If you want to stay up-to-date on medication and medical device safety alerts, get the news straight from the source you use to report adverse drug events -- MedWatch. Now you can sign up to have the FDA's safety information and adverse event reporting program deliver timely notifications to your e-mailbox.
Visit "MedWatch E-list" to learn more about the service, including how to subscribe. As a subscriber, you'll receive brief recaps of recent FDA safety alerts and public advisories involving drugs and other medical products, along with links to sources for further information.
Here are some examples of recent actions included in MedWatch's safety summaries list:
- The FDA updated health care professional and patient information sheets on antidepressants following a June 30 Public Health Advisory about the increased risk of suicidality among adults being treated with certain antidepressant medications.
- The agency updated package labeling for tadalafil (Cialis), vardenafil (Levitra) and sildenafil (Viagra) in the wake of a small number of reports of sudden vision loss among patients taking the drugs. The vision problems have been attributed to nonarteritic ischemic optic neuropathy, in which blood flow to the optic nerve is blocked. Whether these medications for erectile dysfunction caused the vision losses remains unclear.
- On July 13, the FDA asked the maker of an extended-release formula of hydromorphone, sold as Palladone in the United States, to withdraw the drug from the market. The move was precipitated by new information that potentially fatal adverse reactions can occur when the capsules are taken with alcohol. Data from a manufacturer-sponsored study found that combining the drug with alcohol could lead to "dose-dumping," or rapid release of the active ingredient in the once-a-day pain medication.
- The agency issued a Public Health Advisory on July 15 after reports of deaths among patients using transdermal fentanyl, sold generically or under the brand name Duragesic. FDA officials are investigating the deaths to determine whether they are due to inappropriate use of the pain-relief patches or to quality problems with the product. In the meantime, the agency has released information sheets for health care professionals and patients detailing safety precautions for those using the drug.
- On July 19, the FDA issued an advisory informing health care professionals and patients about four cases of fatal sepsis in women who had undergone medical abortion with mifepristone (Mifeprex) and misoprostol. Bacteria thought to be responsible for two of the deaths have been identified; the other two cases remain under investigation by FDA and CDC officials.
