Zocor ( Simvastatin ) - UK Side Effect Reports


Other trade names of Simvastatin are Lipex, Simcard, Simlup and Simcor ( Simvastatin with Niacin.)

In the United Kingdom there exists an organization devoted to studying adverse drug reports (ADRs). This counterpart to the U.S. FDA ( Food and Drug Administration ) is the MHRA ( Medicines and Healthcare products Regulatory Agency.) However, there is a major difference in the way they operate. The MHRA organization actually studies the data, organizes it and makes it available to their medical community.

A friend of mine in England recently sent their report of Zocor ADRs to me as an information item. I consider it to be one of the most astonishing documents to come out of the statin era. I must assume that UK physicians take advantage of this. How else can they select treatment options?

Physicians in the United States are, with few exceptions, largely unaware of these statin drug side effect realities.

Drug Analysis Print (MHRA, UK)
Drug name: SIMVASTATIN
Period covered: From first marketing of Zocor ( Simvastatin ) in the UK in the early 1990s to 21-Nov-2008

Reported Problem from SimvastatinAll Fatal
Blood disorders  82  1
Cardiac disorders 172 10
Congenital disorders11 0
Ear disorders56 0
Endocrine disorders 14 0
Eye disorders 233 0
Gastrointestinal disorders 1167 4
General disorders  1004 13
Hepatic disorders16 2
Immune system disorders31 0
Infections 70 6
Injuries 75 0
Investigations 696 0
Metabolic disorders141 0
Muscle & tissue disorders 2058 12
Neoplasms  41 5
Nervous system disorders1267 2
Pregnancy conditions 16 2

Psychiatric disorders   

749 2
Renal & urinary disorders   218 3
Reproductive & breast disorders    187 0
Respiratory disorders    324 4
Skin disorders 1107 0
Social circumstances   7 0
Surgical & medical procedures    2 0
Vascular disorders  111 0
TOTAL NUMBER OF REPORTED REACTIONS  10055  66       

 

This is the actual report from MHRA, UK (same as the U.S. FDA). The FDA makes no comparable report of statin ADRs available to anyone to the best of my knowledge. The UK follow-up of post-marketing side effects appears to be far more transparent.

In comparing these two pieces of ADR information please remember that the percentage of cases actually reported is estimated to vary from 1% to 10%, so these figures should be multiplied by 10 to 100 to approximate true incidence of side effects.

Some of you may already have this information but it is the first time I have seen it. Of particular interest to me, the rhabdomyelitis incidence for Lipitor seems to be far higher than Zocor over a similar time period. Although Lipitor has far more cognitive events (mechanism being glial cell inhibition of brain cholesterol), Zocor seems to have more personality change events (mechanism being dolichol inhibition via mevalonate blockade resulting in altered neuropeptide synthesis.)

Cognitive dysfunction: there were 89 reports of amnesia of the transient global type and 29 cases of seriously affected memory associated with Zocor use. In addition 116 people were reported to have confusion and disorientation and 120  people were reported with extreme somnolence and lethargy.

Personality change: 126 people reported irritability, aggression, agitation, anger and personality change. 133 reported altered mood and restlessness and panic. 195 people reported depression and apathy. 256 reported insomnia, abnormal dreams or other sleep disorders. 27 reported disturbing hallucinations. 24 more reported suicidal ideation and morbid thoughts.

Nervous system: 305 people reported various peripheral neuropathy with burning pain, weakness and numbness. 89 cases of tinnitus and vertigo were reported. 154 reported disabling dizziness.

Skeletal system: 269 people complained of arthritis or arthralgia with joint stiffness and swelling.

Muscular system: 137 people reported with lupus like myositis, 646 reported myalgia, 174 reported muscle spasms, swelling and twitching. 131 complained of unusual and disabling muscle weakness. 320 reported severe back pain, soreness and stiffness. 156 complained of abdominal pain, which seemed to be of muscle origin. 292 rhabdomyopathy cases were reported. The usual death rate from rhabdomyolysis according to Sidney Wolfe is 10%.

Male reproductive system: 110 men reported loss of libido and erectile dysfunction.

Internal organs: 62 cases of hepatitis, 81 cases of cholecystic jaundice and 85 cases of abnormal liver function tests were reported. 56 people had pancreatitis and 18 cases of diabetes type 2 and increased insulin requirement were noted. 88 cases of renal failure were reported.

Hematopoetic system: 11 reports of anemia and 19 reports of thrombocytopenia were seen in Zocor users during this time period.

Cutaneous: 145 cases of alopecia were reported. 619 skin lesions of various types including maculopapular rashes, eczemas, severe itching and erythematous swellings were observed in Zocor users during this time period.

Respiratory: 127 reports of shortness of breath on exertion, 62 of asthma, cough and wheezing and 6 cases of respiratory failure were noted.

Cardiovascular: 91 reports of various types of palpitations and tachyarrthythmias were reported. 20 cases of new angina and 19 myocardial infarctions were observed in this patient population.

Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor

 


Books From Amazon

Cholesterol is Not the Culprit
The Statin Damage Crisis
Statin Drugs Side Effects
Lipitor, Thief of Memory


Over 12,000 reader posts:

spacedoc Forum