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New drugs for Type 2 diabetes are being approved by the Food and Drug Administration (FDA) so frequently that it is hard to keep up. This influx of medications is partly due to production of so-called “me too” drugs, drugs that are so similar in structure to already approved medications that their manufacturers can assume the newer drugs will work the same way.
One of the latest me-too drugs to be approved by the FDA is albiglutide (TANZEUM). It is one of the newest in a class of...
New drugs for Type 2 diabetes are being approved by the Food and Drug Administration (FDA) so frequently that it is hard to keep up. This influx of medications is partly due to production of so-called “me too” drugs, drugs that are so similar in structure to already approved medications that their manufacturers can assume the newer drugs will work the same way.
One of the latest me-too drugs to be approved by the FDA is albiglutide (TANZEUM). It is one of the newest in a class of drugs called glucagon-like peptide-1 (GLP-1) inhibitors. GLP-1 inhibitors are rife with risks of dangerous adverse effects, and albiglutide is no exception. In fact, it may be even more unsafe than other drugs in its class.
About GLP-1 inhibitors
GLP-1 inhibitors are one of the newer classes of drugs to treat Type 2 diabetes. GLP-1 inhibitors act by binding to a protein present on the surface of many organs, including the intestine, pancreas and thyroid. In the pancreas, this binding results in the release of insulin. Because the drug would be broken down in the intestine if taken orally, it must be injected into the skin, either daily or weekly.
Members of this group of drugs share a cluster of adverse effects. Those common to the group as a whole include:
- Pancreatitis, causing abdominal pain, nausea and vomiting.
- Kidney failure, sometimes requiring dialysis.
- Allergic reactions, triggering itching; skin rash; and swelling of the lips, tongue or face.
- Hypoglycemia (an abnormally low blood glucose level), which occurs most often when GLP-1 inhibitors are used in combination with a drug called a sulfonylurea or with insulin.
Adverse effects of albiglutide
Adverse effects linked to albiglutide differentiate it from the other approved drugs in its class. These effects include appendicitis, pneumonia, atrial fibrillation (an abnormal heart rhythm causing a rapid and irregular heart rate) as well as liver injury.[1]
One would not know it from the drug label, but the FDA was so concerned about liver toxicity that it called in its liver expert to examine in detail six cases of liver damage in people taking albiglutide in pre-approval clinical trials. The FDA expert concluded that the data “suggests that there is a plausible causal association.”
The seriousness of liver toxicity with albiglutide is downplayed in the drug’s label. Thus, health professionals may be unaware of it and unlikely to provide adequate patient monitoring, making it difficult to prevent liver injury now that the drug is on the market.[2]
In addition to revealing the adverse effects caused by the drug, the FDA statistical reviewer also questioned albiglutide’s effectiveness. He noted that the large amount of missing data from the clinical trials undermined the reliability of the results.[3]
Dubious trial
The design and results of one study comparing albiglutide with liraglutide (VICTOZA), another GLP-1 inhibitor, are questionable. The authors of the study concluded that participants taking daily liraglutide had greater reductions in blood sugar but more gastrointestinal adverse events, such as nausea and vomiting.
In this trial, gastrointestinal adverse effects occurred in 36 percent of patients taking albiglutide and 49 percent of those taking liraglutide. However, those taking once-weekly albiglutide had more injection site reactions, such as redness, rash and itching (which occurred in 13 percent of albiglutide and 7.5 percent of liraglutide subjects).[4]
But the trial was not blinded, meaning both patients and investigators knew what drugs the patients were taking; this exposes the trial to potential bias.[5] The trial was financed and managed by the maker of albiglutide, GlaxoSmithKline.
What You Can Do
Public Citizen’s Health Research Group designates albiglutide, and all other GLP-1 inhibitors, as Do Not Use because there are safer effective drugs available. An overview of the causes and treatments of Type 2 diabetes can be found on WorstPills.org.[6]
References
[1] Tanzeum (albiglutide) drug label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf. Accessed October 6, 2014.
[2] Vasisht K. Clinical review — albiglutide. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000MedR.pdf. Accessed October 7, 2014.
[3] Rothmann R. Statistical review — albiglutide. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000StatR.pdf. Accessed October 9, 2014.
[4] Ibid.
[5] Pratley RE, Nauck MA, Barnett, AH et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7). The Lancet Diabetes & Endocrinology. 2014;2:289-297.
[6] Type 2 diabetes: a guide to prevention and treatment. Worst Pills, Best Pills News. May 2014. /newsletters/view/901. Accessed October 7, 2014.
