Dangerous Drug Gets Another Fda Approval

Dangerous Drug Gets Another Fda Approval

  • Submitted By: NJNJ
  • Date Submitted: 07/02/2009 10:03 PM
  • Category: Science
  • Words: 469
  • Page: 2
  • Views: 442

Abbott Park, IL – In 2005 a 55-year-old man in New Jersey started losing vision in one eye. “I hate getting old”, he thought. He had no idea that his vision loss was a side effect of the eight Humira injections his doctor gave him over the last four months to clear up his arthritis and severe rash.

A year later, scientists at local drug giant Abbott Laboratories conduct a phase 3 clinical trial using the drug Humira to treat Crohn’s disease, a gastrointestinal disease. Abbott announced last week that the FDA approved Humira for treating Crohn’s disease based on that trial. This is the fourth disease that Humira has been FDA approved to treat. The other three are rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, all immune system diseases.

The New Jersey man mentioned at the beginning of this story has not regained his vision but Humira and other similar drugs remain on the market. Researchers showed in 1996 the possibility of vision loss from this class of drugs.

On Abbott’s www.Humira.com website many side effects of Humira are listed, including tuberculosis, cancer, infections and heart failure. Vision loss is not. The website adds, “These are not all the side effects with HUMIRA.”

So who is to blame for such a dangerous drug being so widely available?

A closer look at the many FDA approved drugs shows that at a drug like Humira with many serious side effects is not rare, but normal. Almost every FDA approved drug has a list of possible side effects, but they deem a drug as “safe” if they think the benefits outweigh the risks. And their disclaimer on the www.FDA.gov website is, “You and your health-care provider should decide together if the benefits outweigh the risks for YOU.” But how many of us go over the list of possible side effects with our doctor before getting a new prescription? More likely, the doctor tells us what he or she is prescribing, hands us the prescription and we leave. No discussion....

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