FDA requires boxed warning for promethazine.

FDA requires boxed warning for promethazine.

The AP (9/17, Johnson) reports, "Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation," according to the FDA. Regulators said that "makers of generic promethazine will have to put a [boxed] warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

MedPage Today (9/16, Peck) reported, "The new label also warns that there is 'a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.'"

Medscape (9/16, Rebelo) reported, "The FDA is also requiring a revision in the Dosage and Administration section of the drug's labeling to highlight 'specific recommendations for the maximum concentration (25 mg/mL) and rate of administration (25 mg/min) when intravenous administration of promethazine is required.'"

FDA says Tysabri linked to 13 cases of PML since 2006 re-introduction.

Bloomberg News (9/17, Larkin) reports, "Biogen Idec Inc. and Elan Plc's Tysabri [natalizumab] has been linked to 13 cases of a deadly brain disease" -- progressive multifocal leukoencephalopathy (PML) -- "since the drug was reintroduced in July 2006, regulators said." The FDA on Wednesday posted on its website new "safety information for the treatment for relapsed multiple sclerosis and Crohn's disease."

The Dow Jones Newswire (9/17, Gryta, subscription required) adds that Tysabri's label has not changed and the FDA said that the overall rate of patients developing PML is below the one-in-1,000 rate listed on the drug's label. Still, the agency warned that the risk of PML "appears to increase with the number of Tysabri infusions received," and that 25 was the average number of infusions received before the PML diagnosis.

FDA says Allergan's Latisse website omits risk information.

The Wall Street Journal (9/17, Favole, subscription required) reports that the FDA said Allergan Inc.'s website for Latisse, its eyelash thickener, omits risk information about the product. A Sept. 10 letter to Allergan stated that the company's website lacks information about the risk of bacterial keratitis from using Latisse.

Bloomberg News (9/17, Larkin) reports that regulators said, "Materials that promote a drug's benefits must also address its risks, which in this case include allergic reactions or hair growth outside the treatment area." The FDA "ordered Allergan to reply by Sept. 24 with a plan to discontinue use of these types of promotions."

The Orange County Business Journal (9/16, Reed) reported, "Allergan said that it's working closely with the FDA to address the concerns," and that "it's no longer using an exhibit that described the evolution of lash enhancers, which drew the regulators' objections." Reuters (9/17, Richwine) also covers the story.