The consumer advocacy group Public Citizen has petitioned the Food and Drug Administration to pull the popular weight loss drug Meridia from the market.
The group says the drug needs to be yanked immediately because of heart-related risks.
Public Citizen claims 84 heart-related deaths have been reported to the FDA in patients who took Meridia. Thirty of the people who've died were reportedly 50 or younger, and 11 were 30 or younger.
"We would hope that the science behind the results seen in this study would mandate the only appropriate FDA action to protect the public health: immediate removal of Meridia from the market," urges Dr. Sidney Wolfe, who directs the group's Health Research Group.
Drug maker Abbott Laboratories said Thursday that it had not reviewed the Public Citizen petition, but noted that Meridia is only approved for patients with no previous history of cardiovascular disease.
Last month, the FDA said it was "making no conclusions about the preliminary findings" of the 10,000-patient study that showed a slightly higher risk of heart-related problems in patients taking Meridia.
According to a Reuters report, "Meridia's use has decreased in the United States over the past eight years... Still, 294,000 U.S. prescriptions were filled for the drug in the last 12 months..."
Meridia side effects
According to www.drugs.com:
Get emergency medical help if you have any of these signs of an allergic reaction to Meridia: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Meridia and call your doctor at once if you have a serious side effect such as:
--fast or pounding heartbeats
--dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, uneven heartbeats)
--new or worsening shortness of breath
--easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop)
--blood in your urine or stool
--weakness, restless feeling, confusion, anxiety, agitation, fever, overactive reflexes, joint pain, sweating, vomiting, tremors
--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out
Less serious Meridia side effects
--dry mouth, upset stomach
--loss of appetite
--runny or stuffy nose, sore throat, cough
--headache, back pain
--trouble sleeping (insomnia)
--mild skin rash
--changes in your menstrual period
For more information, check out this Associated Press feature http://www.google.com/hostednews/ap/article/ALeqM5hzl0dnRHdMTO6wFTe1D4kG2G-dKQD9CC3S5O0
Author: John McGran