Health and Wellness

FDA Advisories in 2004m

FDA-issued warnings have been in the news, informing physicians and consumers about possible drug risks. To follow is a brief overview of some of the advisories in 2004.

In January 2004, the FDA launched a consumer educational campaign regarding the safe use of over-the-counter (OTC) pain products and fever reducers. These include acetaminophen and non-steriodal anti-inflammatory drugs (NSAIDs), which include aspirin, ibuprofen, naproxen sodium, and ketoprofen.

The FDA wants consumers to read labels carefully and check with their physician or pharmacist to ensure proper dose, minimizing the risk of an accidental overdose. For instance, acetaminophen is found in more than 600 OTC and prescription medications (such as pain relievers, cough suppressants, and cold medications). Used correctly, this medication is safe, but too much can lead to liver damage, particularly when combined with alcohol. NSAIDs can cause stomach bleeding for some, as well as an increased risk of kidney problems.

In March 2004, the FDA recommended close observation of patients for worsening depression or the emergence of suicidal thoughts when treated with antidepressant medications. While these medications can be extremely beneficial, physicians and patients need to be aware of this potential danger.

In June 2004, the FDA issued a public health advisory for Crestor®, a drug used for lowering cholesterol. Doctors were cautioned to follow dosing instructions closely due to reports of serious toxicity (including a muscle-destroying disease and fatal kidney damage) in some patients.

In September 2004, the FDA issued an advisory as Merck & Co. voluntarily withdrew its product Vioxx® from the market because studies suggested an increased risk of serious cardiovascular (CV) events, including heart attack or stroke.

In December 2004, the FDA announced that a clinical trial using larger doses of Celebrex® was stopped due to the increased risk of CV events. Bextra® has also shown a greater risk for CV events in patients following heart surgery. Additionally, preliminary trial results suggest that long-term use (three or more years) of naproxen may also be associated with an increased risk of CV events.

Please note that the only drug to be taken off the market is Vioxx, and this was done voluntarily by the drug company. No one should make a change to his or her treatment regimen without a doctoríƒÙs approval, and anyone concerned about these advisories should speak with a doctor or pharmacist. Several of these drugs can be taken safely at proper doses, so closely following the doctoríƒÙs instructions (and OTC drug labels) is crucial. Consumers may keep apprised of FDA warnings and recalls by going to www.fda.gov or by calling the FDA information line at (888) 463-6332.