TOPAMAX® may cause high blood ammonia levels. TOPAMAX® may cause eye problems. You can enroll in this registry by calling 1-888-233-2334. There may be other medicines to treat your condition that have a lower chance of birth defects. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ortho-McNeil Neurologics and/or Johnson & Johnson. Company profile page for Ortho-McNeil Neurologics Inc including stock price, company news, press releases, executives, board members, and contact information (these users are visible on your Newsroom as contacts for journalists), (these users are faculty profiles in the Newswise Expert Directory and are not shown under the list of media contacts on your Newsroom), (these users are hidden from view in your Newsroom, but they may still be able to upload releases and perform other tasks depending on their individual settings). Ortho-McNeil Neurologics, Inc. The company was formed from the merger of Ortho Pharmaceutical and McNeil Pharmaceutical in 1993.

Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures - read this article along with other careers information, tips and advice on BioSpace These are not all the possible side effects of TOPAMAX®. Pay attention to any changes and call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), or other unusual changes in behavior or mood.

Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Newswise registered institution Ortho-McNeil Neurologics up-to-the-minute news, press releases, and expert sources for journalists in science, health, medicine, life news, and business About Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Headquartered in Titusville, N.J., Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a Johnson & Johnson company that focuses exclusively on providing solutions that improve neurological health. Call your doctor immediately if you get these symptoms. Do not stop taking TOPAMAX® without first talking to your doctor.

In conjunction with internal and external research partners, the Company continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology. Neither Ortho-McNeil Neurologics nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

Both of these pharmaceutical companies are pioneers and leaders in areas such as pain management, acid reflux disease, and infectious diseases. TOPAMAX® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness. If you become pregnant while taking TOPAMAX®, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. TOPAMAX® 100mg Tablets are yellow debossed with "OMN" on one side and "100" on the other. Newswise gives journalists access to the latest news and provides a platform for These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico. These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico. Live - These defects can begin early in pregnancy, even before you know you are pregnant. You and your healthcare provider should decide if you will continue to take TOPAMAX® while you are pregnant. Event in Progress, Newswise

Ortho-McNeil and Janssen Pharmaceutica together compose the Ortho-McNeil-Janssen group within Johnson & Johnson.

All Rights Reserved. Learn how and when to remove this template message, Biotech and pharmaceutical companies in the New York metropolitan area, Johnson & Johnson Pharmaceutical Research and Development, Dr. Paul Janssen Award for Biomedical Research, Steve Patterson Award for Excellence in Sports Philanthropy, Global Health Innovative Technology Fund (GHIT), 2010 Johnson & Johnson children's product recall, Pharmaceutical companies of the United States, https://en.wikipedia.org/w/index.php?title=Ortho-McNeil_Pharmaceutical&oldid=970549074, Pharmaceutical companies based in New Jersey, Pharmaceutical companies established in 1993, Articles lacking sources from January 2020, Creative Commons Attribution-ShareAlike License, This page was last edited on 31 July 2020, at 23:42. Stopping TOPAMAX® suddenly can cause serious problems. Titusville, N.J., April 14, 2011 - Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling two lots of TOPAMAX® (topiramate) 100mg Tablets.

Progress.

The voluntary recall, being implemented in cooperation with the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated odor-related reports. These eye problems can lead to permanent loss of vision if not treated.

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Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease. The Company currently has products for Alzheimer's disease, epilepsy, and acute and preventive migraine treatment. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. Event in 265 Turkey Sag Trail, Suite 102, #110, Palmyra VA 22963, Newswise Your use of the information on this site is subject to the terms of our Legal Notice. Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX ®. All contents © Copyright Johnson & Johnson Services, Inc.1997-2020. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The company was formed from the merger of Ortho Pharmaceutical and McNeil Pharmaceutical in 1993. In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood. Please see our Privacy Policy. You should call your healthcare professional right away if you have any new eye symptoms. Report any side effect that bothers you or that does not go away. As it relates to TOPAMAX®, there have been no reported serious adverse events caused by the presence of TBA. universities, institutions, and journalists to spread breaking news to their Tell your healthcare provider right away if you become pregnant while taking TOPAMAX®.

TOPAMAX® may cause decreased sweating and increased body temperature (fever). Some people may need to be hospitalized for this condition. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms. If the decision is made to use TOPAMAX®, you should use effective birth control (contraception) unless you are planning to become pregnant. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Ortho-McNeil and Janssen Pharmaceutica together compose the Ortho-McNeil-Janssen group within Johnson & Johnson. All contents © Copyright Johnson & Johnson Services, Inc.1997-2018. Johnson & Johnson Medical Devices Companies. 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome; and for adults for the prophylaxis of migraine headache. Live - High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. All Rights Reserved. Your doctor may want to do simple blood tests.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Ortho-McNeil is headquartered in Raritan, New Jersey, United States. Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®, Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX, This site uses cookies as described in our. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat, or changes in the level of alertness. The Company does not anticipate a product shortage resulting from this action. While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace. Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This site is governed solely by applicable U.S. laws and governmental regulations.



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