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Popular Allergy Drug Under FDA Inspection

Singulair is a very popular medication prescribed for allergies; it is used with much success for both typical allergy reactions and in preventing asthma attacks. As such, it is a medication that both physicians and patients have been pleased to have available.

Unfortunately the old saying of when something seems too good to be true, it probably is, may also hold true with Singulair. There is a possible link between Singulair and suicide ideation as well as mood swings, anxiety and depression. Merck, the manufacturer of Singulair, points out that these are reactions received by report only and have not been observed in clinical testing.

”We have no indication that anything about the mechanism of Singulair is consistent with these events,” said George Philip, Director of Research and Product Development, Merck & Co, Inc. ”But because suicide is a life-threatening event we thought it was important to provide this information in the product label.”

Further information can be found at the link below. It is important that patients not discontinue Singulair suddenly without a physician’s guidance. Patients on Singulair who are concerned about these side effects should talk with their medical care provider as soon as possible.

FDA Early Communication Report on Singulair

FDA Investigates Merck Drug - Suicide Link

FDA Concerned: Suicide Ideation with Seizure Drugs

The FDA has released information that patients taking medications for epilepsy, bipolar depression and some mood disorders, are experiencing an increase in suicidal thoughts. The risks are not insubstantial either; the FDA states that risk is doubled. Physicians however believe that the benefits of these medications outweigh the risks.

    The drugs of concern include:

  • Depakote
  • Lamictal
  • Topamax
  • Keppra
  • Lyrica
  • Neurontin

Interestingly enough, very recently the FDA approved the medication Lyrica for the treatment of fibromyalgia. It does indeed raise the question of what does it mean to have the risks outweigh the benefits.

The FDA will be meeting with various drug companies to discuss warning labels that will be placed on these medications. It is unclear as to what these warnings will say as the risk seems to be greater for the anticonvulsant medications than those used for psychiatric purposes. And the problem is only made more complex when it is realized that all of the medical conditions that these drugs are prescribed for, are difficult to treat. A patient may only have one of two options. Then of course “risk vs benefit” becomes a very personal issue.

“The consequences of seizures are dire,” Dr. Cynthia Harden, a professor of neurology at Weill Cornell Medical College said. “There’s a risk of injury, even brain injury from a prolonged seizure, a loss of awareness and tremendous anxiety as these episodes can come without warning. It’s a very difficult illness to live with, and these drugs are well worth trying.”

The New York Times

Hopefully in time, research can find ways to treat these disorders and simultaneously avoid side effects. The vagus nerve stimulation treatment is one option that is showing very promising results for people with seizure disorders. Cognitive therapy can be helpful for those with mood disorders.

But unfortunately at this time we are left with disorders and medications that produce potentially deadly side effects. Answers do not come easily to such problems.

FDA Alerts Healthcare Providers 

Vagus Nerve Stimulation

FDA Approves Lyrica for Fibromyalgia

Resources

  • RECALL ALERTS

    "Total Body Formula" and "Total Body Mega Formula"
    The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
    More Information

    Canteloupe

    The current list of recalls in canteloupe is quite extensive and covers many brands and locations. If you purchase canteloupe in any form (cut, sliced, whole) you need to check the various announcements. The concern is about salmonella.

    Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Symptoms of food-borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.

    Canteloupe Recall Information
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