FDA Clears Generic Wellbutrin
The generic formulation of Wellbutrin XL (300 mg) is bioequivalent to the brand, the Food and Drug Administration has determined. The agency began a review of generic bupropion after receiving 85 adverse event reports in the first 6 months of 2007. Seventy-eight patients said they had experienced loss of antidepressant effect when they were switched from the branded product to the generic manufactured by Teva Pharmaceutical Industries Ltd. The Teva product was approved in 2006, but at the 150-mg dose and based on bioequivalence to 150 mg of Wellbutrin XL, according to the FDA, which noted that the pharmacokinetic profile was not expected to differ between the 150-mg and 300-mg doses. After the rash of adverse event reports, the agency again reviewed the bioequivalence data and the literature on natural history of depression. The FDA concluded that there was no difference between the two products. Also, if there was a link to the generic, there should have been many more reports, said the FDA, noting that by early 2007, at least 40% of bupropion prescriptions were for the generic. The agency added, “The recurrent nature of major depressive disorder offers a scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product.”
Teva to Market Generic Risperdal
A U.S. District Court judge in Washington, has ruled that Teva Pharmaceutical Industries Ltd. has the right to make and sell a generic version of Risperdal (risperidone). Unless the ruling is challenged, Teva can begin exclusive sales of risperidone on June 29, the date Johnson & Johnson's patent for Risperdal expires. The FDA and generic pharmaceutical manufacturer Mylan Inc. had argued that Teva should not be allowed to have exclusive rights to the generic version of the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the meantime, J&J and its partner Alkermes Inc. have applied to the FDA to sell a long-acting form of the drug, Risperdal Consta, for frequently relapsing bipolar disorder, defined as four or more manic episodes in the previous year. Alkermes estimates that 10%–20% of people with bipolar disorder worldwide meet that criterion.
Zyprexa Lawsuits March On
Eli Lilly & Co. agreed to pay the state of Alaska $15 million to settle charges that it was not forthcoming about side effects such as weight gain, hyperglycemia, and diabetes related to Zyprexa (olanzapine). But the company is facing a separate suit filed by Connecticut Attorney General Richard Blumenthal in mid-March, alleging concealment of side effects and illegal promotion of off-label uses. Lilly is also negotiating with the U.S. Attorney for the Eastern District of Pennsylvania in an inquiry related to marketing practices. The Alaska settlement came several weeks into a suit brought on behalf of the state's Medicaid program. The company said in a statement that it settled to avoid the cost of a lengthy trial. Zyprexa has been prescribed to 23 million people since its 1996 approval and is approved in 80 other countries. In 2007, sales were $4.8 billion worldwide.
Social Anxiety's Serious Impact
A survey commissioned by the Anxiety Disorders Association of America has found that about a third of the respondents with social anxiety disorder said that they had symptoms for 10 years or more before seeking help. The survey portrayed individuals who had difficulty finding or keeping friends or romantic partners. Thirty-four percent said the disorder led to serious fights with significant others, and 77% said that when they are not treated, the disorder has a negative impact on romantic relationships. Seventy-five percent said social anxiety inhibited their ability to function normally. Fifty-eight percent said they were embarrassed by their disorder. Patients with social anxiety disorder typically try to hide their condition, and therefore become more anxious and isolated, according to the association. Survey respondents indicated that treatment seems to help: 59% who were treated said it helped them have romantic relationships. The survey was conducted in December; 578 people with anxiety, 276 people with obsessive-compulsive disorder, and 287 with social anxiety disorder were queried by Harris Interactive. All agreed to be invited to participate. The ADAA received an unrestricted educational grant from Jazz Pharmaceuticals Inc. to support public awareness efforts about the disorder.
Side Effects Underreported
One in six Americans who have taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but only 35% of consumers said they know they can report these side effects to the FDA, according to a Consumer Reports poll. Additionally, 81% of respondents said they had seen or heard an ad for prescription drugs within the last 30 days, almost all on television. The Consumers Union, the nonprofit publisher of the magazine, gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and Web site be included in all television drug ads so people can easily report their serious side effects. “What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and Web site in all those drug ads we're bombarded by each day?” asked Liz Foley, campaign coordinator with Consumers Union, in a statement.