Bad reactions to a medication get reported to the FDA through MedWatch. When the FDA analyzes all the serious drug side effects in that database, it issues periodic reports. The agency thinks it has done its job by alerting health professionals and the public to these potential hazards. Unfortunately, these alerts may disappear almost without a trace within days. Busy physicians and pharmacists might never even see the list of medicines that worry the FDA. And patients often don’t even know where to look to see these warnings.
Today’s People’s Pharmacy Alert is intended to make you aware of some of these potential dangers.
• Cetirizine (Zyrtec) is an over-the-counter antihistamine that is promoted for allergy symptoms and congestion. The FDA has discovered that the drug may cause an unusual adverse reaction called “oculogyric crisis.” This peculiar and frightening reaction is characterized by an uncontrollable fixation of the eyeballs in an upward direction. The eyes may also cross or even look down. The eyes hurt and it is hard to manage their movement voluntarily. Other symptoms may include anxiety, agitation, dizziness, jaw spasm, blinking, opening the mouth and sticking out the tongue.
Something the FDA has not warned about, as far as we know, is withdrawal from cetirizine. Many visitors to this website have reported they experience unbearable itching for several days or weeks if they stop taking the drug suddenly. You can find vivid descriptions of this reaction by clicking on this link.
• Docetaxel (Taxotere) is used to treat a wide range of cancers including breast, lung, prostate, head, neck and stomach. New information suggests that it interacts in a potentially deadly way with the heart rhythm drug dronedarone (Multaq).
• Fluoroquinolone antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox) and norfloxacin (Noroxin) are used for a wide range of infections including bronchitis, pneumonia, sinusitis, urinary tract infections, prostatitis and skin infections. The FDA has received reports of retinal detachment with these antibiotics. Problems with tendinitis and tendon rupture are so serious that the FDA has warned doctors about them in a special “black box” in the prescribing information. It took the agency quite a long time to discover this devastating complication.
• Olmesartan (Benicar) is a popular blood pressure medication. The FDA has become aware that this drug can cause severe diarrhea that may interfere with proper nutrient absorption. Patients who experience digestive distress and weight loss should bring this new warning to their doctors’ attention.
• Proton Pump Inhibitors (PPIs) are powerful acid-suppressing drugs prescribed for serious heartburn or GERD (gastroesophageal reflux disease). They include
• Esomeprazole (Nexium)
• Lansoprazole (Prevacid)
• Omeprazole (Prilosec)
• Pantoprazole (Protonix)
• Rabeprazole (Aciphex)
The FDA is catching up with what has been reported in the medical literature for several years, namely that these drugs can increase the risk for pneumonia. That may be because reducing acid in the stomach may create an environment conducive to bacterial growth. These germs may be able to migrate to the lungs and cause a great deal of mischief. Other infections associated with this class of medications include C. diff, a very hard to treat bacterial overgrowth of the intestines that causes potentially life-threatening diarrhea. See the accompanying People’s Pharmacy Alert for a novel way to deal with these hard-to-treat infections. It can also be challenging to get off PPI-type drugs. Here is a link that describes the challenge and some strategies that may help.
It can take the FDA years to discover some of these serious complications from medications. We continue to do our best to alert you to such adverse reactions as soon as we learn about them, frequently years before the agency is ready to take official action.
