Warning about mixing protease inhibitors with statins

This regulatory update includes a warning on combining protease inhibitors and statins, approval of an orphan drug, and steps the FDA is taking to increase the supply of cancer drugs.

Recalls and warnings

A labeling change to protease inhibitors about interaction risks with statins. Co-administration of HIV or hepatitis C protease inhibitors with certain statins can increase the risk of myopathy/rhabdomyolysis. Clinicians should follow the recommendations on the drug labels when prescribing these drugs.


A recall of one lot (F73652) of Prevnar 13 pneumococcal 13-valent conjugate vaccine 0.5-mL pre-filled syringes because the lot was formulated and filled with expired serotype 3 conjugate material.

A recall of additional lots of norgestimate and ethinyl estradiol tablets due to the possibility of out-of-sequence tablets, this time from Glenmark Generics Inc. Affected doses include 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg.

A recall of certain lots of Smiths Medical Bivona neonatal, pediatric and FlexTend tracheostomy tubes because difficulty disconnecting accessories from the connectors of the affected tubes may result in use of excessive force, and the tracheostomy tubes may dislodge from patients. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

A recall of three lots of Bedford Laboratories' cytarabine for injection after an inspection revealed potentially elevated risk of lack of sterility in the manufacturing process.

A recall of infant Tylenol oral suspension, 1 oz grape, after consumers reported difficulty using the medication's dosing system. No adverse events have been reported to date.

A recall of CareFusion's Nicolet cortical stimulator control unit because the device's software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. These issues may result in the surgeon resecting the wrong brain tissue.

A recall of one lot (0693) of American Regent's phenylephrine HCl injection, USP, 1% (10 mg/mL), 5 mL, due to visible particles.

A recall of certain automatic external defibrillators (AEDs), which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. Affected AEDs include Cardiac Science Powerheart, CardioVive, and CardioLife; GE Responder and Responder Pro; and Nihon Kohden.

A recall of the alarm cable for the Newport HT50 Ventilator because it may cause an electrical shortage that can cause the ventilator to shut down unexpectedly.


Mifepristone (Korlym) to control hyperglycemia in adults with endogenous Cushing's syndrome. The drug was approved for use in patients with this syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery, but it is contraindicated in pregnant women. The safety and efficacy of this orphan drug were evaluated in a clinical trial with 50 patients.

An expanded approval for BreathTek UBT to detect Helicobacter pylori bacterial infections in children age 3 to 17 years. Approval was based on a multi-center study of 176 patients, comparing the test's performance to a composite reference method and demonstrating 95.8% sensitivity and 99.2% specificity. The test was approved for adults in 1996.

Pancrelipase (Ultresa and Viokace) to help aid food digestion. Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes. Viokace, in combination with a proton-pump inhibitor, is used to treat adults who cannot digest food normally, such as those with chronic pancreatitis or pancreatectomy. Unapproved pancreatic enzyme products had been available for many years. The FDA established a date of April 28, 2010 for the makers of pancreatic enzyme products to stop manufacturing and distributing unapproved products.

Lucinactant (Surfaxin) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. A single randomized, active-controlled, multi-dose study involving 1,294 premature infants demonstrated the safety and efficacy of the drug.


The FDA has announced a series of steps to increase the supply of critically needed cancer drugs.

In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection), there will be temporary importation of a replacement drug, LipoDox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks.

In response to rapidly declining supplies of methotrexate, the agency has approved a new manufacturer of a preservative-free formulation of methotrexate that is expected to bolster supply and help avert a shortage.

The FDA also issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption.