Posts Tagged ‘Medicines and Healthcare Products Regulatory Agency’

Pharmaceutical Scandal in Britain Sheds Disturbing New Light on Benzodiazepines

Saturday, November 13th, 2010

Psychology Today, November 12, 2010

by Christopher Lane, Ph.D.

Touted as the world’s first wonder drug, benzodiazepines—”benzos” for short—were widely prescribed in the 1960s for anxiety and stress. Within a decade they had become the most commonly used treatment for such conditions in the States and Britain. Use of benzos such as Valium, Mogadon, and Librium in both countries was widespread. Today, the same class of drugs—including Klonopin, Xanax, and Ativan—is still frequently prescribed for anxiety and panic. Widely known to be addictive and to cause a range of serious side effects, benzos became less popular in the 1980s and 1990s owing largely to the rise of SSRI antidepressants, which were widely considered to be safer and nonaddictive. A combined search for benzos and “adverse effects” on PubMed yields a staggering 15,157 hits, ranging from sleep disorders and increased violence among patients to discontinuation problems and dependency issues that bear all the hallmarks of a serious addiction.

With such widespread, well-publicized medical knowledge about this class of drugs, you might think doctors and psychiatrists would now shun them as excessively risky. But the drugs are still commonly prescribed for generalized anxiety and panic attacks. Healthy Place, which calls itself “America’s Mental Health Channel,” is far from alone in stating: “You can take benzodiazepines as a single dose therapy or several times a day for months (or even years). Studies suggest that they are effective in reducing symptoms of anxiety in approximately 70-80% of patients. They are quick acting. Tolerance does not develop in the anti-panic or other therapeutic effects. Generics are available for many, which helps reduce cost. Overdose is not dangerous.”

A new report on the drugs by Britain’s Independent is likely to dispel such thinking. According to the national newspaper, “the Medical Research Council (MRC) in Britain agreed in 1982 that there should be large-scale studies to examine the long-term impact of benzodiazepines after research by a leading psychiatrist showed brain shrinkage in some patients similar to the effects of long-term alcohol abuse.”

The Medical Research Council, founded in 1913,  is the agency in Britain responsible for co-ordinating and funding the nation’s medical research.

The only problem with the MRC’s response to such warnings about benzos? It appears to have sat for thirty years on the very documents that warned about the risks of brain shrinkage in patients taking them. Moreover, the MRC appears to have marked the documents “closed until 2014,” despite their obvious importance to public health, given the millions of Britons and North Americans who’ve been prescribed such drugs.

According to Nina Lakhani at The Independent, who has seen the documents, “no such [investigative] work was ever carried out [by the MRC] into the effects of drugs such as Valium, Mogadon and Librium—and doctors went on prescribing them to patients for anxiety, stress, insomnia and muscle spasms.”

“Members of Parliament and lawyers,” she continues,  “described the [recently revealed] documents as a scandal, and predicted they could lead the way to a class action costing millions. There are an estimated 1.5 million ‘involuntary addicts’ in the UK, and scores display symptoms consistent with brain damage.”

The chairman of the All-Party Parliamentary Group for Involuntary Tranquilliser Addiction, Jim Dobbin, is quoting as telling the same newspaper last week: “Many victims have lasting physical, cognitive and psychological problems even after they have withdrawn. We are seeking legal advice because we believe these documents are the bombshell they have been waiting for. The MRC must justify why there was no proper follow-up to Professor Lader’s research, no safety committee, no study, nothing to further explore the results. We are talking about a huge scandal here.”

Catherine Hopkins, the legal director of Action against Medical Accidents, is quoted as adding: “The failure to carry out research into the effect of benzodiazepines has exposed huge numbers of people to the risk of brain damage. This research urgently needs to be carried out, and if the results confirm the suspicions of the 1981 expert group, it could lead to one of the biggest group actions for damages against the Government and the MRC ever seen in the courts.”

One possible reason why the MRC sat on this story for thirty years? The regulatory agency in Britain that oversees the safety of medicines, the Medicines and Healthcare Products Regulatory Agency, is funded entirely by the drug companies it is meant to oversee. A 2005 parliamentary report in Britain spells that out with remarkable precision in paragraph 98 of its Fourth Report to the House of Commons:

“The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry (drug regulatory agencies in other countries are more often only partly funded by licence fees). The MHRA’s activities are 60% funded through licensing fees paid by those seeking marketing approvals and 40% through an annual service fee, also paid by the industry.”

That oddly revealed fact in a parliamentary report makes the MRC’s three-decade-long inaction over the health risks of benzos a fair bit easier to explain.

http://www.psychologytoday.com/blog/side-effects/201011/pharmaceutical-scandal-in-britain-sheds-disturbing-new-light-benzodiazepine

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The Daily Mail: UK Drug Regulatory Agency warns pregnant women of antidepressants danger to their unborn child

Monday, May 17th, 2010

The Daily Mail
By Jo MacFarlane
May 16, 2010

Women who use antidepressants while pregnant are being warned by health chiefs about the risks to their unborn child.

The Government’s medicines watchdog advised doctors there is an increased risk that babies will be born with a rare lung condition if expectant mothers take drugs such as Prozac and Seroxat.

The Medicines and Healthcare products Regulatory Agency (MHRA) is recommending they are monitored more carefully because of the risk of developing persistent pulmonary hypertension after birth.

The condition normally affects up to two in 1,000 births – but the latest research suggests the risk is more than doubled in women taking antidepressants, affecting five in 1,000 births. The life-threatening condition means infants do not adapt to breathing outside of the womb.

The risk is greater if the medicines known as SSRIs – a new generation of depression wonder drugs – are taken later in the pregnancy.

The warning comes five years after studies first showed there may be a link between the drugs and birth defects. The MHRA advised doctors not to prescribe the drugs to pregnant women unless necessary.

However, it was revealed last year that GPs were still prescribing them to women considering becoming pregnant.

Read entire article:  http://www.dailymail.co.uk/health/article-1278675/Pregnant-women-warned-antidepressants-danger-unborn-child.html?ito=feeds-newsxml

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UK Drug Regulatory Agency issues warning about potential birth defects from Prozac

Thursday, April 29th, 2010

Lawyers & Settlements
By Heidi Turner
April 28, 2010

London, England: The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency in the UK responsible for medicines and medical devices, has issued a warning about potential SSRI birth defects related to the use of fluoxetine (Prozac).

The MHRA issued the warning in its monthly drug safety update. The agency warns that there is a small risk of congenital cardiac defects in infants of mothers who took fluoxetine during the first trimester of pregnancy. According to the safety update, the risk is similar to that posed by paroxetine (Paxil/Seroxat).

The MHRA notes that an analysis of data from seven cohort studies found a slightly increased risk of congenital cardiac defects when fluoxetine was taken early in pregnancy. Those cardiac defects reportedly varied and ranged in severity from reversible ventricular septal defects to transposition of the great vessels. The safety update notes that the increased absolute risk is less than two per 100 pregnancies.

Prozac is an antidepressant classed as a selective serotonin reuptake inhibitor (SSRI). The MHRA says that there is not enough data to conclude that other SSRIs carry the same risk, but it is unwilling to rule out the possibility of a “class effect,” meaning other drugs in the same class may carry the same risks.

The agency also says that the risk of giving birth to an infant with congenital cardiac defects should be weighed against the risks of having untreated depression during pregnancy, which carries its own risks, including low birth weight, preterm delivery and lower Apgar scores.

Read entire article:  http://www.lawyersandsettlements.com/articles/14025/interview-ssri-birth-defects-side-effects-pphn.html

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UK: Pregnant women warned about antidepressants

Friday, March 12th, 2010

Bounty
March 12, 2010

Women expecting a baby have been warned over taking Prozac while they are pregnant, after a new study found it could be harmful to an unborn child.

According to a study from the Medicines and Healthcare Products Regulatory Agency there is a “small risk” of babies developing heart problems should their mother take the drug early on in their pregnancy.

The researchers behind the study said that pregnant mothers who use Prozac could be twice as likely to have children with a congenital heart problem, such as a murmur, or a hole in the heart.

Read entire article:  http://www.bounty.com/node/2191

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