FDA about Meridia

The weight-loss pill Meridia (Reductil in Europe) has been a huge sales success for Abbott Laboratories, which asserts that the drug has been sold to millions of people in 65 countries. Meridia, generic sibutramine, was approved by the FDA for Knoll Laboratories in 1997. Abbott Laboratories got Knoll in 2001.

Clinical studies show that Meridia (Reductil) can help people lose a little weight - about six and a half pounds at the standard dose - after a year's use. During a second year of use, most people regain some of this weight, but not as much as people who don't take the drug. These studies also show that the drug increases blood pressure. It's a small increase, but any increase in blood pressure can be bad news for an obese person. And a few patients have a very serious increase in blood pressure.

Public Citizen, which initially petitioned the FDA about Meridia (Reductil), supplemented its effort with new information from the FDA "adverse event" database. FDA spokeswoman Laura Bradbard said that after the initial Public Citizen petition, the agency began an additional review comparing adverse event reports for Meridia and for Xenical, another major weight-loss drug that doesn't have amphetamine-like components.

Dry mouth, sleeplessness, irritability, back pain, stomach upset or constipation may occur the first few days as you body adjusts to the medication. Stop MERIDIA if you experience rash, hives, seizures, worsening of vision, decreased amount of urine or unusual bleeding or bruising.

Currently, Generic Meridia is one of only two pharmacologic options for long-term (up to 2 years) weight management approved by both the FDA and the European regulatory agencies. An individual cannot take Meridia if he or she is taking a prescription medicine that falls in a group of drugs called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. If you have taken Meridia, and have any concerns regarding any of the above, you should contact a physician immediately.

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