Shire expects Adderall XR recall decision reversal

Health Canada's decision to recall Adderall is being met with more resistance from Shire Pharmaceuticals. The company has issued several statements arguing that Health Canada has made a wrong decision. In a statement issued, Shire says:

• Many of the patients on Adderall XR were on it because they had failed other treatments that left them with no treatment at all.
• Abruptly stopping a treatment for ADHD can lead to accidents, expulsion from school, aggression and other serious problems. Untreated ADHD places patients at significant morbidity and mortality that is well established in the literature.
• Many of these patients do not have a family doctor, or their family doctor is not familiar with alternative medication strategies.
• Health Canada assumed that the press release they provided gave doctors sufficient information to explain the risks and benefits of Adderall XR when in reality the press release left physicians completely unprepared to provide their patients with adequate understanding of their relative risks.

The company is arguing that since the FDA has refused to act, Shire must be doing something right, but not many people trust the judgment of FDA. The United States drug regulator not only failed to recall Vioxx, Celebrex, and Bextra on time, in a very bizarre turn of events it constituted a panel to review the safety of this drugs but filled it up with at least 10 doctors who have financial ties to Merck and Pfizer. No wonder, instead of a recall of either of the drugs, the panel recommended that even Vioxx (no longer on the market) be allowed to resume sales and Celebrex and Bextra continue to be sold. (Related article: Validity of FDA panel's recommendations in doubt due to conflicts of interest)

In the meantime, Reuters is quoting Shire CEO Matthew Emmens as saying that they expect that Health Canada will reverse its decision. He is encouraged by FDA's refusal to recall Adderall XR in the United States.

To make its Adderall problems worse, Shire has received a Paragraph IV Notice from Teva Pharmaceuticals USA, Inc., advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of ADDERALL XR. The drug is protected by two patents which expire in 2018. Shire received previously Paragraph IV Notice letters from Barr Laboratories Inc., IMPAX Laboratories Inc. and Colony Pharmaceuticals Inc. relating to their ANDAs for their respective generic versions of ADDERALL XR. As previously announced, Shire has filed lawsuits in response to the Barr and IMPAX ANDA Notice letters.

Related articles:

FDA must recall Adderall XR till complete safety analysis is done

FDA leaves Adderall XR on the market in the US