According to various reports, including a warning from the U.S. Food and Drug Administration (FDA), the prescription drug Aldactone has been found to allegedly cause Stevens Johnson Syndrome (SJS), a painful and potentially deadly skin condition.

The study published on eHealthMe.com gathered data from FDA reports and other sources and found that within a sample of 19,943 Aldactone users, 287 developed SJS. The report, published June 21, also shows that over 62 percent of those who allegedly developed SJS after taking Aldactone were over the age of 60. Of those patients who reportedly developed Aldactone SJS, over 57 percent were male.

In September 2011, the FDA released a formal warning to consumers describing the possibility of having an allergic skin reaction and developing Steven Johnson Syndrome or Toxic Epidermal Necrolysis after taking Aldactone.

Background on Aldactone

Aldactone is a brand name prescription medication of the generic drug spironolactone. It was originally designed, manufactured, and sold by GD Searle LLC and was given FDA approval in January 1960. Currently, it is produced and sold by Pfizer Inc.

The Aldactone drug is used to treat various health conditions, such as high blood pressure. Because spironolactone can also act as a diuretic, Aldactone allows the kidneys to more readily remove water and sodium from a patient’s body. Thus, it is a popular drug used to treat edemas (or swelling) produced by heart, liver and kidney conditions.

Aldactone was also found to be helpful in preventing strokes, heart attacks, various kidney problems and breathing problems. However, doctors and patients should be cautious when prescribing or using Aldactone, as there are several reported side effects that may lead to other health problems, such as SJS.

Other known Aldactone side effects include:

• Numbness
• Muscle pain and/or weakness
• Unusual heart rates
• Drowsiness and lightheadedness
• Trouble urinating
• Shallow breathing
• Nausea and vomiting
• Upset Stomach
• Itching
• Severe skin conditions like SJS

What is Stevens Johnson Syndrome (SJS)?

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are dangerous and painful skin conditions that manifest as allergic reactions to certain types of prescription and over-the-counter medications.

SJS and TEN sufferers experience extreme pain and sensitivity as a result of the topmost layer of skin pulling away from the deeper, more vulnerable layers of skin and the mucous membrane. In severe cases, the mucous membrane may become blistered and infected. SJS victims must be hospitalized for weeks to months at a time to treat the condition and monitor the skin and nerve regrowth. In extreme cases, a patient with SJS may die from the trauma they have sustained.

Some common SJS symptoms include:

• Painful blistering of the skin and mucous membrane
• Flu-like symptoms and high fever
• Sloughing off of skin
• Severe eye conditions such as severe conjunctivis, iritis, palpebral edema, conjunctival and corneal blisters and erosions, and corneal perforation.

Because of this severe and potentially life-threatening reaction, many Adactone consumers may choose to join an SJS class action lawsuit.