FDA Publishes List of Potential Drug Risks

by: Mike Havrilla

The FDA has published a table with the names of products and potential signals of serious risks and/or new safety information identified for these products during 1Q08 in the AERS database. The FDA notes that patients should not stop taking these medications and should consult their prescriber with any questions as the agency will investigate each of the claims further before taking action or issuing more definitive statements on the reported concerns.

Some highlights from this table of products that are sold by public-traded pharma and biotech companies are listed below in the following format: active ingredient [brand name] - company[ies] - new safety information reported.

  • Duloxetine [Cymbalta] - Eli Lilly (NYSE:LLY) - Urinary retention
  • Heparin - Baxter (NYSE:BAX) & APP Pharma (APPX) - Anaphylactic-type reactions
  • Lapatinib [Tykerb] - GlaxoSmithKline (NYSE:GSK) – Liver toxicity
  • Lenalidomide [Revlimid] - Celgene (NASDAQ:CELG) – skin disease caused by immune system reaction to a variety of drugs, viral infections, or other causes
  • Natalizumab [Tysabri] - Elan (NYSE:ELN) & Biogen (NASDAQ:BIIB) - Skin melanomas
  • Octreotide Acetate Depot [Sandostatin LAR]- Novartis (NYSE:NVS) – Ileus (lack of intestinal movements)
  • Quetiapine [Seroquel] - AstraZeneca (NYSE:AZN) - Overdose due to sample pack labeling confusion 
  • Telbivudine [Tyzeka] - Novartis (NVS) - Peripheral neuropathy 

During trading on Friday, shares of Celgene slipped nearly 2% while Baxter and Eli Lilly lost just over 1% compared to a loss of 0.5% for the Healthcare Sector SPDR (NYSEARCA:XLV). The market value of Elan has decreased by over one-third in the past year while its partner Biogen has shed over one-fourth of its value on renewed concerns of a rare, potentially fatal brain disorder known as PML in multiple sclerosis [MS] patients taking Tysabri. In February 2005, Tysabri was voluntarily removed from the market after two cases of PML were reported.

However, the FDA has recently issued a statement that the labeling will be revised for Tysabri to reflect the new cases, which occurred in patients taking the drug alone rather than previous instances in combination with other MS drugs. Since a risk minimization program for Tysabri is already in place, the FDA announcement relieved investor concerns that the drug would be pulled from the market again.

However, it remains to be seen whether Tysabri can continue to gain market share for MS and expand into other uses, such as the recently launched clinical trial evaluating the drug in the treatment of the blood-based cancer multiple myeloma. Currently, Biogen does not expect to revise the label of Tysabri to reflect the two reported cases of skin cancer in letters to the editor in the New England Journal of Medicine from February 2008.