NATIONAL SPOKESPERSON July 21, 2008 Suzanne Rogers

CHAIRPERSON Samuel A. Schulhof IMMEDIATE PAST CHAIR MGFA Chapter Leaders - Esther M. Land VICE CHAIRPERSON We wanted to give MGFA Chapters information regarding our communication Ron McFarlane, R.Ph

ACTING SECRETARY with Impax Laboratories in regard to the issue of pyridostigmine tablets. On behalf Marie T. Ronnlof of MGFA’s Medical/Scientific Advisory Board, I contacted Gerard Cravello from TREASURER Marc Kalish, JD Impax to report that a number of patients have noted that pyridostigmine tablets

LIAISON OFFICER from Impax have been crumbling or disintegrating on exposure to air. The Marie T. Ronnlof following is Mr. Cravello’s response on May 13, 2008. MEDICAL/SCIENTIFIC ADVISORY BOARD REPRESENTATIVES Dear Dr. Baron, Richard J. Barohn, MD Henry J. Kaminski, MD Let me respond to your inquiry on complaints for soft tablets experienced by NURSES ADVISORY BOARD patients. There is also an advisement on the MGFA website alerting MG patients REPRESENTATIVES of this issue on the generic Mestinon (pyridostigmine) from the manufacturer, Wilma Koopman, RN, MScN Impax Laboratories (distributed by Global Pharmaceuticals).

DIRECTORS The website states that the complaints involve disintegration and decreased Steven J. Hawco potency of the tablets. We have received complaints for soft tablets which are Susan Klinger Michael D. Klingman referred to as a disintegration issue on the website. I would mention that for all Nancy Law complaints received, either from pharmacies or patients, we perform a thorough Marcia S. Lorimer, RN, MSN, documented investigation. With few exceptions all soft tablet complaints are due CPNP Janet Myder, MPA to patients transferring tablets from the pharmacy vial to a pillbox. Impax Louis Nemtsov recommends that dispensed medication be kept in the original container and not Robert L. Ruff, MD, PhD be transferred to secondary containers such as pillboxes. The product has a Michael J. Rusinko tendency to absorb moisture if not properly protected. The pillbox does not CHIEF EXECUTIVE provide the security required to prevent moisture pickup; prolonged tablet Janet Golden exposure to the open environment or other inappropriate patient handling may also PRO BONO COUNSEL contribute to soft tablets. Current labeling on the Global bottle states: Oppenheimer, Wolff, and Donnelly, LLP “These tablets are hygroscopic. Keep in a dry place with the silica gel enclosed. MG is an autoimmune neuromuscular disorder. Caution: Extremely moisture sensitive. Do not remove desiccant. Close tightly.”

Impax Laboratories is reviewing a number of different areas to limit and attempt to prevent field complaints for soft tablets. We are looking at a more prominent Symptoms may include: display to the pharmacist and patient of the moisture sensitive nature of the  double vision product and the importance of storing the product with desiccant.

 drooping eyelids With respect to the MGFA statement of “decreased potency of the tablets”, this is  slurred speech not accurate based on the data that Impax has accumulated (a) from laboratory tests conducted on complaint samples, and (b) from tablets tested from random  difficulty chewing and swallowing commercial lots as part of our ongoing stability program to satisfy internal

 weakness in arms and/or legs compliance and FDA guidelines. In both cases, potency results meet predetermined specifications up to the shelf life of the product. National Office  1821 University Ave W, Ste S256  St. Paul, MN 55104-2897  Phone: (800) 541-5454  (651) 917-6256 Please contact me as required if further information or clarification is required.

Regards, Gerard D. Cravello

I then asked if we could pass this information on to MGFA Chapters, and his response on July 1, 2008, follows below.

Hi Dr. Barohn,

At this time, the advice to patients is that the tablets they receive in either the Global bottle or the pharmacy vial are not to be transferred to a pill box. Removing the tablets from the Global bottle or vial and storing in another container configuration compromises the tablet quality. The tablets are moisture sensitive (hygroscopic) and must be kept in a dry place.

Impax is recommending additional cautionary statements on label materials to advise patients of the special handling requirements. Also, we are reviewing our manufacturing process stages for the product as a means to improve the product’s robustness.

Once our review is concluded, I will be sure to inform you and provide you with further details.

Regards, Gerard D. Cravello

Thank you.

Richard J. Barohn, MD Chair, Medical/Scientific Advisory Board Department of Neurology University of Kansas Medical Center