FDA unsure about contaminant in heparin
WASHINGTON The Food and Drug Administration stated that a yet unknown contaminant was found in batches of the active ingredient used in Baxter International’s blood thinner heparin, according to the Wall Street Journal. Baxter stopped manufacturing the drug last month and recalled some of its heparin products as a result.
FDA officials said 19 reports of death, up from a previous total of four, now appear to match the allergic-type and low blood-pressure reactions that have been the main focus of safety concerns. It wasn’t clear how many of the 19 people took the Baxter product. The deaths occurred since Jan. 1, 2007, but the FDA only received the reports in the past three months or so, the agency said.
Baxter yesterday said it believed four patients had “suffered an allergic-type reaction to heparin that may have contributed” to a fatal outcome.
Rival heparin maker APP Pharmaceuticals said it hasn’t gotten any reports of allergic-type reactions of the type Baxter and the FDA are describing. The agency said it has now received a total of 785 reports of problems in patients who took some form of heparin, though it isn’t clear that these are all related to drug reactions and some may be duplicates.
FDA officials said there was an “association” between batches with the contaminant and patient reactions, but the agency hasn’t yet concluded there is a direct causal link. It said the source of APP’s active ingredient hadn’t shown a similar contaminant.
Baxter said the questionable heparin had been made from a Chinese raw ingredient. The unknown substance was a “natural or biologic material,” and there is currently “nothing to substantiate” a conclusion that it was a counterfeit product, a company spokeswoman said.
Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
FDA approves Ranbaxy’s generic version of Risperdal
NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.
Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.
Risperdal had sales of $924 million in 2007.