We Point Out One FDA Information Site and One FDA Database, Each of Which Are Good Starting Points

 

(Posted by Tom Lamb at Drug Injury Watch)

 

If you or someone you know experienced serious side effects that may have been caused by an FDA-approved prescription medicine, for various reasons you may want to do some drug injury research.

In order to make sure that you are using credible sources, we point out two FDA resources online — an information site and a database that is searchable — which are good starting points for your drug injury research.

(1) Drug Safety Communications

This webpage was developed to provide the public with easy access to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories issued prior to January 29th, 2010. You can also find drug specific information using the Index to Drug-Specific Information.

( 2) Drug Safety-related Labeling Changes (SrLC)

The Drug Safety-related Labeling Changes (SrLC) database provides approved safety-related labeling changes from January 2016 forward. Data prior to January 2016 will continue to be available on the MedWatch website.

For more explanation about this second FDA resource and some guidance about its database, we refer you to another FDA webpage, “Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug Labeling“, from which we get these excerpts:

The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in labeling for human prescription drugs regulated under NDAs and human prescription biological products regulated under BLAs. Updates are available since January 2016….

This database has two searches: A Search Labeling by Drug Name, and a Search Labeling by Date Range

This website provides these safety information to the public, including health care vendors who integrate these important prescription drug labeling updates into systems frequently accessed by health care practitioners and/or patients. Ultimately, the FDA expects that prompt access to these vital new safety data by health care practitioners and patients will better promote patient health.

This SrLC database was renamed to clarify to users that the data from these labeling searches include SLCs that were required by FDA as well as updates to safety information in the labeling recommended by the FDA or initiated by companies….

This database also does not include safety information from approved Prescribing Information under original NDAs and BLAs (see Drugs@FDA) or safety data prior to January 2016. Data prior to January 2016 are available on the MedWatch website.

Our law firm has been representing patients and their families in drug injury lawsuits for the past 23 years. If our firm might be of assistance, we encourage you to submit a Drug Injury Case Evaluation Form –- it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak with us about a possible drug injury legal compensation case.

In closing, we want to emphasize this important fact: Patients should not stop taking any prescription drug without seeking the advice of their medical doctor.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation – Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)