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AS PROBLEMS SURFACE, CONSUMERLAB.COM AND THE PEOPLE'S PHARMACY ASK FDA TO DISCLOSE DIFFERENCES BETWEEN GENERIC AND ORIGINAL DRUGS

-- Generic Anti-Hypertensive Differs from Original and May Raise Blood Pressure; Wait Continues on FDA's Investigation of Problematic Generic Anti-Depressant --

WHITE PLAINS, NEW YORK AND DURHAM, NORTH CAROLINA — MARCH 17, 2008 — An investigation by ConsumerLab.com of generic versions of the popular anti-hypertensive Toprol XL reveals that generics sold by two companies appear to differ from the original drug in how they dissolve and in their inactive ingredients. These differences may help explain complaints by consumers who have been switched to a generic version. Prior to generic competition, which began in late 2006, annual sales of Toprol XL were $1.7 billion according to IMS Health, placing it among the top-selling anti-hypertensive medications.

Dramatic increases in blood pressure and increased heart rate are among the complaints reported by people switched to generic versions of Toprol XL. Other reported side effects include nausea, dizziness, hives and headaches, including migraines — most of which do not typically occur with Toprol XL. The reported symptoms generally subside when returned to the original drug. ConsumerLab.com has received complaints through its report form at http://www.consumerlab.com/GenericReport.asp. Complaints received by The People's Pharmacy appear at www.PeoplesPharmacy.com.

ConsumerLab.com's report compares Toprol XL to generics sold by Eon Labs (a division of Sandoz), Ethex (a division of KV Pharmaceutical), and Par Pharmaceutical. Some of the generics contain multiple inactive ingredients not present in Toprol XL, a potential issue for people with chemical sensitivities. ConsumerLab.com also found that some generics sold as "Metoprolol Succinate Extended-release Tablets USP" may not comply with the official USP dissolution test. This is of concern because the rate at which a generic dissolves may affect the rate at which it enters the blood. If blood levels for a generic differ from that of its counterpart original, it may not perform the same way. Use of "USP" in the name of a generic may also lead pharmacists and physicians to believe that it behaves like the original Toprol XL, when that may not be the case.

The new report is found at www.consumerlab.com/reviews/Toprol_vs_Generic_Metoprolol/toprol/. In addition to product comparisons, the report provides useful strategies for obtaining a desired brand at low cost.

Update on Generic Wellbutrin XL:
Shortly after ConsumerLab.com's report in October 2007 of potential problems with a generic version of the anti-depressant Wellbutrin XL, the FDA announced an investigation of the generic distributed by Teva Pharmaceuticals and manufactured by Impax Laboratories. The FDA has yet to disclose its results, but recent events corroborate ConsumerLab.com's findings: A high-ranking FDA official, Dr. Robert Temple, noted in a radio interview that human bioequivalence tests showed the generic to release ingredient sooner than Wellbutrin XL. The United States Pharmacopeia (USP) published information indicating that this generic releases 25% to 50% of its active ingredient during the first two hours of dissolution while original Wellbutrin XL releases less than 20%. ConsumerLab.com notes that it recently learned that several lots of a twice-a-day generic bupropion were recalled by Teva in November for failing to dissolve properly.

Urgent Call for Disclosure:
Today ConsumerLab.com's President, Tod Cooperman, MD, and Joe Graedon, MS, co-author of The People's Pharmacy, urgently call on the FDA to act. "Generics are a great tool to keep healthcare affordable, but not when they may cause harm. We have forwarded well over one hundred case reports to the FDA," said Joe Graedon. Dr. Cooperman added, "It's time for the FDA to let the American public and medical community know when generic drugs are different from their brand-name counterparts. People are suffering, but the FDA continues to withhold information and lead the public to believe that generics perform exactly like the original drugs." ConsumerLab.com and The People's Pharmacy urge the FDA to require that the following information be provided for every generic drug:

  • Inclusion in package inserts of dissolution and bioequivalence results, showing how these differ from the original drug.
  • Inclusion in consumer literature of a list highlighting ingredients not found in the original drug.
  • Publicly accessible reports of adverse events not typical of the original drug.

 

ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. Reviews of popular types of vitamins, supplements, and generic drugs are available at www.consumerlab.com. New Product Reviews to be released in coming months include Fish/Marine Oils (EPA and DHA), Iron, Nutrition Bars, Red Yeast Rice, and investigations of additional generic drugs. Subscription to ConsumerLab.com is available online. The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.

The People's Pharmacy® is a leading provider of consumer health information. Joe Graedon, MS, pharmacology, and Teresa Graedon, PhD, medical anthropology, have been writing a syndicated newspaper column (distributed by King Features Syndicate) for 29 years. They run PeoplesPharmacy.com and co-host The People's Pharmacy® radio show heard on more than 125 public radio stations. They have written more than 10 consumer-related health books that address pharmaceuticals, herbs and dietary supplements.

For further information, contact Tod Cooperman, MD, at tod.cooperman@consumerlab.com, or Joe or Teresa Graedon at peoplespharmacy@gmail.com.



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