Tag: Medicines & Healthcare products Regulatory Agency

MHRA: NO EVIDENCE that taking paracetamol during pregnancy causes autism in children

There is no evidence that taking #paracetamol during pregnancy causes autism in children.

Always follow NHS guidance and report any suspected side effects via the Yellow Card scheme https://bit.ly/2A6B165

Dr Alison Cave, Chief Safety Officer at the MHRA, said: “Patient safety is our top priority. There is no evidence that taking paracetamol during pregnancy causes autism in children.   

“Paracetamol remains the recommended pain relief option for pregnant women when used as directed. Pregnant women should continue to follow existing NHS guidance and speak to their healthcare professional if they have questions about any medication during pregnancy.

“Untreated pain and fever can pose risks to the unborn baby, so it is important to manage these symptoms with the recommended treatment. 

https://twitter.com/i/status/1970506529125064995

“Our advice on medicines in pregnancy is based on rigorous assessment of the best available scientific evidence. 

“Any new evidence that could affect our recommendations would be carefully evaluated by our independent scientific experts. 

“We continuously monitor the safety of all medicines, including those used during pregnancy, through robust monitoring and surveillance. We encourage anyone to report any suspected side effects to us via the Yellow Card scheme.”

Paracetamol is recommended as the first-choice painkiller for pregnant women, used at the lowest dose and for the shortest duration.

If pain does not resolve, then patients are advised to seek advice from their healthcare professional.

See NHS Guidance – Pregnancy, breastfeeding and fertility while taking paracetamol for adults 

Scottish Autism is aware that pronouncements regarding autism from the US Government will be a source of anxiety and worry for many in our community.

We are clear that public policy should be focused on recognising and accommodating the needs and rights of autistic people rather than stigmatising neurodivergence as something to be ‘treated’ or prevented. Spreading misinformation about the identified reasons why some people are born autistic does nothing to further this aim.

Scottish Autism’s focus is on finding better ways to support autistic people and their families. Our research, campaigning and service provision reflect this priority and always will.

Our Advice Line is open 10am-4pm Monday, Tuesday, Thursday & Friday and our Community Advisors can help you to identify what support may exist in your area.

You can call the Advice Line on 01259 222022, email advice@scottishautism.org or LiveChat with us via our website.

Women on “skinny jabs” must use effective contraception, MHRA urges

Anyone who suspects that they’ve had an adverse reaction to their weight loss or diabetes medicine or suspects it is not a genuine product, should report it to the MHRA. 

Women taking popular medicines for weight loss and diabetes, sometimes referred to as “skinny jabs”, are being reminded to use effective contraception while taking these medicines and, in some cases, for up to two months between stopping the medicine and trying to get pregnant.  

These medicines must not be taken during pregnancy, while trying to get pregnant, or during breastfeeding. Anyone who gets pregnant while using them should speak to their healthcare professional and stop the medicine as soon as possible. This is because there is not enough safety data to know whether taking the medicine could cause harm to the baby. 

Effective contraception includes oral (the pill) and non-oral (the implant, coil or condoms) forms of contraception. However, Mounjaro may reduce the effectiveness of oral contraceptives in those who are overweight. Therefore, those taking Mounjaro who are overweight and are using an oral form of contraception are advised to also use a non-oral form of contraception. This only applies to those taking Mounjaro and is especially important for the four weeks after starting Mounjaro and after any dose increase. 
 
This advice, which is already in the patient leaflets that come with the medicine, is just one of the reminders in the latest guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on the safe use of “GLP-1 medicines” known by the brand names Ozempic, Mounjaro, Wegovy, Saxenda and Victoza.  

The full advice can be found on the regulator’s website. It comes after concerns from the UK regulator that some people are not using these medicines for weight loss and diabetes safely.  

Dr Alison Cave, MHRA Chief Safety Officer said: “Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments. They are not a quick fix to lose weight and have not been assessed to be safe when used in this way. 

“Our guidance offers patients a “one stop shop” for our up-to-date advice on how to use these powerful medicines safely.  

“This guidance should not be used as a substitute to reading the patient information leaflet or having a conversation with a healthcare professional as part of the prescribing process. ” 

Alongside advice on contraceptive use, the MHRA reminds patients that these medicines should not be bought from unregulated sellers such as beauty salons or via social media, or taken without a prior consultation with a healthcare professional.

Not only does this expose people wanting to lose weight to serious health risks, it is also against the law to sell these medicines in this way. 

The only way to guarantee receiving a genuine GLP-1 medicine is to obtain it from a legitimate pharmacy.  

The guidance also reminds patients of the symptoms to look out for in the event of acute pancreatitis which, although uncommon, can be serious.

The main symptom of this is severe pain in the stomach that radiates to the back and doesn’t go away. Anyone who experiences this should seek immediate medical help. 

Summary of advice to patients

  • You should only take GLP-1 medicines if they have been prescribed to you by a healthcare professional.   
  • Always have a conversation with your prescriber about the benefits and risks of GLP-1 medicines before you start taking them.   
  • Do not take GLP-1 medicines if you are pregnant, trying to get pregnant or breastfeeding. If you get pregnant while using them, you speak to a healthcare professional and stop them as soon as possible.
  • If you are prescribed Mounjaro (tirzepatide), use a barrier form of contraception and do not rely on oral contraception.   
  • Understand the potential side effects and have a conversation with a healthcare professional if you are concerned.   
  • Tell your doctor you take a GLP-1 medicine if you are about to have surgery.   
  • Report any adverse reactions to the Yellow Card scheme.   
  • After taking the recommended four doses in each syringe, any medicine left in the syringe should not be extracted and the syringe should be disposed of in the bin.  
  • Use of these medicines is not a quick fix to lose weight and the MHRA has not assessed the safety and effectiveness of these medicines when used by people who do not meet the medical requirements.   

Anyone who suspects that they’ve had an adverse reaction to a GLP-1 medicine,  or suspects it is not a genuine product, should report it to the MHRA Yellow Card scheme.   

Safety withdrawal of pholcodine-containing cough and cold medicines

Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.

The Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of medicines under review and acts where necessary to protect patients and the public.

Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.

There is already a known link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery. In September 2022 the findings of a new study further strengthened the evidence of this link, but the overall risk is very small.

The MHRA advises that pholcodine-containing cough and cold medicines are being removed from the UK market as a precautionary measure.

Dr Alison Cave, MHRA Chief Safety Officer said: “Safety is our top priority, and we keep the safety of medicines under continual review.

“Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.

“If you are taking a cough or cold medicine, check the packaging, label or patient information leaflet to see if pholcodine is a listed ingredient. If it is, and you have any questions, you can talk to your pharmacist who will suggest an alternative medicine.

“If you have an operation scheduled using general anaesthesia, tell your anaesthetist if you think you have used pholcodine, particularly in the past 12 months. The anaesthetist will be well placed to take this into account. Anaesthetists are highly trained in managing anaphylaxis.

“If you want more information or advice, please speak to your pharmacist.”

See the MHRA Drug Safety Update