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To: RxLink

From: Janssen Pharmaceutica

October 19, 2004

Important Safety Alert Regarding Medication Errors

Janssen Pharmaceutica Products, L.P. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. have recently been made aware of several reports of medication errors involving confusion between Reminyl (galantamine hydrobromide), a drug approved for the treatment of mild to moderate dementia of the Alzheimer's type, and Amaryl (glimepiride), a product of Aventis Pharmaceuticals Inc., indicated for the treatment of non-insulin dependent (Type 2) diabetes mellitus. These reports include instances in which Reminyl was prescribed but Amaryl was incorrectly dispensed and administered instead, leading to various events including severe hypoglycemia and one death.

According to spontaneous reports submitted to the FDA and the United States Pharmacopoeia, prescriptions have been incorrectly written, interpreted, labeled, and/or filled due to the similarity in names between Reminyl and Amaryl. These two products have an overlapping strength (4 mg) and an overlapping dosage form (tablets). In addition, both products have generic names (galantamine vs. Glimepiride) that might lead to their storage in close proximity.

It is important to note that Reminyl has a starting dosage of 4 mg TWICE a day, whereas Amaryl is initially dosed at 1-2 mg ONCE a day, with a maximum starting dosage of 2 mg.

Reminyl is supplied for oral administration as 4 mg (round, off-white), 8 mg (round, pink), and 12 mg (round, orange-brown) tablets. Reminyl tablets are imprinted "Janssen" on one side, and 'G" and the strength "4", "8", or "12" on the other side.

Amaryl is applied for oral administration as 1 mg (pink, flat-faced, oblong with notched sides at double bisect and imprinted with "Amaryl"), 2mg (green, flat-faced, oblong with notched sides at double bisect and imprinted with "Amaryl") and 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with "Amaryl").

We recognize that medication errors have multiple system causes and the pharmacist's role in avoiding such errors is pivotal. Your assistance and increased attention is requested in verifying and accurately dispensing oral and written p[prescriptions for these two products to help avoid future medication error.

We offer the following suggestions to help decrease the potential for future errors:

-Place Amaryl and Reminyl apart from one another on the shelf; we advise use of the enclosed "shelf talker" described below

-Confirm the brand name prescribed on written and oral prescriptions

-Counsel patients about the brand name, indication and proper use of each medication.

Janssen Pharmaceutica Products, L.P. has developed the following enclosed material for pharmacists to help prevent further medication error.

- A 'shelf talker" that can be used to help differentiate Reminyl form other stocked merchandise.

If you become aware of any medication errors involving Reminyl, report them immediately to us at 1-800-JANSSEN (526-7736), and if Amaryl is involved, to Aventis Pharmaceutica at 1-800-633-1610. Medication errors should also be reported to the USP Medication Errors Reporting Program in cooperation with the Institute for Safe Medication Practices 1-800-23ERROR; 1-800-FAIL-SAF) or FDA's MedWatch Adverse Event Reporting Program (1-800-FDA-1088).

Thank you for your attention to this matter.

Ramy Mahmoud, MD, MPH

Vice President, CNS

Janssen Medical Affairs, LLC



Upcoming Events for Pharmacists and Pharmacy Techs.. 2004

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© 2004 RPhLink.com  The Pharmaceutical Care Network! is designed and published by RPhLink. Inc. All Rights Reserved. Owned and Operated by Pharmacists for Pharmacists and Better Pharmaceutical Care.   RPhLink.com is designed by RPhs for Pharmacists & Pharmacy Techs.  For information use only! Disclaimer.


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To: RxLink®



          Carolina Pharmaceuticals, Inc. feels obliged to correct misinformation that you may have received concerning the relulatiory status of Humibid LA and Humibid DM.  The old formulation of Humibid LA was removed from the market in October 2003 at the direction of the FDA.  The new formulation has not been removed fro the market and these products are currently available at pharmacies nationwide.  Carolina Pharmaceuticals, Inc stands behind these products and wants to assure customers that the FDA has not called into questions the safety of its products.

           While we acknowledge that we recently received a warning letter from the FDA regardomg tje regulatory status of these products, we are scheduled to meet with the FDA next week to address the Agency's questions concerning our products Humbid LA and Humbid DM.  We are confident that we can reach a mutually agreeable resolution of this matter with the FDA and will keep you informed regarding the outcome of this meeting.

            Please note that there have been no reports of confusion in the marketplace concerning the re-formulation of Humibid LA and Humibid DM.  Our product labels and promotional materials clearly identify that Humibid LA and Humibid DM have been reformulated.  Most importantly, there have been no reports to date, of adverse events associated with Humibid LA and Humibid DM.

             Carolina Pharmaceuticals, Inc. is committed to providing our customers with safe and effective, high quality and good value pharmaceutical products.  We appreciate your support and your business.

             Please contact me at (919) 462-0565 if you have any additional questions regarding Humibid LA, Humibid DM, or any other Carolina Pharmaceuticals productl


Craig Collard
President & CEO

Carolina Pharmaceuticals, Inc.

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© 2006 RxLink  The Pharmaceutical Care Network! is designed and published by RPhLink. Inc. All Rights Reserved. Owned and Operated by Pharmacists for Pharmacists and Better Pharmaceutical Care.   RxLink is designed by RPhs for Pharmacists & Pharmacy Techs.  For information use only! Disclaimer.


From: Duramed

Subsidiary of Barr Pharmaceuticals, Inc.

Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., is pleased to announce the acquisition of Plan B (levonorgestrel) tablets, 0.75 mg- now the only marketed emergency contraceptive.

Plan B, currently available by prescription, is a progestin-only pill. Since Preven  (levonorgestrel) 0.25 mg/ethinyl estradiol 0.05 mg tablet USP) has been discontinued and is no longer manufactured, Plan B provides a safe and effective alternative for emergency contraception. If you receive any prescription for Preven, you should contact the prescriber and offer Plan B as the safe and effective alternative.

Plan B is not an abortifacient; it is not effective if a women is already pregnant. Plan B can prevent pregnancy in cases of contraceptive failure or unprotected intercourse. For optimal efficacy, a woman must take the first tablet as soon as possible within 72 hours and the second tablet 12 hours later. Plan B can reduce the risk of pregnancy by 89% when taken as directed.

Each packet of Plan B contains a single, 2 tablet course of treatment. The NDC number is 51285-038-93.

Plan B May be appropriate when a woman

-Engaged in intercourse without contraception protection

-Used a barrier methods of contraception that failed during intercourse or failed to follow their contraceptive regimen

-Was raped

Plan B broadens the contraceptive options Duramed offers to women. Our sales force will provide you with materials to support the use of Plan B. Information for professionals and patients is available at www.go2planB.com. Our Plan B information line can be accessed toll free at 1-800-330-1271 from 8AM to 7PM EST.

Stocking Plan B is the critical first step. Order Plan B now from your wholesaler or call 1-800-330-1271. We hope you will help Duramed Pharmaceuticals provide access to women in need of emergency contraception. Stocking Plan B is especially important, since timing is critical to the efficacy of Plan B.

Very Truly Yours,

Ericka Higgins

Product Manager

PS: Coming soon! Duramed Pharmaceuticals will be conducting a full-scale launch of Plan B, complete with new materials for professionals and patients in the near future. In the interim, our sales representatives will be calling on you with patient materials and literature for professionals.

Plan B is contraindicated in women with known or suspected pregnancy, hypersensitivity to any component of the product, or undiagnosed abnormal genital bleeding.

Plan B is not recommended for routine use as a contraceptive. Plan B is not effective in terminating an existing pregnancy. Plan B does not protect against HIV infection and other sexually transmitted diseases (STDs).

Menstrual bleeding may be heavier or lighter after taking Plan B. If menses are delayed beyond one week, pregnancy should be considered. Severe abdominal pain may signal a tubal (ectopic) pregnancy.

Common side effects associated with the use of Plan B include nausea, abdominal pain, fatigue, headache, and menstrual changed.



©2006 RxLink The Pharmaceutical Care Network!

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To: RxLink

From: Morton Grove Pharmaceuticals

Important new information about Lindane Shampoo and Lindane Lotion, USP 1%

April 2004

Dear RxLink Pharmacist:

Have you been receiving the most accurate information about Lindane Shampoo and Lotion?

Lindane Shampoo (AT rated to Kwell Shampoo) and Lindane Lotion (AT rated to Kwell Lotion) are both effective second-line therapies that are prescribed by physicians when other medicines have been tried and have failed. Both therapies are sold only under a physician's prescription. Lindane Shampoo is an effective second-line therapy for head lice, while Lindane Lotion is an effective therapy for treatment of scabies.

While these products are both useful and effective when needed, it is essential that they are used only in accordance with the directions provided. Seizures and fatalities have been reported following Lindane use with repeated or prolonged application but also in rare cases following a single application reportedly used according to directions. Also, central nervous system stimulation as mild as dizziness has occurred. We ask for your assistance to assure appropriate use. Morton Grove Pharmaceuticals, in conjunction with the FDA, has taken the following measures designed to help prevent improper use of these medications.

-Lindane Shampoo and Lotion are now supplied in 2-oz bottles only. The 2-oz bottle is a single application, which will help prevent patients from using more than the recommended dosage in accordance with the physician's prescription.

-A medication guide containing full prescribing and usage information has been attached to each carton of Lindane Shampoo and Lindane Lotion. This guide gives the patient information and instructions needed to assure optimum safety and effectiveness.

-Use special care when prescribing to patients who may be especially prone to side effects or adverse events, such as pregnant and nursing mothers, the elderly, and children weighing less than 110 pounds.

-A complete package insert has been built into the label.

Thank you for your attention to this important matter. We are confident that these practices will assist pharmacists, physicians, and patients in assuring the proper use of Lindane Shampoo and Lotion.

Please refer to the enclosed prescribing information for complete details.

P.S. For further information about the appropriate use of Lindane products, visit http://www.fda.gov/cder/drug/infopage/lindane/lindaneQA.htm


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