FDA Warnings on Common Drugs

The Food and Drug Administration (FDA) safeguards the nation's supply of food and medications by providing information the public needs to make informed decisions regarding health care and treatment options. The FDA helps protect the public by issuing warnings regarding unsafe drugs. Several drugs commonly found in medicine cabinets carry warnings you should take note of.

Acetaminophen

• Acetaminophen treats pain and reduces fever. Products containing it include over-the-counter Tylenol and prescription drugs such as Vicodin, Lortab and Percocet. To increase public safety, in January 2011 the FDA began asking drug manufacturers to reduce the level of acetaminophen in prescription products to 325 mg. Additionally, new prescription labeling lists potential side effects including severe liver damage and allergic reactions such as itching, rash and difficulty breathing. The FDA warns liver transplant patients and those with liver disease to avoid taking acetaminophen. Patients should avoid taking more than the maximum dosage of 4,000 mg per day and refrain from drinking alcohol with the medication.

Aspirin

• Another common household drug is aspirin, a salicylate used to reduce pain, fever and inflammation and used as part of a regimen to reduce strokes and heart attacks. FDA cautions against its use in conjunction with ibuprofen, which interferes with aspirin's blood-clotting properties. Patients should space ibuprofen dosage at least 30 minutes after aspirin intake. Aspirin should not be given to children with the flu or chickenpox because it can lead to Reye's syndrome and even death. People with bleeding ulcers or hemophilia need to avoid aspirin. Pregnant women should not take aspirin because it can damage the fetus' heart or cause other birth defects.

Diphenhydramine

• Many people use diphenhydramine, found in medicines such as Benadryl, to help relieve their allergy symptoms. It is available in an oral form and a topical form for skin allergies. In May 2010, the FDA issued warnings to consumers to avoid ingesting the topical form of diphenhydramine because it yields a dangerously high dose. In some cases, individuals took more than 50 times the recommended dose. Because the oral and topical forms are similar in appearance, the FDA warns to use caution to avoid confusing the two. The manufacturer of Benadryl has since updated labeling on the topical form to indicate the product is for skin use only; the FDA has urged other makers of diphenydramine to follow suit.

Naproxen

• Naproxen, a nonsteroidal anti-inflammatory drug, is used to treat arthritis and ankylosing spondylitis. It comes in both over-the-counter and prescription forms. Prescription versions include Naprosyn and Anaprox and over-the-counter versions include Aleve. Its use can cause life-threatening stomach bleeding and ulcers. Long-term use, drinking alcohol and smoking increase these risks. The FDA also warns against increased risk of stroke and heart attack from the use of naproxen and other NSAIDs.