FDA Orders Stronger Label Warnings On Products
To make known the risks of these products, the FDA ordered the makers of 13 sedative-hypnotic drug products to strengthen warnings on their labels about two rare but serious side effects: allergic reactions and complex sleep-related behaviors.
The revised labeling and other actions to make risks known affect these sedative-hypnotic products:
- Ambien, Ambien CR (zolpidem tartrate)
- Butisol sodium
- Carbrital (pentobarbital and carbromal)
- Dalmane (flurazepam hydrochloride)
- Doral (quazepam)
- Halcion (triazolam)
- Lunesta (eszopiclone)
- Placidyl (ethchlorvynol)
- Prosom (estazolam)
- Restoril (temazepam)
- Rozerem (ramelteon)
- Seconal (secobarbital sodium)
- Sonata (zaleplon)
In addition to the labeling changes, FDA has requested that manufacturers of sedative-hypnotic products:
- send letters to health care providers to notify them about the new warnings. (Manufacturers sent these letters beginning in March 2007.)
- develop Patient Medication Guides for the products to inform consumers about risks and advise them of precautions that can be taken. (Patient Medication Guides are handouts given to patients, families, and caregivers when a medicine is dispensed. The guides will contain FDA-approved information, such as proper use and the recommendation to avoid ingesting alcohol or other central nervous system depressants.)
- conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.
Related Links:
http://usgovinfo.about.com/b/2007/03/15/fda-calls-for-stronger-warnings-on-sleep-drugs.htm
http://fmsglobalnews.wordpress.com/2007/03/14/fda-requests-label-change-for-all-sleep-disorder-drug-products
Resources:
U.S. Department of Health and Human Services. U.S. Food and Drug Administration. (2009, July 22). Side effects of Sleep Drugs Retrieved on 1st October, 2009 from
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107757.htm
U.S. Department of Health and Human Services. U.S. Food and Drug Administration. (2009, October 27) Sleep Disorder (Sedative-Hypnotic) Drug information Retrieved on 29th October, 2009 from
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm
Tried Lunesta for a while. It leaves a very metallic taste in your mouth for most of the next day. Not a fan at all....
ReplyDeletewell, its about time they started doing something about these meds...
ReplyDeletenow, hopefully consumers take the time to read through these guides...
WHY NOW? why did it take so long to do something? during the drug study before a medication becomes prescribeable weren't there any case studies noted that certain side effected occur? I don't understand the FDA are they here to protect us or just driven by the pharmaceutical companies and have no control.
ReplyDeleteSANDRA said...
ReplyDeleteMore and more consumer reports and complaints are being made about complex sleep behaviors occuring as a side effect, so that is why the FDA is enforcing labeling and warning changes. Apparently when ambein was first submitted in 1992 for approval by the FDA. The Ambien clinical studies included 111 subjects (76 males and 35 females). Thirty of the subjects were documented as experiencing amnesia, and 10 had hallucinations. They documented that virtually all reports of amnesia/hallucinations occurring at recommended doses appear to be explainable in terms of the patient's life situation, rather than as possible pharmacologic effects of Ambien. Events were usually mild/moderate in intensity, lasted no more than a few hours, and left no residuals. In their report they recommended labeling should reflect the single instances of memory impairment and depression which were reported at 10mg doses and were not otherwise explainable.
The FDA states the following response on why they would approve a drug if it has risks. All drugs approved for sale in the United States by FDA must prove that they have beneficial effects on the body by curing disease, controlling disease, preventing disease or relieving symptoms. But all drugs also have side effects or risks: most are minor; some can be serious or rarely even life-threatening. FDA’s job is to balance a drug’s benefits against the risks for the drug’s intended use. The agency approves a drug only after determining that the benefits outweigh the risks for most people, most of the time.
Why do some safety issues arise after a drug has already been approved for marketing? The FDA answered with the following: We are always learning new information about a drug once it has been approved for sale and is in general use. Common side effects or risks of a drug are usually clear when a drug is approved. But clinical trials, don’t reveal all of the risks. A rare problem may only come to light after the drug is used in millions of people in the larger population. The fact that we commonly observe new or more frequent side effects is why FDA continues to evaluate drugs after they are approved. Post-marketing surveillance is one way to monitor a drug’s safety on an ongoing basis. After a drug is approved, long-term safety studies and additional clinical trials also may be conducted and evaluated.
The FDA then looks at all the evidence available and asks: Do the benefits of this drug still outweigh the risks? It seems that in their view the benefits are still greater than these strange and dangerous reported effects. In many cases, new information about side effects is added to the drug’s labeling. FDA also may ask the drug company to develop a Medication Guide—a handout given to patients, families, and caregivers when a medicine is dispensed. These guides emphasize drug risks and advise patients on avoiding problems.
From what I gather the FDA does not consider complex sleep behaviors induced by the hypnotic/sedatives sleep medications to pose serious and life-threatening risks, such as kidney, liver or heart damage. So that is why they still remain on the market today.
Below are the web pages regarding FDA Managing Drug Safety Issues and the Ambien Approval Documentation.
FDA Label and Approval History:
http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfmfuseaction=Search.Label_ApprovalHistory#apphist
FDA Consumer Health Information:
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107850.pdf