Myopathy and the Statins?
Adverse Drug Reactions-Bulletin and Reporting
by Liz Baker BAppSc(Chiro)

At intervals I find myself pleasantly surprised by our not being excluded from the federal health care system. The Adverse Drug Reaction system is one such case.

The Adverse Drug Reactions Advisory Committee (ADRAC) and its secretariat, compile and assess reports of suspected ADR’s and issue bimonthly bulletins. Reports may be submitted by anyone, including members of the public.

So how important is this to the average COCA member? The bulletin regularly reports ADR’s in the musculoskeletal system, and we should be contributing reports ourselves.

Recent reports contain information pertinent to our everyday work. Statins, used for hypercholesterolaemia, cause myalgia, myopathy and rhabdomyolysis, particularly in the presence of multiple disease states and possibly interacting drugs. It’s a differential for those blokes in their 60’s with achey legs in bed. Creatinine kinase increase is one marker¹. Bisphosphonates-even oral Fosamax for osteoporosis- produce osteonecrosis of the jaw initially presenting as mild facial pain, rare, but occurring on our landmass². Adverse reactions to complementary medicines were reported in Feb 2005² including two recent Australian cases of liver failure requiring transplant after using Black Cohosh, and a range of effects of St John’s Wort including reduced efficacy of oral contraceptives. Back in ‘97 they were reporting parasthesias with NSAID’s, achilles tendinitis progressing to tendon rupture with fluoroquinolones³, and the first reports of a suspected class effect of the statins on muscle.

The Feb 2005 article on complementary medicines reported that a recent SA study had found that 52% of adults had used a complementary medicine in the preceding 12 months, and bemoaned the fact that 57% of these had not told their GP they were using it. Anecdotally patients are more likely to disclose complementary medicine use to non-medical practitioners, and thus we may have a significant role to play in reporting adverse reactions. Also ADR’s are often reported to us when the patient has no intention of returning to the GP, - “the doc prescribed x, I took a few, got a bad gut pain so I gave up on them. I’m just going to get by without the drug...”

The Australian Adverse Drug Reaction Bulletin is a free, one-cuppa item, 3 or 4 succinct articles per edition. The bulletin is available to all Australians. You can have yourself put on the mailing list for hard copies of the Australian Adverse Drug Reactions Bulletin by emailing your request with address to adrac@health.gov.au. Alternatively, you can receive electronic alerts of each bulletin issue by registering on the Australian Prescriber web site at www.australianprescriber.com and going to “new issue email alert”. The bulletin (with back issues from Feb 1995) is, of course available on the internet at www.health .gov.au/tga./adr/aadrb.htm. Information can be obtained from the ADRAC secretariat on 1800 044 114.

ADR reports may be made online www.tga.gov.au, or on a prepaid reporting form (“blue card”) obtained from the Adverse Drug Reactions Unit (02) 6232 8386, or print your own from www.tga.gov.au/adr/bluecard.pdf. A “blue card” also comes with each hard copy bulletin.

Australian Prescriber is another free, rigorously peer reviewed, publication relevant to us. It covers drug related issues, and also general diagnostic advice. The August 2005 edition had a practical article on the statins and muscle, and a beautiful overview article on the diagnosis and management of dizziness. It is available online only at www.australianprescriber.com.

With thanks to Kerry Baker, Pharmacist.

References

1. Aust Adv Drug Reactions Bull 23(1), Feb 2004.
2. Aust Adv Drug Reactions Bull 24(1), Feb 2005.
3. Aust Adv Drug Reactions Bull 16(2), May 1997.