FDA prompts removal of unapproved drugs from market

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.

“Removing these unapproved products from the market will reduce potential risks to consumers,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.  “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products.”

Companies that have previously listed products subject to today’s action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days.  Companies that have not previously listed products subject to today’s action with FDA are expected to stop manufacturing and shipping their products immediately.

Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk.

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative, which began in June 2006.  The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.

Source: U.S. Food & Drug Administration

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FDA rejects filing on Santarus angioedema drug

Santarus Inc. said Monday the Food and Drug Administration did not accept a marketing application for its drug Rhucin, which is designed to treat a genetic disorder that can cause dangerous swelling of the throat and extremities.

The FDA's decision could delay approval of Rhucin for more than a year. The agency wants data from an ongoing late-stage clinical trial, according to Santarus and its partner Pharming Group NV. Pharming started that trial earlier this month, and the company expects it to last a year to 18 months. After the FDA accepts a marketing application for a drug, it generally takes six to 10 months to review it.

Rhucin is a treatment for acute attacks of hereditary angioedema, or HAE. The companies say the FDA did not accept the marketing application because the previous clinical studies did not provide data on enough patients to support the proposed dose. The agency also said the studies did not have validation of a visual scale used to measure the drug's effects on the symptoms of HAE.

The companies said they will meet with the FDA to discuss its decision. The agency also plans to give other feedback on the design of the late-stage study, which is expected to involve about 50 patients. Santarus and Pharming say Rhucin has been tested on 190 patients in nine clinical trials.

Rhucin was developed by Pharming, and the drug was approved in Europe in November under the name Ruconest. Santarus, which is based in San Diego, holds the rights to the drug in North America. Pharming, which is based in the Netherlands, filed for FDA approval of Rhucin in late December.

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FDA warns against certain uses of asthma drug terbutaline for preterm labor

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.

Source: U.S. Food & Drug Administration

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FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers

The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhalerused to treat patients with asthma and chronic obstructive pulmonary disease.

The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and the FDA continues to aggressively investigate the matter.

Stolen medicine may be harmful because it may have been stored at the wrong temperature or humidity or other improper conditions, may degrade or lose potency, become contaminated, or may have been tampered with or handled improperly while outside of the legitimate supply chain.

The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

• Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
• Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)

Patients who have products with these lot numbers should immediately stop using them, contact GlaxoSmithKline’s Customer Response Center at 888-825-5249, and follow-up with their physician or pharmacist to obtain a proper replacement.

Pharmacists and wholesalers who find Advair Diskus inhalers bearing these lot numbers should remove them from shelves and contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989. The agency also is asking for the public's help in reporting any information regarding these inhalers, including suspicious or unsolicited offers for the Advair Diskus lots in question, to OCI or by visiting the OCI website.

The FDA invites pharmacists and wholesalers to visit the FDA’s Cargo Theft Web page to check their inventory for other stolen products. The FDA is committed to protecting American consumers from the threat of stolen, counterfeit, and diverted FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

Source: U.S. Food and Drug Administration

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FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

Qualaquin is not FDA-approved to treat or prevent night time leg cramps.

A review of reports submitted to the FDA’s Adverse Event Reporting System (AERS) between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin.

Quinine use resulted in serious and life-threatening reactions in 24 cases, including low level of platelets in the blood (thrombocytopenia), and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura, a blood disorder that results in clots in small blood vessels around the body that can be accompanied by kidney impairment.

Malaria: Drugs, Disease and Post-genomic Biology

In some patients, these side effects resulted in permanent kidney impairment and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome.

The risk management plan, called a Risk Evaluation and Mitigation Strategy (REMS), requires that patients be given a Medication Guide explaining what Qualaquin is and is not approved for, as well as the potential side effects of the drug. The company is also required to issue a Dear Health Care Provider Letter warning of the potential risk of serious and life-threatening blood-related (hematologic) reactions.

“Health care professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of night time leg cramps,” said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “FDA has received reports that some patients have developed serious side effects when taking quinine for night time leg cramps.”

Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated. According to the U.S. Centers for Disease Control and Prevention, about 1,500 cases of malaria are diagnosed in the United States each year, primarily resulting from travel abroad.

Qualaquin is marketed by Philadelphia-based AR Scientific.

Health care professionals and patients may report serious adverse events (side effects) to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.

Source: U.S.Food and Drug Administration

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