Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PR Newswire; Tuesday July 28, 1998
"We have encountered an undesired formation of a Norvir crystalline structure that affects how the capsule form of Norvir dissolves," said Arthur Higgins, senior vice president, pharmaceutical operations, Abbott Laboratories.
"Although maximum efforts are underway, to date we do not have a solution to the capsule problem."
The manufacturing difficulties with Norvir capsules will result in shortages and interruption in supply of capsules. Abbott is planning to supply Norvir oral solution (liquid formulation) to provide continued Norvir therapy for patients. Norvir capsules currently in distribution are not affected by this issue. When used in accordance with the prescribing information, product on the market is safe and effective.
"We deeply regret this inconvenience," said Higgins. "Abbott is committed to doing everything it can to enable patients to continue Norvir therapy without interruption, and to resuming timely delivery of Norvir capsules." The active ingredients in Norvir liquid and Norvir capsules are identical, as is their activity against HIV.
Pharmacists and physicians are being informed of dosing instructions to address the capsule-to-liquid conversion.
Abbott has contacted and is working with the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other international regulatory agencies to address the problem. Abbott will be communicating with health care providers, consumers and the AIDS community through letters.
In addition, the company has set up a toll-free number for inquiries and has placed information on its website. For health care provider and patient questions regarding Norvir liquid in the United States, call 1-800-637-2400 or visit www.norvir.com. For outside the United States, please see phone numbers below.
Norvir is indicated in adults in combination with other anti-retroviral agents or, in the United States, as monotherapy for the treatment of HIV infection. Norvir has also been cleared by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data.
Norvir may not be right for everyone, including people with liver disease, hepatitis, or hemophilia. Elevated blood sugar levels have been reported in patients taking protease inhibitors. Allergic reactions ranging from mild to severe have been reported. Common adverse reactions include fatigue, vomiting, diarrhea, loss of appetite, abdominal pain, taste disturbance, tingling sensation or numbness in the hands, feet, or around the lips, headache and dizziness. Frequently observed adverse events may diminish as therapy is continued. Norvir should not be used with certain medications including some non-sedating antihistamines, sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations.
Recent projections estimated $250 million of Norvir sales for the entire year of 1998. While the company cannot at this time predict the impact of this Norvir substitution on sales, Abbott remains committed to meeting its stated goal of low double-digit earnings per share growth.
Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 54,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's website at http://www.abbott.com. For health care provider and patient questions regarding Norvir liquid outside the United States:
Argentina (54-1) 382-7227
Austria (43-1) 664-254 6172
Australia (61-2) 419 922 409
Belgium (32-10) 475-430
Brazil (55-11) 536-7000
General (55-11) 0800-555554
Norvir line (55-11) 536-7090
Medical Director Canada (514) 832-7000
Chile (56-2) 557-6062 Ext. 219
China (8621) 6355-8777
Colombia (57-1) 413-8101
Czech Republic (420-2) 672-92-111
Denmark (45-45) 67-01-01
Dominican Republic (809) 566-2938
Dubai (Middle East) (971-4) 21-2711
Ecuador (593-2) 569-971 (Ext. 232)
Finland (358-9) 7518-4121
France (33-1) 4560-2591
Germany (49-6122) 58-2087
Greece (30-1) 9985-555
Guatemala (502) 595-5088
Hong Kong (852) 2806-4841
Hungary (36-1) 351-2113
India (91-22) 267-2159
Ireland (353-1) 451-7388
Italy (39-06 928-92 824
Japan (81-6) 942-8450
Korea (82-2) 3429-9300
Malaysia (60-3) 519-3388
Mexico (525) 726-4648
Netherlands (31-23) 55-44-450
New Zealand (64-4) 567-0039
Norway (47-66) 983-770
Pakistan (92-21) 501-5045
Peru (51-1) 461-4791 ext. 266
Philippines (63-2) 631-8471
Poland (48-22) 601 30 43 19 (Specify GSM System)
Portugal (35-1) 472-7124
Puerto Rico (787) 750-5454
Russia (70-95) 915-8971
Saudi Arabia (966-1) 464-0764
Singapore (65) 278-7366
South Africa (27-11) 494-4267
Spain (34-91) 337-5288
Sweden(46-8) 703-6710
Switzerland (41-41) 768-43-17
Switzerland (Eastern Europe) (41-41) 768-43-68
Taiwan (886-2) 2505-0828
Thailand (66-2) 267-9028
Turkey (90-216) 425-0962
UK (44-1 0800 018 3340
Uruguay (598-2) 514-4712
Venezuela (58-2) 238-1551
SOURCE: Abbott Laboratories
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Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.
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