Omeprazole (Prilosec) approved for OTC heartburn treatment
The U.S. Food and Drug Administration (FDA) has approved the proton pump inhibitor omeprazole (Prilosec) for sale over-the-counter (OTC) to treat frequent heartburn.
Unlike the two classes of currently marketed over-the-counter heartburn treatments, antacids and acid reducers, omeprazole OTC is indicated for the treatment of heartburn that occurs two or more days per week (frequent heartburn).
Prilosec OTC is a delayed-release 20 mg tablet that must be taken before eating once a day, every day for 14 days. Prilosec OTC may take one to four days to achieve full effect, although some consumers may get complete relief of symptoms within 24 hours.
Prilosec OTC is being brought to the over-the-counter market through an alliance between The Procter & Gamble Co. and AstraZeneca.
AstraZeneca will continue to make prescription omeprazole and its other acid inhibitor, esomeprazole magnesium (Nexium). Prescription omeprazole, first approved by the FDA in 1989, still will be available as a prescription treatment for diseases that require diagnosis and supervision by a doctor, such as gastroesophageal reflux disease, inflammation of the esophagus (esophagitis), and ulcers.
Because of the safety studies performed by the manufacturer of Prilosec OTC, this product will have three years of OTC exclusivity. Generic versions of the prescription product will not be able to market an OTC version until the marketing exclusivity has expired.
Recall includes all repacked atorvastatin products
The FDA has announced that its continuing investigation of counterfeit atorvastatin calcium (Lipitor) has resulted in Albers Medical Distributors, of Kansas City, MO, expanding its recall to include all Lipitor products repacked by Med-Pro, of Lexington, NE. In addition, H.D. Smith Wholesale Drug Co., of Springfield, IL, has recalled all Lipitor products repacked by Med-Pro.
The FDA also announced that its Forensic Chemistry Center in Cincinnati has determined that the counterfeit tablets that have been tested as of this date contain atorvastatin. The Forensic Chemistry Center’s analysis to date has not identified any known harmful substances in the counterfeit tablets, although analytical testing continues.
Despite these results, FDA cannot assure that the counterfeit products are safe and effective. Individual tablets of this counterfeit medicine may vary significantly, even within individual lots, because the source of the atorvastatin is unknown and because there is no evidence that the tablets have been produced according to good manufacturing practices that are meant to ensure consistency from batch to batch.
Consequently, FDA’s advice to health care providers and consumers remains the same as when the agency issued its original alert on counterfeit Lipitor on May 23, 2003. Patients who have any of the product labeled as "Repackaged by: MED-PRO Inc.; Lexington, NE 68850" should not take it, and they should return the product to their pharmacy. Patients who are not sure whether they have the recalled product should check with their pharmacist.
Paroxetine (Paxil) should not be used in children
The FDA is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents younger than age 18 treated with the drug paroxetine (Paxil) for major depressive disorder (MDD). Although the FDA has not completed its evaluation of the new safety data, FDA is recommending that paroxetine not be used in children and adolescents for the treatment of MDD. There currently is no evidence that paroxetine is effective in children or adolescents with MDD, and paroxetine is not currently approved for use in children and adolescents. Other approved treatment options are available for depression in children.
Three well-controlled trials in pediatric patients with MDD failed to show that the drug was more effective than placebo. The new safety information that currently is under review was derived from trials of paroxetine in pediatric patients.
The FDA advises that caretakers of pediatric patients already receiving treatment with paroxetine for MDD to talk to their doctor before stopping use of the drug. Patients should not discontinue use of paroxetine without first consulting their physicians, and it is important that paroxetine not be discontinued abruptly.
FDA announces pilot program to post warning letter responses
The FDA has announced that it will begin a pilot program to post recipients’ responses to FDA warning letters on the agency’s web site.
In compliance with the Electronic Freedom of Information Act Amendments, the FDA posts on its web site warning letters that are or are likely to be frequently requested documents under the Freedom of Information Act (FOIA). However, the FDA does not post recipients’ written responses to warning letters. Under the pilot program, which will begin in the fall and continue for six months, warning letter recipients who wish to have their responses made public will be able to request that the agency do so.
Responses submitted to the FDA with a request that they be posted and in a word processing format will be considered for the pilot program. After six months, the FDA will evaluate the pilot and determine whether the program should become permanent.
If during the pilot program the agency determines that the public is being misled, experiences undue burden in dealing with the process, or finds that the process is too resource-intensive, the FDA may discontinue the program.
The pilot program is a partial response to a 1999 citizen’s petition, which asked the agency to draft regulatory procedures that would require the agency to promptly post, to the extent permitted under FOIA, agency records related to any previously posted warning letters.
Omeprazole (Prilosec) approved for OTC heartburn treatment; Recall includes all repacked atorvastatin products; Paroxetine (Paxil) should not be used in children; FDA announces pilot program to post warning letter responsesYou have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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