Consensi Approved to Treat Osteoarthritis and High Blood Pressure
May 31, 2018 – The U.S. FDA has approved Consensi™ (amlodipine and celecoxib), manufactured by Kitov Pharmaceuticals, to treat patients for whom amlodipine for hypertension and celecoxib for osteoarthritis pain are appropriate therapies.
A once daily pill, Consensi combines a calcium channel blocker (amlodipine) and a COX-2 inhibitor non-steroidal anti-inflammatory drug (celecoxib). Amlodipine was approved by the FDA in 1987 under the brand name Norvasc®, and is available in generic forms. Celecoxib, available both as a generic and under the brand name Celebrex®, was approved in 1998.
Consensi will be available in combinations of 2.5mg, 5mg, or 10mg of amlodipine with 200mg of celecoxib. Patients should take the lowest effective dose for the shortest possible duration, and switch to an alternative treatment for hypertension if pain relief is no longer required. A black box warning indicates that NSAIDs like celecoxib can raise the risk of serious cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal adverse events such as bleeding, ulcers, and perforation of the intestine. The black box warning also cautions that Consensi is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Kitov Pharmaceuticals has not yet announced launch or pricing plans.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.