Three of the Top Ten Drugs Forecast for 2014 may be Subject to Safety Lawsuits
On April 13, 2010 Reuters published a sales forecast predicting the ten top selling drugs for 2014. Contained on that blockbuster list are three drugs, Advair, Remicade and Crestor, which have drawn the scrutiny of consumer safety monitors and attorneys representing injured patients.
Consensus of sales forecasts for world's top 10 drugs in 2014:
- Avastin (cancer) Roche $8.9 bln
- Humira (arthritis) Abbott (ABT.N) $8.5 bln
- Enbrel (arthritis) Pfizer(PFE.N)/Amgen(AMGN.O) $8.0 bln
- Crestor (cholesterol) AstraZeneca (AZN.L) $7.7 bln
- Remicade (arthritis) Merck(MRK.N)/J&J(JNJ.N) $7.6 bln
- Rituxan (cancer) Roche $7.4 bln
- Lantus (diabetes) Sanofi-Aventis (SASY.PA) $7.1 bln
- Advair (asthma/COPD) GlaxoSmithKline (GSK.L) $6.8 bln
- Herceptin (cancer) Roche $6.4 bln
- NovoLog (diabetes) Novo Nordisk (NOVOb.CO) $5.7 bln
Advair, an inhaler used to treat asthma has been found to increase the likelihood of death among children. On November 28, 2007, a Food and Drug Administration (FDA) advisory panel recommended that GlaxoSmithKline (GSK) add more language about the risks to children. on February 18, 2010 the FDA published new safety requirements aimed at restricting or limiting the use of Advair and other drugs in its class. This was in response to results received from the Salmeterol Multi-center Asthma Research Trial (SMART), the Salmeterol Nationwide Surveillance study (SNS), and a meta-analysis conducted by FDA in 2008 and discussed at the joint Pulmonary Allergy Drugs, Drug Safety and Risk Management, and Pediatric Advisory Committees, held on December 10-11, 2008 (for complete safety reviews and background information discussed at this meeting see the following link: December 10-11 2008 AC meeting. The SMART Study found increased relative risk (RR) of 4.37 (1.25, 15.34) among users of the drugs as opposed to those taking a placebo.
The more startling finding was an increased relative risk (RR) of 14.83 (3.24, 26.43) for children to suffer an event defined as asthma-related death, intubation, and hospitalization compared to children not taking the drug. This means that children who are Advair users are almost 15 times more likely to suffer death, intubation or hospitalization then those who do not take Advair. Lawsuits alleging that Advair caused the death or serious injury of patients including young children have been filed against GSK and are pending primarily in Philadelphia.
Remicade which is in the same class of drugs as Humira and Enbrel, known as TNF inhibitors, is used to treat rheumatoid arthritis. Since their entry into the market the FDA has issued a series of heightened warnings. On September 4, 2008 the FDA ordered a strengthening of the warning for all drugs in this class informing physicians of the increased risk of fungal infections that could lead to death if not properly treated. In November, 2009 the FDA ordered that the label be changed once again to include a boxed warning for Malignancy, to advise that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade. Further the warnings section is to include a warning that "cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications."
The cholesterol fighting drug Crestor has recently come under scrutiny after a study published in Lancet reported an increased risk for the development of diabetes among users. This comes at a time when AstraZeneca the manufacturer of Crestor has successfully sought new approved uses for the drug to expand its potential market outside of the treatment of high cholesterol.
