Allergic Reactions Very Often Tied to Adverse Drug Event Reports

Allergic_Reactions_Tied_to_Adverse_Drug_Event_ReportsA review of a year’s of adverse drug reactions reported to the U.S. Food and Drug Administration (FDA) revealed that drug allergies were the second most commonly reported reaction, overall.

Reports from April 2012 to March 2013 were reviewed and involved almost 150,000 cases. Philly.com’s review, which it shared with medical professionals, found that of the cases reported, drug allergies were the second most popularly reported adverse events. Of these, about 4,000 were deemed severe; 3,079 involved a medical emergency or a disability and 966 involved death. Some 234 different drugs were involved and were associated with four key reactions.

The first category of allergic reactions involved the sometimes deadly anaphylactic shock, which may involve emergency treatment and may involve breathing reactions and a drop in blood pressure that falls to dangerous levels, according to Philly.com. Anaphylactic shock occurs in seconds or minutes following exposure to an allergen such as a bee sting or peanuts, or, in these cases, a medication. If not immediately treated, anaphylactic shock may lead to death and accounted for about 30 percent of the cases deemed severe hypersensitivity cases and 133 of the deaths.

A total of 44 medications were associated with at least 10 cases of anaphylaxis, with Xolair (omalizumab) accounting for the most reports. Xolair is an injectable biologic used in the treatment of asthma or chronic hives and is administered by a doctor. The other drugs Philly.com noted that led to anaphylaxis included non-steroidal anti-inflammatory drugs (NSAIDs) such as Motrin and Advil (ibuprofen) and Aleve and Naprosyn (naproxen), the blood pressure drug Norvasc (amlodipine), and Zestril and Prinivil (lisinopril).

Skin eruptions were also seen as a common drug side effects, some mild, but some of the drugs triggered more potentially life-threatening skin reactions, including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN), which are potentially deadly and similar to severe burn cases. During the study period, Philly.com identified 891 potential cases of severe cutaneous reactions, which comprised about 22 percent of all of the severe hypersensitivity cases, including 97 deaths and 35 cases of permanent disability.

The most commonly identified drug that led to the most significant cutaneous reactions was Incivek (telaprevir), an antiviral agent used with two other antivirals in the treatment of chronic hepatitis C. Philly.com identified 131 cases of severe hypersensitivity with this drug, including 14 fatalities and 105 cases of severe reactions, which is more than any other drug in the media outlet’s review. In fact, according to the Infectious Diseases Society of America, Incivek is “markedly inferior to preferred and alternative regimens” over its being “associated with higher rates of serious adverse events.” Other drugs commonly associated with severe skin reactions included Lamictal (lamotrigine), allopurinaol, Cymbalta (duloxetine), vancomycin, Bactrim (sulfamethoxazole/trimethoprim), Dilantin (phenytoin), and Cleocin (clindamycin).

Angioedema, which is a common reaction typically caused by drugs, foods, and insect bites and which carries a lifetime risk of 15-25 percent in the general population. Reactions include hive-like swelling under the skin around the eyes and lips and, sometimes, involving mucous swelling of membranes, as well as breathing difficulties. Angioedema may be life-threatening if it occurs in the upper airway and blocks breathing. The research revealed 891 cases of severe angioedema associated with linisopril, when given alone and with the diuretic, hydrochlorothiazide. Vasotec (enalapril) and three antibiotics in the class known as the fluoroquinolones—Levaquin (levofloxacin), Avelox (moxifloxacin), and Cipro (ciprofloxacin)—were commonly tied to this reaction; linisopril and Avelox were also tied to cases of anaphylactic shock.

The last category involved atypical reactions that did not fit in the other categories and five out of 10 of the most frequently reported drugs were newer biological products used in the treatment of conditions that include cancer. Tarceva (erlotinib) was associated with more serious hypersensitivity than the other drugs and is used in the treatment of pancreatic cancer and one type of lung cancer in which long-term survival is rare; reports of rash and deaths (461) were numerous, according to Philly.com.

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