA advises consumers to not eat fresh spinach or fresh spinach-containing 
products until further notice.  If individuals believe they may have experienced 
symptoms of illness after consuming fresh spinach or fresh spinach-containing 
products, FDA recommends that they seek medical advice.

If your doctor told you to take aspirin to help prevent a heart attack, you need
to know that taking ibuprofen at the same time, for pain relief, may interfere 
with the benefits of aspirin for the heart. It is all right to use them together,
but the FDA recommends that you contact your doctor for more information
on the timing of when to take these two medicines, so that both medicines 
can be effective.