Safety-related news and updates for Roche’s cetriaxone (Rocephin) injection; oseltamivir (Tamiflu)  and the follow-up issue about GSK’s rosiglitazone (Avandia).

Rocephin (ceftriaxone) for Inj.– Potential Fatal Interaction with Calcium
Roche and FDA informed healthcare professionals of revisions and changes made to the safety sections of the PI, ie. - CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION - describing the potential risk associated with concomitant use of Rocephin for Injection with calcium or calcium-containing solutions or products. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. In the DOSAGE AND ADMINISTRATION:COMPATIBILITY AND STABILITY section on how ceftriaxone should be reconstituted. Calcium-containing solutions are not among the appropriate solutions described for reconstitution, due to possible incompatibility.

Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone

Dear Healthcare Professional letter can be read from: http://www.fda.gov/medwatch/safety/2007/rocephin_DHCP_june2007.pdf

Safety Concerns About Tamiflu (oseltamivir) Amongst Adolescents 
The Japanese regulatory authorities PMDA has advised against prescribing oseltamivir to adolescents aged 10-19 years. The decision followed the suicides of 2 teenagers while taking the drug. The author also noted more than 100 reports of neuropsychiatric events with oseltamivir in children in Japan, the country with the highest usage of oseltamivir worldwide.

There is little doubt that oseltamivir reduces the number and seriousness of flu; however, the strings of such adverse events called for greater cautions. So far, there has not been causal link proven conclusively, but HCPs are advised to prescribe conservative strategies such as resting, increasing fluid intake, and taking simple analgesics and over the counter symptomatic remedies. In people at higher risk of serious complications the potential benefit of treatment seems greater, although convincing evidence about reductions in hospital admission or mortality is still awaited. In these groups, vaccination still offers a cost effective first line of defence.”

Adapted from BMJ 2007;334:1232-1233

Follow-up on Avandia (rosiglitazone) Safety - ADR Reports Triple
Following the recent analysis linking possible heart risks from the blockbuster diabetes drug Avandia, ADR reporting to US FDA tripled.

The NEJM published the findings on the Internet, reporting that heart attacks, deaths and hospitalizations leaped following the announcement of the possible causality. The sharp rise in heart-related ADRs was solicited by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration.

Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126.  The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.

It also shows the flaws of the safety tracking system which is currently done on voluntary basis. The FDA relies on this voluntary or spontaneous system once a drug is on the market.

British-based GSK PLC insists that the drug is safe and effective. The FDA plans hearings on safety concerns about the drug on July 30. In the meantime, diabetes experts have advised users of the medication to talk to their doctors and not to immediately discontinue it.

Adapted from AP News

**********