FDA approves generic hypertension drugs, looks at Stalevo

Recalls, warnings, approvals and other regulatory news.

Recalls, warnings

A recall of four lots of Prevnar pneumococcal 7-valent conjugate vaccine because the syringes may have unapproved tip caps.


A recall of Camolyn eye drops and Fisiolin nasal drops because the manufacturer cannot assure sterility.

A boxed warning added to propylthiouracil, a drug used to treat hyperthyroidism, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal. The new warning also states that it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments or for women during and just before the first trimester of pregnancy.

A voluntary recall of certain lots of cuffed Shiley tracheostomy tubes and custom/specialty tracheostomy tubes because the cuff may not hold air as a result of leaks in the pilot balloon inflation assembly. The ability to generate positive pressure in the airway could be compromised by lack of cuff seal.

A voluntary recall of certain over-the-counter children's and infants' liquid products manufactured by McNeil Consumer Healthcare, including Tylenol, Motrin, Zyrtec and Benadryl products, because they may not meet required quality standards.


A new use of rifaximin (Xifaxan). Previously approved for the treatment of traveler's diarrhea, the drug can now be used for reduction in the risk for recurrence of overt hepatic encephalopathy in patients with advanced liver disease.

Polidocanol (Asclera), an injection to close spider veins (tiny varicose veins less than 1 mm in diameter) and reticular veins (those that are 1 to 3 mm in diameter). The drug acts by damaging the cell lining of blood vessels. Common adverse reactions include hematoma, bruising, irritation, discoloration and pain at the injection site.

A new formulation of OxyContin, intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved in order to discourage misuse and abuse of the opioid medication.

TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

The first generic versions of losartan potassium tablets (Cozaar) and combination losartan potassium and hydrochlorothiazide tablets (Hyzaar). The widely used antihypertensive drugs will carry the same safety warnings as the branded versions, including a boxed warning against use during the second and third trimesters of pregnancy.

Pancreaze delayed-release capsules, a pancreatic enzyme product, to improve food digestion in patients whose bodies do not produce enough pancreatic enzymes, such as those with cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas. Unapproved versions of pancreatic enzyme products have been available for many years, and Pancreaze is the third product to receive FDA approval.

Temporary permission for the importation of Fresenius Propoven 1%, a product approved in other countries but not by the FDA, into the U.S. because of shortages of propofol injection.


The FDA is currently studying whether Stalevo, a Parkinson's disease medication, is associated with an increased risk for developing prostate cancer. The agency is reviewing data from STRIDE-PD, a trial in which patients taking Stalevo were compared to those taking carbidopa and levodopa (Sinemet). Researchers unexpectedly found that more patients taking Stalevo were observed to have prostate cancer. While the review is ongoing, the agency is making no new conclusions or recommendations about the use of the drug. Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan.

Laboratory studies have confirmed a recent FDA warning that heparin made under the new United States Pharmacopeia (USP) Monograph has approximately 10% less anticoagulant activity compared to heparin prepared using the previous USP Monograph. The results reinforce the previous recommendation for health care professionals to exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the decrease in potency may require dosage adjustments and more frequent monitoring.

The FDA recently announced that some metered-dose inhalers used to treat asthma and chronic obstructive pulmonary disease will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), and their removal is required by international agreements about ozone depletion. Alternative medications that do not contain CFCs are available.

Triclosan, a common ingredient added to many consumer products to reduce or prevent bacterial contamination, is being reviewed by the FDA, in light of animal studies raising questions about its safety. The agency does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

The FDA has begun a new initiative to address safety problems associated with external infusion pumps, about which the agency has received more than 56,000 reports of adverse events in the past five years. The initiative will include additional pre-market requirements for infusion pumps, a public workshop on infusion pump design, and a new Web page devoted to infusion pump safety.