admin January 18th, 2008
The FDA have issued warnings about the potential confusion between edetate disodium instead of edetate calcium disodium, and the unlicenced use of edetate disodium for chelation therapy.
There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for “chelation therapies” and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.
Further information.
Q&A.
admin January 8th, 2008
The MHRA have published the January edition of Drug Safety Update. This month’s edition contains:
- Statins: interactions, and updated advice for atorvastatin
- Methylthioninium chloride (methylene blue): CNS toxicity with serotonergic drugs
- Desmomelt (desmopressin): call for Yellow Card reporting
- Bivalirudin: risks associated with incorrect dose
- Yellow Card scheme update: What happens to Yellow Card data?
- Hot topic: Long-acting β2 agonists for asthma: review
- Carisoprodol: recommendation to suspend Marketing Authorisations
- Paraffin-based skin treatments: risk of fire hazard
- Oral anticancer medicines: risk of incorrect dosing
- Other information from the MHRA: Patient Information Leaflet of the month
admin January 8th, 2008
The FDA have issued advice about bisphosphonates and severe musculoskeletal pain.
The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.
This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.
Bottom line: Patients who present with severe musculoskeletal pain who are taking bisphophonates may benefit from a temporary or permanent cessation of therapy.
admin January 8th, 2008
The West Midlands Centre for Adverse Drug Reactions wishes all of our readers a Happy New Year. We hope you have a prosperous 2008, and don’t forget to report any adverse drug reactions you come across.