FDA Fast Facts

US Pharm. 32(11):60-62.

FDA Halts Marketing of Unapproved Hydrocone Products
Companies marketing unapproved drug products containing the narcotic hydrocone must cease or they will be subject to enforcement action, the FDA announced. Hydrocone, used to treat pain and suppress coughs, can cause serious illness or death if not used correctly. The agency is especially concerned about unapproved drugs containing hydrocone being marketed for pediatric use.

"This is another example of the kinds of safety risks that warrant priority enforcement under our Compliance Policy Guide," said Deborah M. Autor, JD, director of the FDA's Center for Drug Evaluation and Research Office of Compliance. "These products need to come off the market until they meet FDA approval standards," Autor said.

Companies marketing unapproved products with hydrocone labeled for use in children under 6 years had until October 31, 2007, to stop manufacturing and distributing the products. Companies marketing any other unapproved hydrocone-containing products must stop manufacturing them by December 31, 2007, and must stop interstate shipment of the products by March 31, 2008.

FDA Proposes Removing CFCs from Asthma Inhalers
The FDA proposed removing the "essential-use" designation for chlorofluorocarbons (CFCs) in epinephrine-containing metered dose inhalers (MDIs) for temporary relief of mild asthma symptoms. The agency initially concluded that there are no technical barriers to formulating epinephrine that does not release CFCs. Currently, MDIs with epinephrine are the only OTC devices for asthma. The proposed rule would mandate that epinephrine MDIs containing CFCs be removed from the market by the end of 2010. Following a 60-day public comment period that starts following publication of the proposed rule in the Federal Register, an open public meeting on the essential use of epinephrine will be held.

The Clean Air Act only permits CFC use in medical products that the FDA deems essential. Since 1978, CFC use has been banned due to deleterious effects on the earth's ozone layer. The majority of MDIs available in the U.S. contained CFCs at one time, but most of these have been reformulated with other propellant substances. Should this rule become final, epinephrine MDI users will need a prescription for alternative drug products if a non-CFC epinephrine inhaler is not available.

Meningitis and Cochlear Implant Connection
Cochlear implant devices used in profoundly deaf or severely hard-of-hearing patients carry increased risk of bacterial meningitis caused by Streptococcus pneumoniae , the FDA warned health care professionals and consumers. Children implanted with cochlear devices with a positioner component, the FDA added, are at a greater risk. Two deaths from meningitis occurred within the past year in children ages 9 and 11 who were implanted with cochlear devices with positioners. Neither child was fully vaccinated; one of the children died due to the lack of vaccination.

According to the CDC's vaccination recommendations, people implanted with this device must be fully immunized. Since children with cochlear implants are at increased risk for pneumococcal meningitis, the CDC recommends that they receive pneumococcal vaccination following the same schedules as other individuals who are at high risk for the disease.

ED Drug Class Linked to Hearing Loss
To clearly display the potential risk of sudden hearing loss and tell consumers what action to take if they do experience this, the FDA approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra.

The FDA asked makers of these drugs to change the product's labeling after a very small number of patients taking the phosphodiesterase type 5 (PDE5) inhibitors reported sudden hearing loss, sometimes with ringing in the ears and dizziness. The FDA also plans to mandate the same changes in labeling for Revatio, a PDE5 inhibitor used to treat pulmonary arterial hypertension.

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention, the FDA said. Revatio users should continue taking the medication but should contact their health care provider for further evaluation. Since Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend that patients abruptly stop taking this medication but says they should consult their physician if they have sudden hearing problems.

The FDA found a total of 29 postmarketing reports of sudden hearing loss following a search through its Adverse Events Reporting System. A report in the April issue of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to look into a possible relationship between hearing loss cases and PDE5 inhibitors. Even though no causal relationship has been demonstrated, the FDA said, a strong relationship between these ED drugs and sudden hearing loss in these cases warrants the labeling revisions in this drug class.

"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it," said Janet Woodcock, MD, the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Initiative Gives Boost to Generics
To increase the number and variety of generic drugs available to consumers and health care providers, the FDA introduced an initiative to modernize and streamline the generic drug approval process. Called the Generic Initiative for Value and Efficiency (GIVE), the program will identify generic drugs with no blocking patents or exclusivity protections and expedite review. Under the program, the FDA will also hire new generic drug reviewers and focus on electronic tools for processing drug submissions, also designed to deliver generics to consumers faste.

"The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high-quality generic drugs during the upcoming fiscal year than it did in 2007," said Gary Buehler, director of the FDA's Office of Generic Drugs. The FDA approved 682 generic drug products in fiscal year 2007, an increase of more than 30% over 2006.

Thyroid Drug's Potency Parameters Tightened
To ensure that the thyroid drug levothyroxine sodium retains its potency throughout its entire shelf life, the FDA is requiring that the drug products meet a 95% to 105% potency specification until their expiration date. These drugs are currently allowed a 90% to 110% potency specification. Manufacturers and marketers of levothyroxine sodium have two years to comply with the revised specifications.

The FDA studied data from approved levothyroxine sodium drug products manufactured between July 2003 and June 2005. Even though all of the drugs retained at least 90% potency, a trend toward potency degradation emerged, particularly with blister packs.

Risks Reported with Psoriasis Drug
The FDA and Roche Pharmaceuticals notified health care providers that the psoriasis drug CellCept (mycophenolate mofetil) is associated with increased risk of first-trimester pregnancy loss and increased risk of congenital malformations,   including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.